Manager Of Regulatory Affairs Jobs in Maryland

Job Title: Manager, Regulatory Affairs, International Company: MedImmune Location: Gaithersburg, MD Description: My company shares my passion for helping to improve human health around the world.” “This is My MedImmune.” Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities…that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world. Title: Manager, Regulatory Affairs, International Locaation: MD, Gaithersburg - Corporate Headquarters Req: 02255 Position Summary: Responsible for managing the collection, evaluation, preparation and assembly of nonclinical, clinical and CMC documentation required for international (ex-US) marketing applications for biologic products. Interacts with international marketing partners and internal project teams to ensure the timely completion of regulatory projects. Proactively identifies potential issues and recommends solutions to supervisor. Requirements: Major Duties and Responsibilities (including supervising others): 1. Serves as the Regulatory Affairs interface between designated international marketing partners and internal project teams with minimal supervision. 2. Develop regulatory strategies for the submission of international marketing applications, with an emphasis on European licensure strategies, and post-approval variations that are consistent with established regulatory policies and global regulations. 3. Establishes submission timelines and manages the receipt of information required to meet submission target dates. 4. Collaborate with global regulatory counterparts to develop global/regional/country regulatory strategy. 5. Conduct and analyze regulatory research to understand competitor activity and positioning and translate to regulatory strategy. 6. Lead the preparation of organized and scientifically valid regulatory submissions meeting the regulatory requirements of international health authorities; keen understanding of European CMC requirements is highly desired. 7. Reviews and determines the applicability, accuracy, and completeness of supporting documentation for inclusion in global regulatory submissions. 8. Lead activities in environmental risk assessments. 9. Participate and guide European Pediatric Investigational Planning for development products. 10. Remains current with all regulatory requirements and standards, with an emphasis on European requirements, necessary to obtain and maintain European and other international licensure for company products. 11. Interpret existing regulations and guidance documents within regulatory department and on project teams. 12. Provide guidance to project teams in the area of design and analysis for more straightforward projects. 13. Identify priorities and key issues in complex situations, and solves these problems with minimal assistance. 14. Plan, coordinate, prepare and execute for meetings with regulatory agencies. 15. Ensure corporate and partner compliance with established company quality policies, practices, SOPs, and applicable US, EU and ROW regulations. 16. Responsible for the maintenance of regulatory documentation. 17. May manage and supervise associate level staff including defining work products and expectations, organizing and prioritizing projects, and providing mentoring to facilitate staff development and training. 18. Occasional travel (up to 10%) may be required to ensure efficient communication and expedite submissions. Requirements/Qualifications: Education: BS/MS in a scientific discipline, such as chemistry or biochemistry, or equivalent experience. Experience: Minimum of 4 years experience in the pharmaceutical/biotech industry with 2-3 years of increasing documented success in Regulatory Affairs, preferably with biologics/biotech products. Must have knowledge and understanding laws, regulations, and guidelines pertaining to international product registration. Experience in vaccine product development and registration is highly desirable Special Skills/Abilities: 1. Global functional/technical skills, with an emphasis on CMC; experience in biologic and genetically manipulated products is a plus. 2. Ability to interpret, understand and comply with international regulatory requirements. 3. Strong organizing skills, ability to multi-task and to manage time effectively 4. Excellent oral and written communication skills 5. Act quickly in response to management objectives and changing project priorities 6. Self-motivated and proactive worker 7. Possess professional ethics (integrity and trust) 8. Proficiency in the use of Microsoft Word and other software programs 9. Strong interpersonal /group skills with ability to direct, motivate and influence others 10. Capable of working collaboratively with colleagues in all functions. 11. Proven leadership qualities and ability to negotiate successful outcomes. 12. Ability to appropriately assess risks and formulate risk-management strategies. 13. Attention to detail and accuracy Job Complexity: Works on problems of diverse scope where analysis of situation or data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Able to read large volumes of printed material in a short period of time and be able to identify inconsistencies, incomplete and/or inaccurate information, provide corrections, and changes. Supervision: Manages and coordinates regulatory projects, works independently with minimum supervision.  If you are interested in this position please — Apply online at www.medimmune.com/careers and search for Req #. 02255 MedImmune is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law. MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune’s approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune’s approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.

Job Title: Regulatory Affairs Manager II Company: Location: Baltimore, MD Description: Regulatory Affairs Manager II The Clinical Monitoring Research Program (CMRP) provides comprehensive programmatic/project and procurement management support to NCI's cancer Human Biobank (caHUB) program. The Regulatory Affairs Manager provides direct regulatory oversight support to the caHUB efforts of the Office of Biorepositories and Biospecimen Research (OBBR). Responsible for providing technical assistance and expert oversight for the development of regulatory strategies related to collection, annotation, storage, and profiling of tissues. Coordinates the planning, scheduling, preparation, and review of informed consent forms, material transfer agreements, and other related regulatory documents associated with caHUB. Serves as a liaison for clinical investigators and other clinical regulatory staff providing regulatory guidance as well as review and expertise to ensure documentation conforms to applicable regulations and guidelines. Responsible for monitoring key ethical and legal issues related to protection of research participants, adherence to policies for the appropriate use of biospecimens, and adherence to federal and state regulations surrounding the collection, storage, dissemination, and use of biospecimens. This position will be located in Rockville, Maryland. REQUIRED SKILLS: Possession of a Bachelors degree from an accredited college/university in a health/scientific, or medically related field or four (4) years related experience in lieu of degree. Masters degree preferred. In addition to education requirements, a minimum of eight (8) years of progressively responsible regulatory experience. Ability to work in a clinical research setting both independently and within a team to build strong relationships with multiple groups. Required to exercise good judgment in planning and accomplishing goals. Must be detail-oriented and possess strong organizational/planning skills and the ability to prioritize multiple tasks/projects. Demonstrated excellent written and verbal communication skills. Possess knowledge of clinical trial fieldwork concepts and practices as well as expertise in managing IRB submissions and approvals, expertise in HIPAA regulations, material transfer agreements, regulatory and quality assurance procedures and ICH guidelines. Proficiency in Microsoft Excel, Word, and Outlook. Must demonstrate working knowledge of scientific principles. Please respond with resume and salary requirements.

Job Title: Regulatory Affairs Manager II (NCI) Company: SAIC Location: Rockville, MD Description: Regulatory Affairs Manager II (NCI) Full Time    Regular posted 12/11/2009   Job Category HTH - Health Services Req ID 163158 Able to obtain security clearance? None Currently possess security clearance? None Location Rockville, MD   % Travel Relocation No Requirements To discuss this opportunity with members of our team, please join us at one of our upcoming open houses! Tuesday, March 9th from 3:30pm to 7:30pm at the Hampton Inn, 5311 Buckeystown Pike, Frederick, MD or Thursday, March 18th from 3:30pm to 7:30pm at the Bethesda North Marriott, 5701 Marinelli Road, Bethesda, MD. THIS IS AN AMERICAN RECOVERY AND REINVESTMENT ACT (ARRA) FUNDED POSITION. The Clinical Monitoring Research Program (CMRP) provides comprehensive programmatic/project and procurement management support to NCI's cancer Human Biobank (caHUB) program. The Regulatory Affairs Manager provides direct regulatory oversight support to the caHUB efforts of the Office of Biorepositories and Biospecimen Research (OBBR). Responsible for providing technical assistance and expert oversight for the development of regulatory strategies related to collection, annotation, storage, and profiling of tissues. Coordinates the planning, scheduling, preparation, and review of informed consent forms, material transfer agreements, and other related regulatory documents associated with caHUB. Serves as a liaison for clinical investigators and other clinical regulatory staff providing regulatory guidance as well as review and expertise to ensure documentation conforms to applicable regulations and guidelines. Responsible for monitoring key ethical and legal issues related to protection of research participants, adherence to policies for the appropriate use of biospecimens, and adherence to federal and state regulations surrounding the collection, storage, dissemination, and use of biospecimens. This position will be located in Rockville, Maryland. REQUIRED SKILLS: Possession of a Bachelors degree from an accredited college/university in a health/scientific, or medically related field or four (4) years related experience in lieu of degree. Masters degree preferred. Foreign educated candidates who have completed part or all of their education outside of the United States must have their foreign education evaluated by an SAIC-approved accrediting organization to assure that it has met the equivalency of the qualifications of degree work in the United States. In addition to education requirements, a minimum of eight (8) years of progressively responsible regulatory experience. Ability to work in a clinical research setting both independently and within a team to build strong relationships with multiple groups. Required to exercise good judgment in planning and accomplishing goals. Must be detail-oriented and possess strong organizational/planning skills and the ability to prioritize multiple tasks/projects. Demonstrated excellent written and verbal communication skills. Possess knowledge of clinical trial fieldwork concepts and practices as well as expertise in managing IRB submissions and approvals, expertise in HIPAA regulations, material transfer agreements, regulatory and quality assurance procedures and ICH guidelines. Proficiency in Microsoft Excel, Word, and Outlook. Must demonstrate working knowledge of scientific principles. This position is subject to obtaining a Public Trust Clearance. DESIRED SKILLS: Hands-on experience in ethical and legal policies with regards to clinical research, knowledge of federal and state regulations including HIPPA, ICH and GCP, experience in oncology and biospecimens preferred.

Job Title: Associate Director, Regulatory Affairs Company: MedImmune Location: Gaithersburg, MD Description: Title: Associate Director, Regulatory AffairsLocation: MD, Gaithersburg - Corporate HeadquartersReq: 02157Position Summary:This is a leadership position, responsible for preparing, implementing, communicating, and coordinating regulatory projects, plans and schedules with scientific (clinical and nonclinical), and business development project team members for assigned biological products. Responsible for collecting, preparing and assembling documentation required to initiate and maintain Investigational New Drug Applications, and Biologic License Applications. REQUIREMENTS - QUALIFICATIONS: Associate Director, Regulatory Affairs Major Duties and Responsibilities:1. Lead development of innovative regulatory strategy for all phases of drug development for biological investigational products2. Monitor product related corporate activities for regulatory compliance, including all nonclinical and clinical plans and practices.3. Represent Regulatory Affairs at project meetings and other governance related meetings, providing guidance to Research, Clinical Development and Manufacturing at Project Team meetings.4. Manage and lead a group of Regulatory professionals of up to 4 direct reports, each of whom may also have direct reports.5. Interact with responsible departments and lead preparation, review, and assembling of the scientific (nonclinical, clinical, and manufacturing) and administrative sections of submissions to US, national and international regulatory agencies.6. Lead submission of regulatory information to FDA and world-wide regulatory agencies including, but not limited to, INDs, BLAs, CTAs and manufacturing, preclinical and clinical protocols and amendments, and adverse experience reports. 7. Plan, coordinate, prepare and execute meetings and teleconferences with regulatory agencies. 8. Prepare, manage, and coordinate clinical trial applications and clinical trial labeling with world-wide Contract Research Organizations and Consultants.9. Review and determine the applicability of supporting documentation for inclusion in regulatory submission.10. Contributes critical review of all documentation supporting regulatory applications.11. Interact with Company Partners and Consultants for various regulatory matters as needed.12. Remain current on Regulatory Intelligence, new guidance documents and the like in order to provide fully informed participation in development programs.13. Must be action oriented, have customer focus and excellent time management and organizing skills14. Contribute the Regulatory perspective as required on Due Diligence activities in support of potential new business opportunities.

Job Title: Sr. Manager Regulatory Affairs Company: Emergent Biosolutions Location: Gaithersburg, MD Description: Employer Information About Emergent Biosolutions As a leading biopharmaceutical company, Emergent BioSolutions Inc., develops, manufactures and commercializes immune-related biologics, vaccines and biotherapeutics to prevent or treat infections and other life-threatening diseases. More than 500 employees strong, our vibrant organization offers and exceptional environment for career satisfaction and growth. Job KEY RESPONSIBILITIES: Qualified candidate will serve as the regulatory representative on Product Development Teams and provide regulatory support and advice for the teams. Will facilitate regulatory strategy development and implementation for Product Development Teams, take the lead on regulatory submissions for product and provide authoring, review, and coordination for quality submissions to regulatory agencies. Will also prepare for meetings, teleconferences, and other communications with FDA (including read-ahead packages and/or other necessary documentations), educate teams regarding regulatory risks and implications for strategy and product development activities, and utilize technical knowledge and effectively apply regulations and guidelines to the product development process.

Job Title: Regulatory Affairs Manager II Company: SAIC Location: Frederick, MD Description: THIS IS AN AMERICAN RECOVERY AND REINVESTMENT ACT (ARRA) FUNDED POSITION. The Clinical Monitoring Research Program (CMRP) provides comprehensive programmatic/project and procurement management support to NCI's cancer Human Biobank (caHUB) program. The Regulatory Affairs Manager provides direct regulatory oversight support to the caHUB efforts of the Office of Biorepositories and Biospecimen Research (OBBR). Responsible for providing technical assistance and expert oversight for the development of regulatory strategies related to collection, annotation, storage, and profiling of tissues. Coordinates the planning, scheduling, preparation, and review of informed consent forms, material transfer agreements, and other related regulatory documents associated with caHUB. Serves as a liaison for clinical investigators and other clinical regulatory staff providing regulatory guidance as well as review and expertise to ensure documentation conforms to applicable regulations and guidelines. Responsible for monitoring key ethical and legal issues related to protection of research participants, adherence to policies for the appropriate use of biospecimens, and adherence to federal and state regulations surrounding the collection, storage, dissemination, and use of biospecimens. This position will be located in Frederick, Maryland. Possession of a Bachelors degree from an accredited college/university in a health/scientific, or medically related field or four (4) years related experience in lieu of degree. Masters degree preferred. Foreign educated candidates who have completed part or all of their education outside of the United States must have their foreign education evaluated by an SAIC-approved accrediting organization to assure that it has met the equivalency of the qualifications of degree work in the United States. In addition to education requirements, a minimum of eight (8) years of progressively responsible regulatory experience. Ability to work in a clinical research setting both independently and within a team to build strong relationships with multiple groups. Required to exercise good judgment in planning and accomplishing goals. Must be detail-oriented and possess strong organizational/planning skills and the ability to prioritize multiple tasks/projects. Demonstrated excellent written and verbal communication skills. Possess knowledge of clinical trial fieldwork concepts and practices as well as expertise in managing IRB submissions and approvals, expertise in HIPAA regulations, material transfer agreements, regulatory and quality assurance procedures and ICH guidelines. Proficiency in Microsoft Excel, Word, and Outlook. Must demonstrate working knowledge of scientific principles. This position is subject to obtaining a Public Trust Clearance.

Job Title: DVC Regulatory Affairs Manager ( Company: CSC Location: Baltimore, MD Description: Title: DVC Regulatory Affairs Manager (Scientist Principal Leader)Location: MD: MARYLAND-FREDERICKEssential Job Functions* Responsibilities and Duties (including all essential job functions): The Regulatory Affairs Manager is responsible for overseeing and coordinating the regulatory strategy of DVC's recombinant vaccine against a bacterial toxin, with the objective of achieving FDA licensure using the US FDA's "Animal Rule". The Regulatory Affairs Manager serves in a matrixed team comprising manufacturing, nonclinical, clinical and scientific experts and is the primary point of contact with FDA, Europe, Canada and international regulatory authorities. He/she advises program/teams on regulatory requirements, coordinates & presents regulatory data needs, and negotiates with and influences management, colleagues and partners to ensure regulatory data requirements are met. Responsibilities include:* Assists the Associate Director Regulatory Operations in the preparation and assembly of submissions to regulatory agencies* Facilitates the interactions between DVC and regulatory agency personnel to expedite resolution of new and on-going agency/company issues* Reviews submissions for accuracy and verification of CMC, Clinical, and Nonclinical data* Interfaces with internal departments to oversee the support and ensure timely submissions to regulatory agencies.* Leads in communicating with regulatory agencies* Develops regulatory filing strategies in support of domestic and international filing initiatives* Proactively identifies potential product development problems/issues and develop corrective action plans for resolution* Maintains proficiency in current applicable FDA guidelines and regulations* Serves as a technical resource to the regulatory development area by focusing on product and technology regulations, product development, and product enhancements.* Facilitates customer/supplier relationships to improve competitive advantage in the marketplace. Builds and facilitates relationships to enhance networks and create appropriate focus.* The candidate must be able to work both independently and as a member of matrixed teams and working groups. The candidate must demonstrate flexibility and an ability to manage regulatory strategy within a matrixed organization. Creative problem-solving skills and an ability to apply those skills to development of a biologic are essential.Basic Qualifications* Bachelor's degree or equivalent combination of education and experience* BS/MS in Biological Sciences with previous experience in one or more of the following research areas: biochemistry, bacteriology, molecular biology or engineering.* Candidate must demonstrate strong technical training in manufacturing including validation of processes or assays.* A minimum of five years experience managing regulatory development of a CBER-regulated biologic, with experience interacting directly with the FDA as a point of contact.* The candidate must demonstrate technical competence in a relevant scientific area, with preference given to candidates with strong experience negotiating regulatory strategy during the pre-BLA to licensure stage of development and/or stong CMC validation knowledge.* The candidate must have demonstrated experience interacting with senior level scientists.* The candidate must have strong team-building and interpersonal skills as well as strong oral and written communication skills.* Experience working with the biotechnology regulatory industryOther Qualifications* Good analytical and problem solving skills* Good organization skills to balance and prioritize work* Good interpersonal skills to interact with customers and team members* Leadership skills to provide work guidance to less experienced personnel on projects* Ability to work independently and as part of a team

Job Title: Regulatory Affairs Manager/Specialist - IVD Experience Needed Company: Location: Baltimore, MD Description: Regulatory Affairs Manager/Specialist - IVD Experience Needed -------------------------------------------------------------------------------- Date: 2010-03-05, 7:33PM CST Reply to: job-tmv2f Register to View Register to View [Errors when replying to ads?] -------------------------------------------------------------------------------- Regulatory Affairs Manager Grifols has been a leader in the healthcare industry since 1940 by creating innovative products and services based on the values of ethics, quality and responsibility. Grifols' activities focus on fulfilling the needs of its patients as well as healthcare professionals working in therapeutics, pharmacy, diagnostics and blood banking. For more than 60 years, Grifols has developed, manufactured and marketed product designed to improve human health. At its Los Angeles facility, Grifols manufactures plasma derived biopharmaceutical products of proven efficacy, quality and safety. The Grifols family of companies, including Grifols Inc., Grifols USA, Grifols Biologicals, Biomat USA and Plasma Collection Center, Inc. For more information, please visit our website: http://www.grifolsusa.com/. Grifols Inc. is the company that sets the corporate policies of all Grifols companies in the US (Grifols Biologicals, Biomat USA and Grifols USA). Also, it provides shared services on Human Resources, Information Technologies, Accounts Payables, Controlling, Audits, Planning and Finance and Regulatory Affairs. This company has an immediate opening for a Regulatory Affairs Manager offering an excellent benefits package, including medical, dental, vision, 401(K) plan, life insurance, educational assistance, and generous paid time off. Position Summary: ?Reports to the Regulatory Affairs (RA) Director. Incumbent must have excellent written and verbal communication skills, be well-organized, very detail-oriented, and be able to multi-task. The incumbent must be able to interact effectively within project teams to achieve group goals; and must have the ability to withstand pressure when work priorities change and/or timelines accelerate. The position requires negotiation of project completion timelines with internal commercial and external project leaders. Position requires continuous scheduling of activities and projects as demands and target dates change. Job Responsibilities: (This job description is accurate at the date of publication and may change over time. It is not intended as an exhaustive description of the job. Other duties may be assigned and qualifications required may change.) ?Responsible for the planning, review and preparation of In Vitro Diagnostics (IVD) documents for pre-IDEs, premarket notification or 510(k), and BLA submissions to the CDRH, CBER, U.S. FDA. ?Review IVD performance studies for autoanalyzers and other clinical automation and analysis instrumentation, and diagnostic test kits related to immunology, blood banking, hemostasis and clinical diagnostic test kits in general. ?Be familiar with FDA-required standards, e.g., EP-A2, EP6-A, EP7-A2, EP9-A2, EP17-A. ?Alert management and information suppliers of gaps in the studies and provide recommendations and action items. ?Review FDA IVD guidance documents and update management of changes in the regulatory requirements which will impact the company. ?Project planning ? write project plans with target due dates to complete milestones. Monitor changes, inform relevant parties involved. Solve problems, take actions as required, and work in an efficient manner to ensure milestones are met by target dates. ?Represent the department in meetings, both regulatory and commercial in nature. Interact effectively with quality, regulatory, research personnel within the company, internal business managers and external suppliers/distributors in order to complete projects in a timely manner. ?Prepare electronic 510(k) submissions. ?Train personnel and write regulatory SOPs. Required Skills, Experience & Education: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions). ?Mimimum of B.S. degree required. ?5 years minimum experience in regulatory submissions in the in vitro diagnostic device industry, preferably in immunology, blood banking, clinical chemistry and hemostasis, and with both instrumentation and reagents. ?Strong computer skills required. Knowledgeable in Access, Word, Excel, Statistical software, e.g., Analyse-It ?Excellent verbal and written communication skills ? must have technical writing ability. ?Strong interpersonal skills with ability to interact with personnel at all levels. ?Must be capable of multi-tasking with the ability to work well with others in a TEAM environment. To submit your resume please click or copy & paste the link below, or visit our Careers Website at www.grifolsusa.com http://hostedjobs.openhire.com/epostings/submit.cfm?fuseaction=app.dspjob&company_id=16052&jobid=216852&jobboardid=632 Location: Los Angeles Compensation: Salary Depends on Experience, generous PTO, benefits, 401k matching

Job Title: DVC Regulatory Affairs Manager (Scientist Principal Leader) Company: CSC Location: Frederick, MD Description: Job Title:DVC Regulatory Affairs Manager (Scientist Principal Leader)Job Number:10001JVJob Category:Analytic ServicesPrimary Location:USA-MD: MARYLAND-FREDERICKSchedule:Full-timeJob Type:RegularEmployee Status:RegularTravel:Yes, 25% of the time Job Posting:2010-Feb-10 DescriptionEssential Job Functions Responsibilities and Duties (including all essential job functions): The Regulatory Affairs Manager is responsible for overseeing and coordinating the regulatory strategy of DVC's recombinant vaccine against a bacterial toxin, with the objective of achieving FDA licensure using the US FDA's "Animal Rule". The Regulatory Affairs Manager serves in a matrixed team comprising manufacturing, nonclinical, clinical and scientific experts and is the primary point of contact with FDA, Europe, Canada and international regulatory authorities. He/she advises program/teams on regulatory requirements, coordinates & presents regulatory data needs, and negotiates with and influences management, colleagues and partners to ensure regulatory data requirements are met. Responsibilities include: Assists the Associate Director Regulatory Operations in the preparation and assembly of submissions to regulatory agencies Facilitates the interactions between DVC and regulatory agency personnel to expedite resolution of new and on-going agency/company issues Reviews submissions for accuracy and verification of CMC, Clinical, and Nonclinical data Interfaces with internal departments to oversee the support and ensure timely submissions to regulatory agencies. Leads in communicating with regulatory agencies Develops regulatory filing strategies in support of domestic and international filing initiatives Proactively identifies potential product development problems/issues and develop corrective action plans for resolution Maintains proficiency in current applicable FDA guidelines and regulations Serves as a technical resource to the regulatory development area by focusing on product and technology regulations, product development, and product enhancements. Facilitates customer/supplier relationships to improve competitive advantage in the marketplace. Builds and facilitates relationships to enhance networks and create appropriate focus. The candidate must be able to work both independently and as a member of matrixed teams and working groups. The candidate must demonstrate flexibility and an ability to manage regulatory strategy within a matrixed organization. Creative problem-solving skills and an ability to apply those skills to development of a biologic are essential. Qualification Basic Qualifications Bachelor's degree or equivalent combination of education and experience BS/MS in Biological Sciences with previous experience in one or more of the following research areas: biochemistry, bacteriology, molecular biology or engineering. Candidate must demonstrate strong technical training in manufacturing including validation of processes or assays. A minimum of five years experience managing regulatory development of a CBER-regulated biologic, with experience interacting directly with the FDA as a point of contact. The candidate must demonstrate technical competence in a relevant scientific area, with preference given to candidates with strong experience negotiating regulatory strategy during the pre-BLA to licensure stage of development and/or stong CMC validation knowledge. The candidate must have demonstrated experience interacting with senior level scientists. The candidate must have strong team-building and interpersonal skills as well as strong oral and written communication skills. Experience working with the biotechnology regulatory industry Other Qualifications Good analytical and problem solving skills Good organization skills to balance and prioritize work Good interpersonal skills to interact with customers and team members Leadership skills to provide work guidance to less experienced personnel on projects Ability to work independently and as part of a team Remote Work Location Authorized:No Relocation Assistance:Not Available Clearance Level:None

Job Title: Manager Regulatory Affairs Company: MedImmune, LLC Location: Gaithersburg, MD Description: Title: Manager Regulatory AffairsLocation: MD Gaithersburg - Corporate HeadquartersReq: 02251Major Duties and Responsibilities (including supervising others):1. Provides regulatory guidance during the review and evaluation of change controls quality investigations quality audits that may impact existing or pending licenses or authorizations.2. Provides regulatory support during inspections by regulatory agencies. Works with QA and Compliance to develop corrective action plans and formulate responses to inspectional findings.3. Provides strategies consistent with established regulatory policies and global regulations to members of assigned project teams in order to facilitate approval of CMC supplements and variations. 4. Interacts with responsible departments and manages the collection review and assembly of administrative and CMC sections of submissions to regulatory agencies. Submissions projects may include but are not limited to IND/IMPD/BLA/Annual Reports/ Distribution Reports/MAA/NDA/DMF/Site Master Files/MA/IMP.5. Establishes submission timelines and manages the timely and comprehensive receipt of information required to meeting submission target dates.6. Reviews and determines the applicability accuracy and completeness of supporting documentation for inclusion in regulatory submissions. 7. Ensure corporate and partner adherence to and compliance with established company quality policies practices SOP's and applicable US EU and ROW regulations.8. May manage and supervise associate level staff including defining work products and expectations organizing and prioritizing projects and providing mentoring to facilitate staff development and training.9. Must have excellent oral and written communication skills.10. Occasional travel to manufacturing sites may be required to ensure efficient communication and expedite submission development. Travel will be in range of 10 – 15% each year.Special Skills/Abilities: Applied knowledge of FDA and EU regulations GMP and post-approval CMC experience is required. Specific experience in vaccine development and commercial support highly desirable. Job Complexity: Works on problems of diverse scope where analysis of situation or data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Detail oriented. Able to read large volumes of printed material in a short period of time and be able to identify inconsistencies incomplete and/or inaccurate information provide corrections and changes. Supervision: Manages and coordinates regulatory projects works independently with minimum supervision. (Supervision required level of independence)Educations: Requirements/Qualifications:Education: Minimum BS/MS in a scientific discipline or equivalent experience. Advanced degree a plus. Experience: Minimum of 5 years experience in the Pharmaceutical/Biotech Industry with 3 years of related regulatory experience. CLICK HERE TO APPLY MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law. Learn About MedImmune View All MedImmune Opportunities Send This To A Friend