Director Of Regulatory Affairs Jobs

Job Title: Senior Manager / Associate Director, Regulatory Affairs Company: Global Recruiters Network Location: Waltham, MA Description: Company The company is a biopharmaceutical company dedicated to bringing best-in-class critical care and hospital-based therapeutics to patients. Company’s strategy is to in-license clinical-stage drug candidates and develop them for markets with clear unmet medical needs. Description Primary responsibilities include being the Regulatory Affairs representative for the assigned projects; generation, review and compilation of regulatory submissions and serve as lead on assigned agency communications. This position will develop and implement initiatives aimed to ensure the successful and timely completion of the drug candidate Phase 2b clinical trials and all related clinical trial milestones. Responsibilities Responsible for the preparation of quality document packages required for IND amendments, Master files, and other regulatory submissions. Reviews submission related documents such as safety reports, clinical protocols, Investigator’s Brochure, SOP’s process descriptions, change controls to ensure compliance with FDA regulations and ICH guidelines. Assists in the development and maintenance of organizational systems for the department’s operational functions Ensures quality document filing (electronic and hard copy) of each assigned project. Maintains high level of regulatory knowledge of current GMP, GLP, and GCP regulations. Monitors the issuance of revised and new FDA & ICH regulations concerned with biologics. Assist Senior VP of Regulatory Affairs and Quality Compliance in activities associated with liaison to external collaborators, and scientific institutions/associations on regulatory issues.

Job Title: Director of Regulatory Affairs Company: The Institute for Transfusion Medicine Location: Pittsburgh, PA Description: The Institute for Transfusion Medicine is located in Pittsburgh, Pa. and is the parent company of Central Blood Bank located in Pittsburgh, Pa. and Lifesource, located in Chicago, Illinois. This position is responsible for the preparation, submission, monitoring, and follow-up activities related to the Regulated activities as required by the FDA, State, and Accreditation agencies. This position will be accountable for the overall oversight of these regulated activities and assure that they are handled in a timely and accurate manner. Will frequently confer with the operational departments regarding regulatory changes that impact the Regulatory compliance of the ITxM organization. This position must act as the liaison with the Regulatory and Accreditation agencies and manage the correspondence and communication to the appropriate ITxM personnel. Essential duties/responsibilities include, but are not limited to the following: Prepares/submits FDA BPDRs; Prepares/submits FDA Regulatory submissions; Keeps licenses, registrations, and accreditation documentation current; Keeps abreast of current changes in regulations or accreditation requirements; Prepares summaries and reports; Communicates with the regulatory and accreditation authorities as appropriate. BA or BS degree in Life Science is required. You will need to have a minimum of 2 years in QA or RA and a minimum of 5 years of experience in an FDA-regulated environment. Excellent verbal and written communication skills are essential for this position. 2 years experience in blood banking or transfusion service is highly desirable. This position requires travel between Pittsburgh and Chicago on a regular basis. For more information and to apply; please go to our web site at http://www.centralbloodbank.jobs/ You must apply on our website for consideration.

Job Title: Regulatory Affairs Manager Company: Westat Location: Rockville, MD Description: Regulatory Affairs Manager (Requisition # WJ/HS/8426) ORIGINAL JOB LISTING Job Title: Regulatory Affairs Manager JobCode: WJ/HS/8426 Division: Research Staff JobCategories: Healthcare - All, Quality Assurance / Testing Status: Full-Time Salaried WestatArea: Health and Medical Studies Location: Rockville, MD Description: The Regulatory Affairs (RA) Unit of the Clinical Trials area is seeking an individual who will have day-to-day management responsibility for the RA Unit under the direction of the RA/QA director. Qualified candidates will have a strong regulatory background with an emphasis on clinical trials and clinical safety reporting. Responsibilities include: managing ongoing regulatory projects; IND development and maintenance; compliance reviews of protocols, informed consents and other trial documents; oversight of the organization and maintenance of Trial Master Files and SOP review and compliance. Individual will also be responsible for the preapproval pharmacovigilance component of the RA Unit including oversight of the safety database, reporting procedures, and review and management of the Serious Adverse Experience reports (SAE) for domestic, international, commercial, and Government-sponsored clinical trials; RA Unit development and planning; and participation in proposal writing and project team meetings. A bachelors degree in a life science or health care curriculum, with 4+ years of regulatory experience in the pharmaceutical, biotech, or clinical research industry, including management experience, is required. Must be able to work in a team environment and possess strong organizational, time-management, and written and oral communication skills. Knowledge regarding Federal regulations, and FDA, ICH/GCP, and OHRP guidelines is required. Proficiency in Microsoft Office including Access is desirable. Posting Date : 2008-06-30 05:00:49 Westat Homepage Employees Worldwide: 3,400 Employees in Local Area: 1,900 Annual Revenue: $475,000,000 Westat, headquartered in Rockville, Maryland, near Washington, DC, is an employee-owned research corporation serving agencies of the U.S. Government, state and local governments, businesses, and foundations. We conduct surveys and program evaluations, provide statistical research, and offer related services. Our multiproject environment provides career opportunities in health, energy, education, transportation, the environment, human services, and the workforce. We combine the relevant research area expertise with the capabilities to perform major survey research projects: study design and analysis, methodology, survey data collection, information technology, and web evaluation and design. Westat offers information technology and data processing capabilities, including developing computer-assisted interviewing systems and integrating them with the survey process. Our staff includes senior statisticians who have international reputations in survey sample design and statistical analysis. We also provide wide-ranging capabilities with statistical processing and data management systems. Westat is a full-service research organization. Westat's diverse benefits program is our way of sharing our success with employees, rewarding teamwork, and encouraging professional growth: Employee Stock Ownership 401(k) Annual Cash Bonus Professional Development Programs Insurance Coverage

Job Title: Director, Regulatory Affairs Company: Location: Cheshire, CT Description: Reports to the Sr. Director, Regulatory Affairs. Is responsible for strategic definition/direction and implementation of all Cheshire based regulatory strategies, and ensures that these strategies are consistent with company objectives. Interacts with members of other departments/areas to plan, compile, write, modify, etc. documentation to be sent to FDA or other regulatory agencies, in support of (e.g.) IND, BLA, DMF, MAAs or other regulatory applications as needed. Leads all strategic liaison activities with US and Canadian Regulatory agencies. This position will be the primary point of contact with licensing/development partners for regulatory strategic matters. The incumbent will be responsible for the growth and adaptation of the Regulatory Affairs department to meet the needs of the company. Will represent the company as needed for regulatory affairs matters. Main Responsibilities Lead the Regulatory Affairs Department in the required regulatory related strategy for all research & development candidates and approved products, including line extensions. Participates in the development project teams to create and communicate regulatory strategy, and for strategic planning and submission of documentation to regulatory agencies as appropriate, such that development timelines and compliance with regulations can be maintained. Will be responsible for ensuring that Alexion is in compliance with regulatory requirements for all ongoing projects. Assures that the documentation being provided to regulatory authorities meets standards for completeness and compliance with regulations and company best practices. Ensures that communications with other groups (QA, QC, Manufacturing, Process Development, clinical, research, etc) to write and generate such documentation occurs and when necessary take the lead in generation / authoring of documents. Acts as the liaison within Alexion for information requests to and from Regulatory agencies, and is responsible for tracking their progress. Acts as main Alexion contact for any contract manufacturers, licensers, consultants, etc. regarding timely writing and transfer of regulatory related documentation to/from Alexion. Will be the lead Regulatory member on project teams for new development candidates, and will participate in the strategy to develop product in a timely fashion, thus expediting generation of clinical supplies, process development and analytical development, in support of new INDs and first in human clinical studies. Visa Sponsorship Not Available for this Position Education Requirement: Skill Requirements Advanced degree or equivalent education in a science. M.S / PhD, R.Ph., Pharm D. (preferred). At least 10 years prior experience in Regulatory Affairs within the Pharmaceutical Industry, preferably biotech, or equivalent experience. Past experience with oncology and/or hematology research / development desirable. Proven experience in regulatory liaison activities with regulatory agencies, including prior achievement of product approvals, filing of INDs, NDAs, BLAs, MAAs, CTAs, CTXs, etc. Experience in several regulatory disciplines (e.g. clinical development, CMC, preclinical, advertising and promotion, pre and post-approval activities, product launches, etc.) would be a strong plus. Good oral and written communication skills. Ability to handle changing priorities and multidisciplinary tasks. Incumbent must possess sense of urgency, people skills and be able to thrive in a team oriented, visible small company environment. Self motivation, team sprit and open communication are essential. Notes: Alexion Pharmaceuticals is a publicly traded company engaged in the development of novel drugs for the treatment of hematologic disorders, autoimmune diseases, cardiovascular disorders and cancer. Alexion offers a highly competitive package of base and incentive compensation, group healthcare coverage, tuition reimbursement, relocation assistance, a 401(K) plan and stock options. Alexion is an Equal Opportunity/Affirmative Action Employer. Principals only, no agency calls

Job Title: Associate Director Regulatory Affairs Company: Location: Ellicott City, MD Description: CSG has become a leading resource for clinical professionals seeking new contract, contract-to-hire, and/or direct opportunities. Our reputation allows our candidates access to the most desirable positions in the industry depending on where their respective interests lie. We offer full benefits including medical, dental, vision, life insurance, short/long-term disability, 401K, referral bonuses, training reimbursement, relocation, and continuing education. CSG is also in a position to work with individuals on a 1099 basis. Our firm is consistently seeking top-notch professionals to join our team in a consulting capacity. Should your interest be a permanent role, CSG has multiple opportunities to suit your needs. The selected candidate will be responsible for compiling and processing US IND, CTD, Annual reports, DMF, NDA and BLA submissions and assisting with all Regulatory Affairs /Quality Assurance department needs. In this role, you will ensure timeliness of deliverables; edit/format/review regulatory documents; and work with staff in resolving regulatory issues and/or problems. Ensure that the company adheres to all applicable regulations. Additionally, you may serve as the team member for specific projects; be responsible for gathering and entering regulatory information related to specific projects; perform regulatory and/or quality assurance reviews of data or reports; attend project meetings, professional meetings, seminars and workshops; and document all phases of involvement in any specific project

Job Title: Associate Director, Regulatory Affairs Company: Abbott Laboratories Location: Milwaukee, WI Description: Position Description This position is located in Abbott Park, IL - but we are recruiting out of Southeastern Wisconsin for qualified candidates. Job Title Associate Director, Regulatory Affairs AutoReqId 54227BR Job Family COMPLIANCE/REGULATORY AFFAIRS Job Category Full-Time Job Classification Experienced Division Pharmaceutical Products Group Shift. First Job Description The Associate Director Regulatory Affairs defines and implements US regulatory strategies and priorities in conjunction with Global Products Regulatory Affairs colleagues. Ensures application of established policies and best practice regulatory standards within US Regulatory for all filings and agency interactions. Assures consistent review of promotional materials, reviews non-routine items with staff, and negotiates regulatory position on issues where cross-functional team has reached impasse. Serves as strategic regulatory partner to the commercial brand team both pre and post-approval. Assesses programs (including clinical development) and attends meetings to provide strategic input and negotiate with internal colleagues to ensure US regulatory data requirements are met to support strategic regulatory filing and promotional efforts. Manages the processes to achieve FDA input (via meetings & submissions) to Research & Development programs. Manages interface with FDA for key projects/issues, including direct negotiation with review division personnel, and DDMAC reviewers. Manages the preparation and review of regulatory submissions to assure effective presentation of data, complete and timely response to FDA during application review, and quality consistent with US regulatory requirements and guidelines. Participates in Medical and Regulatory review meetings as appropriate to define direction, review and, discuss issues and negotiate agreement on promotional issues. Manage several regulatory professional staff members. Skills/Experience Requirements 8-10 years experience in Regulatory, Research & Development or related area with minimum 5 years in Regulatory. Education Requirements Bachelor Degree in Pharmacy, Biology, Chemistry, Pharmacology or related subject.Advanced degree is preferred. Percentage of Travel 10% Country USA State/Province/Region Illinois Site Location: For corporate headquarters positions, please select Abbott Park,IL and Lake County,IL Lake County,IL *** when applying say you found this position on WisconsinJobNetwork.com ***

Job Title: Regulatory Affairs Manager Company: Scientific Search Location: Bethlehem, PA Description: To manage activities within the Regulatory Affairs Department to ensure that all goods manufactured and services provided by the company meet the quality requirements of the company, regulatory and notified bodies. Ensure that all departments involved in the manufacture and sale of product comply with procedures designed to achieve and maintain the product and company quality standards. Responsibilities Manage and organize the Regulatory Affairs department ensuring that departmental objectives are implemented in line with the overall Quality/Corporate goals. Ensure compliance with the U.S.A FDA Code of Federal Regulations, the European in Vitro Diagnostic Directives, EN 13485 and other Quality Standards as appropriate. This includes, but is not limited to, the design input, review, out-put and verification, validation, transfer and change control. Provide updates as needed to supervisor regarding regulatory status and requirements, both U.S. and European, of Company products. This includes the implementation of CE marking to products in accordance with IVDD 98/79/EEC. Compile device master records, technical files, design dossiers, FDA and European submission documents, and/or any other related documents/reports, ensuring timely submissions to CBER and TUV etc., to meet Company product(s) and regulatory requirements, and compliance to all approved licenses. Ensure staff understands and complies with the requirements of cGMP as applied to the Company’s product(s). Provide related training and support to departments as needed. To review Change Control requests, deviation requests, quality system reports for adequacy and compliance with company and regulatory requirements. Responsibility for Biologic Product Deviation Reports in compliance with the Code of Federal regulations. To participate in the investigation of failures and participate in continuous improvement initiatives. Write and maintain procedures relating to the Regulatory affairs function, the preparation and presentation of quality reports, data and Key Performance Indicators for management reviews. To provide regulatory support as required in the evaluation of customer complaints, ensuring complaint reports are closed out in accordance with the approved procedure. Participate in the development, management, and maintenance of the Company’s Quality System to meet the requirements of US FDA (21CFR 820 QSR), ISO9001, ISO 13485, EN 13485, MDD, IVDD and all other applicable quality and regulatory standards. Responsibility for ensuring Post Market surveillance/ vigilance systems, liaising with others in the quality departments, QA/QC. Update the RA/QA Director of any serious and/or adverse events. As appropriate, deputies for other members of the RA/QA department. Maintain current knowledge of related trends, regulations, etc. Comply with and maintain the Company’s Quality Systems. Complete other tasks as assigned by the SVP, RA/QA.

Job Title: Manager, Regulatory Affairs Company: The Merwin Group Location: Boston, MA Description: At The Merwin Group, we specialize in the placement of outstanding talent in the biotechnology industry, combining a proven, targeted methodology and individual industry expertise to match the best candidates with the right companies. Client Information Our client is a global biotechnology leader, focusing on autoimmune disorders and oncology. Summary The Manager, Regulatory Affairs assists in the preparation of global regulatory strategies and manages the submission and approval of applications for clinical trials and marketing applications, full submissions and variations in 3 ICH regions. Essential Duties & Responsibilities Represent Global Regulatory Affairs in Global Project Teams Lead Global Regulatory Affairs sub-tea Manage the regulatory submission process through to approval, including management and coordination of the preparation of all regulatory documentatio Manage the regulatory agency interactions, document preparation, co-ordination rehearsals and minutes (may be under supervision of a Therapeutic Head or delegate) Prepare regulatory strategies for projects (may be under supervision) Review of protocols, reports and all types of regulatory documentation (quality, safety, efficacy, and labeling) including CTAs

Job Title: Regulatory Affairs Manager Medical Device Company: Location: Philadelphia, PA Description: Regulatory Affairs Manager Medical Device Our client has a high priority need in its Regulatory Affairs group for an experienced Medical Advice RA Manager. This is a great opportunity for someone with a minimum of three years of experience, and offers potential for you to leverage your experience and take your career to the next level while working with a top-notch team. In this position, you will play an integral role in Regulatory Affairs group . Extensive Medical Device Regulatory Affairs experience doing Advertising and Promotional review and an understanding of Regulatory Strategy are required. Experience in a Project setting is desirable. Great opportunity to expand on your Project Management skills and increase your potential in the ever expanding Regulatory Affairs marketplace. Your day-to-day responsibilities will be directly determined not only by your previous experience, but also by your desire to take on challenges. If you have experience in some of these areas and are looking to round out your arsenal, we would be interested in speaking with you about this position. *** NOTE: We have requirements for similar opportunities (both permanent and contract) in other locations around the country, and for client projects in Europe. If you have expertise in Regulatory Operations and would be interested in discussing available opportunities (either permanent or contract positions), please contact Register to View to discuss. *** Visit www.kleinhersh.com to view additional job opportunities available through our company.

Job Title: Sr Manager/Director of Regulatory Affairs Company: Juvaris BioTherapeutics, Inc. Location: Burlingame, CA Description: SUMMARY: Juvaris BioTherapeutics, Inc. is developing and commercializing therapeutic vaccines and immunostimulants for the treatment of infectious diseases, cancer and severe allergy using its novel technology platform. The development stage company is seeking a Director of Regulatory Affairs to implement and conduct all regulatory activities. Develop and implement strategies for earliest possible approvals of phase 1 through phase 4 applications. Provide professional expertise and strong leadership in the development and implementation of regulatory strategies, including meetings with domestic and international regulatory authorities, CMC, clinical trial functions, and issues related to biological product development, submissions, and compliance. DUTIES AND RESPONSIBILITIES: Specific activities include, but not limited to the following: · Plan, organize, and prepare documents and regulatory submissions for domestic and international product development and registration. · Work with management to develop, plan, organize and implement regulatory strategy. · Participate in product planning to assure timely, smooth, and efficient development of regulatory submissions for clinical trials and product registration. · Provide regulatory guidance to functional area to ensure understanding, rapid and effective development of regulatory document requirements needed for timely submissions. · Primary interface with regulatory agencies. · Establish SOPs for effective operation of the Regulatory Affairs department, including interfacing with other departments to oversee/coordinate the development of regulatory procedures and controls to ensure product compliance in a timely manner. · Ensure timely preparation of organized and scientifically valid submissions, including INDs, to appropriate governmental agencies to meet regulatory requirements. · Coordinate all related government and compliance activities within the organization during and after inspections, or during regulatory actions by government agencies. · Recommend appropriate regulatory changes for labeling, manufacturing, and marketing to assure regulatory compliance. · Remain current with all regulatory requirements and standards necessary to develop and obtain licensure for therapeutic vaccines. JOB REQUIREMENTS: Skills required in the following: · Strong cross-cultural communication skills. · Ability to manage contract personnel. · Strong organizational skills. · Detail oriented. · Ability to prioritize and handle multiple tasks simultaneously. · Ability to work independently and in a team environment. · Dedication to quality and reliability in all work tasks. · Self motivation, eagerness to grow professionally and commitment to self-development. · Willingness to travel domestic & international as necessary, consistent with the project needs. EDUCATION AND EXPERIENCE: · Bachelor’s degree with minimum of 7 years applicable experience in the regulatory affairs of biological products, MS degree preferred. · Extensive knowledge and understanding of laws, regulations, and guidelines pertaining to new drug development/vaccine therapy and registration. · Knowledge of US and International regulatory practices and procedures. · A minimum of ten years of experience in positions of increasing scope and responsibility in regulatory affairs (including regulatory oversight of CMC and Clinical Trials). · M ust be familiar with cGMP/GLP, GCP and Regulatory Guidelines as applied in start-up and mature biopharmaceutical companies. · Must have successful experience in preparation of INDs, CTDs, NDAs, BMFs, and BLA submissions, including amendments. · Demonstrated experience having primary responsibility for major regulatory submission including successful FDA interface/negotiations. · Demonstrated ability to lead managers, consultants and others from product discovery and research through approval and product introduction. · Regulatory Affairs Certification (RAC) desirable. COMPENSATION : Salary base will be competitive with the field and experience. Compensation package includes base salary, stock options, vacation time, sick leave, paid holidays and benefits. Benefits include medical, dental, vision, life insurance, short-term and long-term disability insurance, flexible spending account plan and 401(k) plan. Please Note: This position is located in Burlingame, California - No relocation package is offered.