Director Of Regulatory Affairs Jobs in Maryland

Job Title: Senior Director, Regulatory Affairs (Princeton) Company: Otsuka Location: Rockville, MD Description: Senior Director, Regulatory Affairs (Princeton) Detailed Description The Senior Director, Regulatory Affairs provides regulatory expertise and support for pre-clinical, clinical and commercial areas for investigational and marketed products. Ensures development of the drugs are in accordance with global regulations in order to approve drugs quickly and smoothly within typical approval timeframes. Ensures marketed products are supported with minimal questions and issues from the regulatory agencies. Establishes well-defined regulatory pathways and creates accurate and timely documents for IND and NDA submission and final approval. This position will be based in Princeton, New Jersey. Specific duties include the following: Provides strategic regulatory leadership and guidance to the project teams. Designs programs for complete and accurate IND/CTA submissions and ensure that clinical trials as designed meet regulatory requirements. Defines regulatory expectations for teams, identifies elements of INDs and FDA required preparation, positions response to regulatory agencies, defines strategy for negotiations and formal document submission, and provides strategic input in the development of the plan. Interacts with regulatory agencies and ensures conversations and communications are focused, amicable and documented. Oversees the submission of product registration of new drugs, progress reports, supplements, amendments, and periodic adverse experience reports. Develops strategies, drafts responses, and/or reviews responses and documents intended for submission to FDA and other Health Authorities in collaboration with regional regulatory affairs to assure compliance with regulatory standards. Oversees the review of documents/reports generated by RA support staff or contractors or other project team members to assess the likelihood that the content will meet pre-specified objectives, and provides input towards this end. Serves as part of Global Product Development Committee, monitoring the products with the affiliates as well as co-licensing. Responsible for management, monitoring, oversight, strategic development, and global labeling approvals when it comes to the alliance. Recruits, trains, and coaches staff; evaluates employee performance on an ongoing basis, and completes annual performance reviews. Travel 20-30% Job Requirements The qualified candidate will meet the following minimum requirements: Advanced degree with 10+ years experience in regulatory affairs in pharmaceutical or healthcare related industry and including 6 years of supervisory experience. Experience in leading FDA meetings across multiple FDA divisions. Comprehensive knowledge of the drug development process, labeling and promotional reviews, drug laws, global regulations and guidelines. Comprehensive understanding of the global regulatory agencies. Proven success of submitted SNDA , IND and NDA. Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). Strong analytical skills and problem solving ability. Strong communication and presentation skills. Knows how/when to apply organizational policy or procedures to a variety of situations. Additional Details We offer a competitive compensation and benefits package plus a positive work environment, which encourages personal growth and achievement. How To Apply For immediate consideration, qualified candidates should apply now. Due to the volume of resumes, only applicants considered for interviews will be contacted. Otsuka is an Equal Opportunity Employer.

Job Title: Associate Director Director, Regulatory Affairs Company: MedImmune Location: Gaithersburg, MD Description: Title: Associate Director/Director, Regulatory AffairsLocation: MD, Gaithersburg - Corporate HeadquartersReq: 02542Major Duties and Responsibilities (including supervising others):1. Utilize expert technical regulatory skills, with an emphasis on CMC skills, of self and others to collaborate on strategies and influence international regulators on complex issues regarding the influenza vaccine with significant future implications for pan- Business and Regional strategies.2. Influence the international perspective and decision making on new biologic product development.3. Identify opportunities for MedImmune position based upon interpretation of the International Regulations and Guidances.4. Network internally throughout the MedImmune and AZ organizations to gather knowledge and information.5. Align to development and business priorities and influence resource allocation and budget decisions.6. Advise key groups on international submission requirements.7. Analyze and resolve international submission issues and identify new content as needed.8. Develop regulatory strategies, oversee and manage the submission of international influenza vaccine marketing applications, with an emphasis on European licensure strategies, and post-approval variations that are consistent with established regulatory policies and global regulations; collaborate with International regulatory counterparts to develop international/regional/country regulatory strategy.9. Manage communication with key internal stakeholder groups and International Health Authorities on Regulatory-related issues; establishes submission timelines and manages the receipt of information required to meet submission target dates.10. Conduct and analyze regulatory research to understand competitor activity and positioning and translate to regulatory strategy.11. Reviews and determines the applicability, accuracy, and completeness of supporting CMC and other documentation for inclusion in international regulatory submissions.12. Lead and manage activities in environmental risk assessments involving a genetically modified medicinal product in support of international submissions.13. Remains current with international regulatory intelligence including all regulatory requirements and standards, with an emphasis on ICH and European requirements, necessary to obtain and maintain European and other international licensure for company products.14. Provide guidance to project teams in the area of design and analysis for complex projects.15. Identify priorities and key issues in complex situations, and solves these problems with minimal assistance.16. Plan, prepare and execute for meetings with international regulatory authorities.17. Monitor product-related corporate activities for regulatory compliance, including all manufacturing, preclinical and clinical plans and practices18. Provide regulatory support during international regulatory agency inspections and other compliance activities; work with RA representative for QA/Operations to review corrective action plans and the formulation of responses to inspectional findings.19. Ensure corporate and partner compliance with established company quality policies, practices, SOPs, and applicable US, EU and ROW regulations.20. Possibly 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.21. Occasional travel (up to 25%) may be required to ensure efficient communication and expedite submissions.

Job Title: Manager, Regulatory Affairs-Labeling Company: MedImmune, LLC. Location: Gaithersburg, MD Description: Manager, Regulatory Affairs-Labeling Location: MD, Gaithersburg - Corporate Headquarters Req: 02617 Major Duties and Responsibilities (including supervising others): 1. Lead cross-functional teams in the development and lifetime maintenance of the CDS, USPI and other regional labeling for assigned therapeutic area(s) 2. Provide tactical guidance to Labeling Working Groups/Global Labeling Committee regarding language, placement, and regulatory content detail for regional prescribing information and CDSs 3. Provide precedent searches and comparison matrices 4. Manage corporate review and approval of all CDSs, USPIs and other regional prescribing information 5. Issue CDSs and monitor implementation across regions 6. Ensure consistency in prescribing information across products and therapeutic areas 7. Ensure corporate quality standards for prescribing information are met 8. Maintain repository of all labeling documents, ensuring version control and document integrity of internal draft, Agency-submitted and Agency-approved labels 9. Represent functional expertise at all relevant department meetings 10. Participate in the development and maintenance of policies, SOPs, and associated documents relating to corporate oversight of regional prescribing information 11. Train process contributors on corporate labeling practices 12. Provide comments regarding regional labeling guidance changes 13. Liaise with senior management as needed to resolve critical labeling issues 14. Ensure regional submission timelines are met as appropriate 15. Provide guidance to the junior regulatory staff as need arises 16. Perform functions of significant scope with minimal supervision 17. Assist in other regulatory activities as required

Job Title: Regulatory Affairs Manager (Job #97) Company: Polaris Search Group Location: Gaithersburg, MD Description: Regulatory Affairs - Project ManagerJob DescriptionPosition Summary:Reporting to the Associate Director for Regulatory Operations Systems, this position will support [the 's] ongoing regulatory initiatives by assisting in the planning and implementation of departmental information systems required for Regulatory Operations. The role provides system analysis, business analysis, and technical support for the implementation, validation, and life cycle management of Regulatory systems/databases. The position also includes involvement in the full system development lifecycle and requires knowledge of the project implementation and management process. This will involve participation in workshops, interviewing key staff, authoring and reviewing related requirement documents, and providing support in the selection, implementation, and validation of Regulatory systems/databases.Major Duties and Responsibilities (including supervising others):Assists in the analysis and implementation of Regulatory systems/databases by:Defining and authoring user requirement specificationsParticipating in the selection of Regulatory systems/databasesAssisting in the design, build (as needed), testing, validation, and documentation processesPerforming project management activities (as needed)Tracks status of all ongoing Regulatory system projectsRecommends system improvements and coordinates implementationAssists in providing system automation needs and support for RegulatorySupports system-related initiatives in support of Regulatory submissionsActs as liaison between Regulatory and IT by:Ensuring departmental strategy integrates with enterprise-wide IT technology strategyInforming the IT department of Regulatory's IT needsEnsures validation requirements are in with FDA 21CFR Part 11 and related regulationsCreates an effective, collaborative relationship with ITInitiates new solutions to aid in the automation of Regulatory processes by being aware of advancements in scientific technologies and current Regulatory guidelines

Job Title: MANAGER REGULATORY AFFAIRS - LABELING Company: The Judge Group, Inc. Location: Baltimore, MD Description: Manager Regulatory Affairs - Labeling. Education: BS/MS in a scientific discipline such as chemistry, pharmacy, biology or biochemistry etc. Advanced academic training is highly desirable. Responsible for coordinating the initial creation and subsequent revisions of CDSs, USPIs and other regional labeling for assigned products. Ensures that CDSs, USPIs and corresponding regional prescribing information provide all essential information for the safe and effective use of the product. Experience: A minimum of 4 years of increasing documented success in regulatory affairs (preferably in labeling) with an additional 5 years or more in a relevant field of pharmaceuticals/biotechnology. Work experience in a biopharmaceutical arena is highly desirable. Experience working in a GMP pharmaceutical environmental. Competent knowledge of FDA regulations (current Code of Federal Regulations and FDA Guidances) and ICH guidelines preferred. Thorough understanding of and demonstrated ability to apply US/EU regulatory guidelines pertaining to product labeling, and CIOMS III/ V guidelines. Lead cross-functional teams in the development and lifetime maintenance of the CDS, USPI and other regional labeling for assigned therapeutic area(s) 2. Provide tactical guidance to Labeling Working Groups/Global Labeling Committee regarding language, placement, and regulatory content detail for regional prescribing information and CDSs 3. Provide precedent searches and comparison matrices 4. Manage corporate review and approval of all CDSs, USPIs and other regional prescribing information 5. Issue CDSs and monitor implementation across regions 6. Ensure consistency in prescribing information across products and therapeutic areas 7. Ensure corporate quality standards for prescribing information are met 8. Maintain repository of all labeling documents, ensuring version control and document integrity of internal draft, Agency-submitted and Agency-approved labels see attached Job ID: JO131761 Please refer to job code JO131761 when responding to this ad.

Job Title: Regulatory Affairs Manager for DynPort Vaccine Company Company: Computer Sciences Corporation Location: Frederick, MD Description: The Regulatory Affairs Manager is responsible for overseeing and coordinating the regulatory strategy of DVCs recombinant vaccine against a bacterial toxin, with the objective of achieving FDA licensure using the US FDAs 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.Assists the Associate Director Regulatory Operations in the preparation and assembly of submissions to regulatory agenciesFacilitates the interactions between DVC and regulatory agency personnel to expedite resolution of new and on-going agency/company issuesReviews submissions for accuracy and verification of CMC, Clinical, and Nonclinical dataInterfaces with internal departments to oversee the support and ensure timely submissions to regulatory agencies.Leads in communicating with regulatory agenciesDevelops regulatory filing strategies in support of domestic and international filing initiativesProactively identifies potential product development problems/issues and develop corrective action plans for resolutionMaintains proficiency in current applicable FDA guidelines and regulationsServes 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.

Job Title: MANAGER REGULATORY AFFAIRS Company: The Judge Group, Inc. Location: Baltimore, MD Description: Manager, Regulatory Affairs need for pharmaceutical company Must have 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. Ideally candidate will have some Internationa/Globall exp- (preferred but not required). Manufacturing, quality- CMC, and regulatory experience. Submission mgt experience, ECDT. Submissions projects may include but are not limited to IND/IMPD/BLA/Annual Reports/ Distribution Reports/MAA/NDA/DMF/Site Master Files/MA/IMP. Full relocation provided. RESUMES to Register to View JO#144007 Job ID: JO144007 Please refer to job code JO144007 when responding to this ad.

Job Title: Manager, Regulatory Affairs, International Company: MedImmune, LLC. Location: Gaithersburg, MD Description: 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.

Job Title: Regulatory Affairs Manager - Biotechnology / Reagents Company: MRINetwork Location: Baltimore, MD Description: Regulatory Affairs Manager Medical Devices A Regulatory Affairs Manager is urgently needed in the Maryland / DC area with a company that has a very broad product base including biotechnology, lab equipment, reagents, and pharmaceutical products. There are multiple openings at several levels for people with regulatory affairs talent and experience in medical device / pharmaceutical / Biotech industries. This is a strong and growing company with excellent promotability and benefits. A relocation package is available for the right candidate. QUALIFICATIONS BS/BA minimum. Advanced degrees are a plus 5+ years experience in Regulatory Affairs of medical devices Experience managing a multiple projects and driving them to completion Broad knowledge of software driven electrical medical devices Please respond to this advertisement by attaching your resume in MS Word format to an email addressed to Register to View and John Boynton at MRI Atlanta Peachtree North will give you a call if you meet the requirements. Please send me a link if you are interested in joining my network of 8300+ industry executives on LinkedIn.

Job Title: Manager, Regulatory Affairs Company: MedImmune, LLC. Location: Gaithersburg, MD Description: Manager, Regulatory Affairs Location: MD, Gaithersburg - Corporate Headquarters Req: 02251 Major 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.