Teva Senior Director Regulatory Affairs CMC Biologic Products 

United States, Pennsylvania, East Bradford Township 

256416786

The Sr. Director, Global Regulatory Affairs CMC is responsible to oversee and help develop regulatory strategies to support development of innovative biologic products, as well as to ensure efficient management of approved and marketed products. The responsibilities of the role include influencing the strategy and assessing the quality of documents for regulatory submissions to major market health authorities as well as coordinating with global regulatory colleagues in preparing dossiers for global registration.

This position comes with 4 direct reports (Dir, Sr Manager, Manager & Associate III).

The Sr Director, Regulatory Affairs CMC is responsible for identifying and evaluating CMC issues associated with product development including product and process development, device development, analytical methods, formulation development, manufacturing, and labeling.

Major Duties and Responsibilities

⦁ Develop and communicate effective CMC regulatory strategies for development and post marketing submission activities. Determine and communicate appropriate risk analyses and timeline development.

⦁ Coordinate, author and review the CMC sections of IND, NDA and CTA filings. Compile and review CMC regulatory documents, including but not limited to Development Reports, Validation Protocols and Reports, NDA supplements, IND and NDA Annual Reports, and Responses to FDA information requests. Assist in the submission of regulatory correspondence to the FDA.

⦁ Support the global registration initiative for marketed products by liaising with Regulatory counterparts in Europe, Israel, Canada and Rest of World assisting with preparation of complete registration dossiers to be submitted to foreign Health Authorities.

⦁ Lead the review of internal CMC controlled documentation including but not limited to standard operating procedures, test methods, specifications and protocols

⦁ Assist in planning and conducting meetings with regulatory agencies for routine meetings and interactions.

Minimum Knowledge and Skills Required

⦁ Bachelor’s degree in scientific discipline.
⦁ Minimum 10 years of pharmaceutical industry experience.
⦁ Minimum 6 years of Regulatory Affairs experience with biologics and devices
⦁ Managerial experience expected

Knowledge and Skills Preferred

⦁ Advanced degree ( M.Sci., Ph.D., PharmD) is preferred.
⦁ Relevant technical experience in Analytical (QC, Analytical R&D), process/product development, or manufacturing is preferred.
⦁ Knowledge of FDA and ICH Regulatory guidelines
⦁ Experience with eCTD regulatory filings
⦁ Knowledge of U.S. and global content and regional requirements
⦁ Experience with biologic combination products (auto injectors, pre-filled syringes, wearable sensors, etc)
⦁ Knowledgeable in drug development processes and life cycle management of products
⦁ Clear, concise technical writing skills
⦁ Ability to manage multiple projects and competing timelines
⦁ Ability to assess regulatory requirements and filing timelines in order to judge the work required for submission of a quality filing
⦁ Ability to assess technical quality of documents and to provide regulatory feedback to colleagues
⦁ Ability to respond quickly with reasonable solutions and alternatives to regulatory-related problems
⦁ Good interpersonal, communication and organizational skills.

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