Director, Regulatory Affairs CMC (Biologics, Combination Products)
Teva Pharmaceuticals
8 hours ago
Remote friendly (West Chester, PA)
United States
Corporate Functions
Position Summary
- Develop regulatory strategies to support development of innovative molecules and combination products and ensure efficient management of approved and marketed products.
- Compile, organize, and assess documents for regulatory submissions to major market health authorities; coordinate with global regulatory colleagues to prepare dossiers for global registration.
- Identify and evaluate CMC issues for molecule development products, including product/process development, device development, analytical methods, formulation development, manufacturing, and labeling.
- Maintain and update CMC sections of submissions and ensure quality of CMC responses to global health authorities.
- Interface with development, analytical, quality, and manufacturing teams; lead cross-functional CMC product teams; contribute to planning and conducting FDA meetings.
Major Duties and Responsibilities
- Provide CMC regulatory guidance by assessing FDA/ICH/EMEA guidances and directives; develop and communicate CMC regulatory strategies for development and post-marketing submissions; determine and communicate risk analyses and timeline development.
- Coordinate, author, and review CMC sections of IND, NDA, and CTA filings; compile/review CMC documents (e.g., Development Reports, Validation Protocols/Reports, NDA supplements, IND/NDA Annual Reports, and FDA information request responses); assist with regulatory correspondence submissions to FDA.
- Support global registration by liaising with regulatory counterparts in Europe, Israel, Canada, and Rest of World to prepare dossiers for foreign health authorities.
- Lead review of internal CMC controlled documentation (e.g., SOPs, test methods, specifications, protocols).
- Perform change management to establish regulatory impact and ensure compliance with registered commitments.
- Assist in planning and conducting meetings with regulatory agencies.
Education/Certification/Experience (Required)
- Bachelor’s degree (preferably scientific).
- 8+ years pharmaceutical industry experience.
- 5+ years Regulatory Affairs experience.
Skills/Knowledge/Abilities (Preferred)
- Advanced degree (M.Sci., Ph.D., PharmD).
- Technical experience in Analytical (QC/Analytical R&D), process/product development, or manufacturing.
- Knowledge of FDA and ICH guidelines.
- Experience with eCTD regulatory filings.
- Knowledge of U.S. and global/regional content requirements; drug development processes and lifecycle management.
- Clear, concise technical writing; ability to manage multiple projects and competing timelines.
- Ability to assess regulatory requirements/filing timelines and technical document quality; provide regulatory feedback.
- Ability to respond quickly with solutions to regulatory problems.
Benefits (Explicitly Stated)
- Comprehensive health insurance (medical, dental, vision, prescription) starting first day (if enrolled); 401(k) with employer match up to 6% and annual 3.75% defined contribution; Paid Time Off; company-paid life and disability insurance.
Application Instructions (If Present)
- Apply through Teva’s internal career site on Twist (internal candidates).
- Develop regulatory strategies to support development of innovative molecules and combination products and ensure efficient management of approved and marketed products.
- Compile, organize, and assess documents for regulatory submissions to major market health authorities; coordinate with global regulatory colleagues to prepare dossiers for global registration.
- Identify and evaluate CMC issues for molecule development products, including product/process development, device development, analytical methods, formulation development, manufacturing, and labeling.
- Maintain and update CMC sections of submissions and ensure quality of CMC responses to global health authorities.
- Interface with development, analytical, quality, and manufacturing teams; lead cross-functional CMC product teams; contribute to planning and conducting FDA meetings.
Major Duties and Responsibilities
- Provide CMC regulatory guidance by assessing FDA/ICH/EMEA guidances and directives; develop and communicate CMC regulatory strategies for development and post-marketing submissions; determine and communicate risk analyses and timeline development.
- Coordinate, author, and review CMC sections of IND, NDA, and CTA filings; compile/review CMC documents (e.g., Development Reports, Validation Protocols/Reports, NDA supplements, IND/NDA Annual Reports, and FDA information request responses); assist with regulatory correspondence submissions to FDA.
- Support global registration by liaising with regulatory counterparts in Europe, Israel, Canada, and Rest of World to prepare dossiers for foreign health authorities.
- Lead review of internal CMC controlled documentation (e.g., SOPs, test methods, specifications, protocols).
- Perform change management to establish regulatory impact and ensure compliance with registered commitments.
- Assist in planning and conducting meetings with regulatory agencies.
Education/Certification/Experience (Required)
- Bachelor’s degree (preferably scientific).
- 8+ years pharmaceutical industry experience.
- 5+ years Regulatory Affairs experience.
Skills/Knowledge/Abilities (Preferred)
- Advanced degree (M.Sci., Ph.D., PharmD).
- Technical experience in Analytical (QC/Analytical R&D), process/product development, or manufacturing.
- Knowledge of FDA and ICH guidelines.
- Experience with eCTD regulatory filings.
- Knowledge of U.S. and global/regional content requirements; drug development processes and lifecycle management.
- Clear, concise technical writing; ability to manage multiple projects and competing timelines.
- Ability to assess regulatory requirements/filing timelines and technical document quality; provide regulatory feedback.
- Ability to respond quickly with solutions to regulatory problems.
Benefits (Explicitly Stated)
- Comprehensive health insurance (medical, dental, vision, prescription) starting first day (if enrolled); 401(k) with employer match up to 6% and annual 3.75% defined contribution; Paid Time Off; company-paid life and disability insurance.
Application Instructions (If Present)
- Apply through Teva’s internal career site on Twist (internal candidates).