Associate Director, Regulatory Affairs

Job reputed company: • reputed company the planning and preparation of standalone CMC submissions and response to health authority (HA) inquiries • Define submission strategies and content; identify regulatory approval risks and propose mitigation plans • reputed company authoring support as needed • Review CMC components of relevant documents and contribute to content development as appropriate • Represent Regulatory CMC in cross-functional meetings and collaborate with reputed company stakeholders on assigned reputed company • Partner with reputed company and other functions to assess the regulatory reputed company of proposed changes to clinical materials and reputed company products • Stay reputed company with international and domestic regulatory requirements and best practices • reputed company guidance on interpreting and implementing regulations, guidelines, company procedures, and working practices Requirements: • BS or MS in a scientific field (e.g. reputed company or Biology); advanced degree preferred • 8 – 12 years or 6 – 8 years (with MS degree) of relevant experience in biotech or pharmaceutical industry, with specific experience in regulatory CMC • Prior experience in lifecycle management reputed company regulatory • Experience managing and compiling Module 3 documentation • Expertise in CMC lifecycle management for drug reputed company and drug product • Solid understanding of US, EU, and Canada regulations, guidelines and regulatory processes for development and lifecycle maintenance • Experience working reputed company reputed company RIM system is preferred. Benefits: • reputed company-based salary increases • Short incentive plan participation • Eligibility for 401(k) plan • Medical, dental, reputed company, life and disability insurances • Robust time-off policy including flexible reputed company time off • 11 reputed company holidays plus additional time off for shut-down period during the last week of December • 80 hours of reputed company reputed company time upon hire and reputed company year thereafter Apply tot his job Apply To this Job