Job Description:
• Lead 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
• Provide 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 internal and external stakeholders on assigned projects
• Partner with Quality and other functions to assess the regulatory impact of proposed changes to clinical materials and commercial products
• Stay current with international and domestic regulatory requirements and best practices
• Provide guidance on interpreting and implementing regulations, guidelines, company procedures, and working practices
Requirements:
• BS or MS in a scientific field (e.g. Chemistry 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 within regulatory
• Experience managing and compiling Module 3 documentation
• Expertise in CMC lifecycle management for drug substance and drug product
• Solid understanding of US, EU, and Canada regulations, guidelines and regulatory processes for development and lifecycle maintenance
• Experience working within Veeva RIM system is preferred.
Benefits:
• Merit-based salary increases
• Short incentive plan participation
• Eligibility for 401(k) plan
• Medical, dental, vision, life and disability insurances
• Robust time-off policy including flexible paid time off
• 11 paid holidays plus additional time off for shut-down period during the last week of December
• 80 hours of paid sick time upon hire and each year thereafter