Director CMC Regulatory Affairs

Regeneron Pharmaceuticals • Warren, MI

32d • Onsite

About The Position

Leads the Chemistry, Manufacturing, and Controls (CMC) & Combination Products (CP) Internal Medicine team. The candidate will be responsible for the development and execution of global regulatory strategies for the assigned drug/device portfolio. This role involves overseeing regulatory affairs staff, various outside contractors, supporting project teams and development partners, and leading activities with the Health Authority. A typical day might include: Oversee the assigned CMC/CP Regulatory Affairs team, driving global regulatory strategies and operational direction for the assigned portfolio, including initial clinical registrations, market application approvals, and post-approval lifecycle management. Lead the preparation, review, and submission of regulatory documents (e.g., meeting packages/briefing book, scientific advice, BLAs, MAAs, BPDRs, supplements) to regulatory authorities. Provide scientific and regulatory inputs for the assigned portfolio to facilitate and expedite the development and marketing of drugs and/or biologics. Oversee and direct interactions with global regulatory authorities, including meetings, information request responses, and inspections. Direct and provide advice on the compliance activities (e.g., change controls, deviations) for the assigned portfolio, evaluating regulatory impacts and associated submission requirements for clinical and commercial regulatory filings in accordance with country-specific guidelines. Develop and implement department objectives and work plans, delegate responsibility effectively, and prioritize team workloads to meet organizational goals. Provide leadership by contributing to departmental strategy, organizational goals, and policy development. Guide team members to address complex and unprecedented program challenges, ensuring timely resolution. Participate in cross-functional groups and working groups to improve current practices and establish new processes/procedures

Requirements

• A bachelor’s degree with a minimum of 10 years of pharmaceutical/biotech industry experience, including a minimum of 8 years of relevant CMC experience. Alternatively, a master’s degree with 8+ years of experience, or a PhD degree with 3+ years of experience.
• At least 3 years of applicable managerial experience.

Nice To Haves

• Proven track record of supporting biological products and/or small molecule drugs through development and approval is a distinct advantage.
• Strong understanding of current CMC / CP worldwide regulations.
• Successful leadership in delivering CMC/CP sections of marketing authorizations, clinical trial applications (CTA/IND), and post-approval submissions for biological products, combination products, and/or small molecule drugs.
• Previous experience with device regulatory requirements and development processes for combination products is an advantage.
• Human Factors experience is a plus.
• Experience in dealings with the FDA and other regulatory authorities.
• Experience managing and developing staff members.

Responsibilities

• Oversee the assigned CMC/CP Regulatory Affairs team, driving global regulatory strategies and operational direction for the assigned portfolio, including initial clinical registrations, market application approvals, and post-approval lifecycle management.
• Lead the preparation, review, and submission of regulatory documents (e.g., meeting packages/briefing book, scientific advice, BLAs, MAAs, BPDRs, supplements) to regulatory authorities.
• Provide scientific and regulatory inputs for the assigned portfolio to facilitate and expedite the development and marketing of drugs and/or biologics.
• Oversee and direct interactions with global regulatory authorities, including meetings, information request responses, and inspections.
• Direct and provide advice on the compliance activities (e.g., change controls, deviations) for the assigned portfolio, evaluating regulatory impacts and associated submission requirements for clinical and commercial regulatory filings in accordance with country-specific guidelines.
• Develop and implement department objectives and work plans, delegate responsibility effectively, and prioritize team workloads to meet organizational goals.
• Provide leadership by contributing to departmental strategy, organizational goals, and policy development.
• Guide team members to address complex and unprecedented program challenges, ensuring timely resolution.
• Participate in cross-functional groups and working groups to improve current practices and establish new processes/procedures

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees