Regeneron · 2 weeks ago
Director CMC Regulatory Affairs
Troy, NY
Full-time
Onsite
Director/Executive
$172K/yr - $287K/yr
8+ years expRegeneron is a leading biotechnology company focused on developing life-transforming medicines. The Director of CMC Regulatory Affairs will lead the CMC & Combination Products team, overseeing regulatory strategies and ensuring compliance with global regulations for the drug/device portfolio.
BiopharmaBiotechnologyPharmaceutical
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
Qualification
Required
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
Preferred
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
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)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
2026-01-09
2026-01-08
Company data provided by crunchbase