Regeneron · 1 day ago
Director, Regulatory Affairs Strategy - Oncology
Tarrytown, NY
Full-time
Onsite
Director/Executive
$205K/yr - $342K/yr
10+ years expRegeneron is a leading biotechnology company, and they are seeking a Director of Regulatory Affairs to provide leadership on global regulatory activities for oncology products. The role involves overseeing clinical regulatory filings, leading project teams, and ensuring compliance with regulatory requirements.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Provide interpretation of regulatory authorities’ feedback, policies and guidelines
Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation of major clinical submissions required for regulatory approval
Work with project teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure attainment of governmental approvals
Responsible for quality and timeliness of IND/CTA and BLA submissions. Interact with other functions and partners, in the preparation, review, and completion of documents for regulatory submissions
Successfully plan, prioritize, supervise and/or conduct activities in close collaboration with leads from other areas. Assure compliance with regulations and with project team timelines
Provide interpersonal support and lead personnel
Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams
Qualification
Required
MD, Ph.D. or Pharm D. degree
Minimum of 10 years of pharmaceutical industry experience
At least 7 years of regulatory experience
Excellent written and verbal communication skills
Strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices
Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams
Preferred
Experience interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations
High attention to detail; ability to coordinate and prioritize assigned projects according to company goals
Strong interpersonal skills both written and verbally
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
Pharmaceutical Technology
2026-01-16
2026-01-16
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