Manager, Regulatory Affairs Strategy - Oncology

About the role

Regeneron is seeking a Manager to join the Regulatory Affairs Strategy Oncology team. The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and support the GRL in all aspects of regulatory affairs related to the development of novel therapeutics, including quality, pre‑clinical, and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations. This position offers the opportunity to contribute to a fast‑growing, science‑driven organization making a meaningful difference to patients worldwide.

Responsibilities

• Coordinate the preparation, submission, management, and maintenance of global regulatory submissions related to clinical and non‑clinical product development (e.g., INDs/CTAs, amendments, information requests, orphan drug applications, annual reports, investigators’ brochures).
• Assist in coordination and preparation for agency meetings, including briefing document preparation.
• Lead and track queries and commitments with regulatory agencies; collaborate with subject‑matter experts to provide written responses and periodic status updates.
• Provide representation for study‑level regulatory activities.
• Participate in cross‑functional departmental team projects and product development meetings.

Requirements

• Minimum MD, PhD, or PharmD degree.
• At least 2 years of regulatory experience, including work on filings and development of regulatory documents.
• Experience engaging with external partners and regulatory authorities.
• Strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development processes, and industry best practices.
• Preferred experience interacting with CROs to manage ex‑US/ex‑EU CTAs for clinical trial activations.
• High attention to detail and ability to coordinate and prioritize projects according to company goals.
• Strong interpersonal skills, both written and verbal.

Benefits

• Competitive total rewards package, which may include annual bonuses or other incentive plans and equity awards.
• Pension or retirement benefits, including 401(k) company match.
• Health and wellness programs, fitness centers, and comprehensive insurance benefits (medical, dental, vision, life, and disability).
• Paid time off and family support benefits.

Pay

Salary range (annually) $128,600 – $210,000 (Canada). The final offer will be determined within the relevant range based on country of employment, specific role level, and the candidate’s skills and experience.

Schedule

Work location: Tarrytown, NY or Warren, NJ. Expected on‑site presence: 4 days per week.