Manager, Regulatory Affairs Strategy - Oncology

Regeneron Pharmaceuticals, Inc (USA); Kentucky; Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Competitive total rewards package

Health and wellness programs

Job summary

Regeneron Pharmaceuticals, Inc. in the United States seeks a Manager to join the Regulatory Affairs Strategy Oncology team.

You will coordinate preparation, submission, and maintenance of global regulatory submissions and assist in agency meetings and briefing documents. This role requires an MD, PhD, or PharmD with 2+ years of regulatory experience, experience with US FDA and international guidelines, and strong written and verbal communication.

Qualifications

• MD/PhD/PharmD with 2+ years regulatory experience.
• Experience with filings and preparing regulatory documents.
• Knowledge of US FDA and international guidance and drug development process.

Responsibilities

• Coordinate the preparation, submission, management, and maintenance of global regulatory submissions (INDs/CTAs, amendments, information requests, Orphan drug applications, Annual Reports, Investigator’s Brochures).
• Assist in coordination and preparation for agency meetings and briefing documents.
• Lead and track queries and commitments with regulatory agencies, providing written responses and status updates.
• Represent study-level regulatory activities and participate in cross-functional projects/meetings.

Skills

Regulatory affairs experience

FDA/regulatory guidelines

Communication skills

Education

MD/PhD/PharmD

Job description

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager to join our Regulatory Affairs Strategy Oncology team.

The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provide support in all aspects of regulatory affairs related to the development of novel therapeutics, including quality, preclinical, and clinical areas of drug development, and the policies and procedures required to ensure compliance with regulations.

Work Location: Tarrytown, NY or Warren, NJ. Hybrid; 4 days per week on site.

Discover your role:

• Coordinate the preparation, submission, management, and maintenance of global regulatory submissions related to clinical and non‑clinical aspects of product development (e.g., INDs/CTAs, amendments, information requests, Orphan drug applications, Annual Reports, and Investigator’s Brochures).
• Assist in coordination and preparation for agency meetings and associated briefing documents.
• Lead and track queries and commitments with regulatory agencies, collaborating with subject‑matter experts to provide written responses and periodic status updates on conditions and commitments.
• Provide representation for study‑level regulatory activities and participate in cross‑functional departmental team projects and product development activities/meetings.

This role requires:

• Minimum MD, PhD, or PharmD degree with 2+ years of regulatory experience.
• Experience with filings, developing regulatory documents, and engaging with external partners and authorities.
• Strong understanding of US FDA and international guidance, regulations, drug development process, and industry standard practices.
• Experience interacting with CROs in managing ex‑US/ex‑EU CTAs towards clinical trial activations (preferred).
• High attention to detail and ability to coordinate and prioritize assigned projects according to company goals.
• Strong written and verbal interpersonal skills.

Benefits:

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

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.