Manager, Regulatory Affairs Strategy - Oncology

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 to the GRL 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/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.

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

• Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including INDs/CTAs, amendments and information requests, orphan drug applications, annual reports and investigator’s brochure.
• Assist in coordination and preparation for Agency meetings and associated briefing document preparation.
• Lead and track queries and commitments with regulatory agencies, collaborate with subject matter experts to provide written responses to queries, provide periodic status updates regarding conditions/commitments.
• Provide representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings.

• Minimum MD, PhD or PharmD degree along with 2+ years of regulatory experience.
• Experience working on filings, helping with developing regulatory related documents and engaging with external partners and authorities.
• Good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
• Experience interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred.
• High attention to detail; ability to coordinate and prioritize assigned projects according to company goals.
• Strong interpersonal skills both written and verbally.

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.

Regeneron offers a competitive and comprehensive total rewards package which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g., medical, dental, vision, life and disability), paid time off, and family support benefits.

Salary Range (annually): $ - $