Manager, Regulatory Affairs Strategy - Oncology Employer Regeneron Pharmaceuticals, Inc. Location Warren, New Jersey Start date Jul 22, 2026 View more categories View less categories Discipline Marketing , Regulatory , Science/R D , Oncology Required Education Doctorate/PHD/MD Position Type Full time Hotbed Pharm Country , Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details 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 provides 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. When & where:

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 nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigators Brochure Assist in coordination and preparation for Agency meetings and associated briefing document preparation Leads and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides 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 This role requires: Minimum MD, PhD or PharmD degree along with 2+ years of regulatory experience. We expect to see individuals have worked on filings, helped with developing regulatory related documents and engaged with external partners and authorities. If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices. If you are interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred If you have a high attention to detail; ability to coordinate and prioritize assigned projects according to company goals You bring strong interpersonal skills both written and verbally Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter. Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location. As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications. For jobs in

Canada:

this posting is for an existing position. Salary Range (annually) $128,600.00 - $210,000.00 Company Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Stock Symbol:

REGN Stock Exchange:

NASDAQ Company info Website https://www.regeneron.com/ Phone 914-847-7000 Location Corporate Headquarters 777 Old Saw Mill River Road Tarrytown New York 10591 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Senior Research Associate, Analytical Development Tokyo - Japan Scientific Affairs Manager ( Biologics) Rockville, MD Senior Manager, Regional Regulatory Lead - North America, Seqirus Vaccines Holly Springs, NC