Director, Regulatory Affairs - Oncology
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Tarrytown, NY, United States
- Start date
- Apr 7, 2021
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- Discipline
- Regulatory, Regulatory Affairs, Science/R&D, Oncology
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
In this role, a typical day might include the following:
- This role requires the ability to integrate and apply knowledge of global regulations governing pharmaceutical drug development of all aspects of Regeneron's quality, preclinical and clinical drug development programs, policies and procedures, so that Development teams can meet all objectives within specified timelines and so that the state of compliance is maintained to all regulatory commitments/requirements.
- Develop regulatory strategies for assigned oncology programs in collaboration with Regeneron's Regulatory senior management.
- Provide regulatory analysis, guidance and assessment of drug(s) developed for similar indication to obtain approval of activities in support of Regeneron's development and marketing objectives within targeted timelines.
- In charge of communication with FDA and health authorities for assigned oncology programs.
- Manage and lead regulatory activities associated with Regeneron assigned oncology drug development programs.
- Oversee the planning, preparation and submission of licensing applications (BLA/MAA).
- Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs.
- Provide training on applicable requirements for scientific staff as the need arises.
- Manage and mentor direct team members and/or junior staff.
MD, PhD or Pharm D required
Minimum 4-5 years experience in oncology regulatory affairs required
Must possess excellent written, verbal communication and presentation skills
#LI-ET1
Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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