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Assoc Dir Regulatory Affairs

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, New York
Start date
Sep 22, 2021

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

You need to have the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development. You will interact with all aspects of Regeneron's quality, preclinical, and clinical drug development programs, policies, and procedures. This is vital so the development teams are able to meet all objectives within agreed timelines ensuring compliance is maintained with all regulatory commitments/requirements.

In this role, a typical day might include the following:

Act as liaison between company and FDA and other health authorities for assigned programs

Develop regulatory strategies for assigned programs, in order to support Regeneron’s development and marketing objectives. This will be achieved through analysis of guidances and assessment of other drugs, and in collaboration with Regeneron's senior regulatory management.

Management of activities associated with Regeneron development programs.

We expect that you will participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals.

Provide mentorship to multidisciplinary teams on the content, format, style and architecture of an Investigational New Drug (IND) application or CTA for ex-US studies. Edit or lead the editing of scientific sections of regulatory documentation against the regulatory requirements. Assist with the writing, review and preparation of an IND application. Manage the organization, preparation and review of IND amendments, annual reports and other regulatory documents and correspondence.

Perform/lead critical analyses of data (clinical, preclinical and manufacturing), independently developing interpretations and conclusions.

Perform reviews of clinical protocols and study reports to focus attention on deficient/missing items/explanations.

Accountable for ensuring the completeness and accuracy of all regulatory submissions.

Supervisory responsibility for the planning, preparation and submission of regulatory documentation.

Management of the planning, preparation and submission process for licensing applications.

Provide guidance/instruction to multidisciplinary teams on the content, format, style architecture and timing of a Biologics Licensing Application (BLA) or MAA and the subsequent regulatory review process.

Assist with the scientific writing and review of a BLA and evaluate conformance with the regulatory requirements.

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 required.

This role might be for you if:
  • We require an MD, Ph.D or PharmD
  • Expert knowledge of regional health authority regulations and advanced knowledge of global regulations
  • Demonstrated interactions with local health authorities
  • Excellent communication skills and strong analytical skills
  • Demonstrated leadership and project management skills, including cross-functional communication
  • We desire at least 5+ years of RA experience.

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

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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