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Director CMC Regulatory Affairs

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, New York
Start date
Sep 22, 2022

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Job Details

The Director, CMC Regulatory Affairs Non-antibody Team will manage the Manufacturing and Controls (CMC) & Combination Products (CP) Non-antibody team. We expect the Director to be responsible for assuring development and execution of global strategies for the Non-antibody drug/device portfolio. The Director will lead all aspects of regulatory affairs staff, contractors, supporting project teams and development partners and leading Health Authority activities.

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

  • Direct activities of assigned Regulatory Affairs team with emphasis on global regulatory strategy and the preparation, review, and submission of documents for FDA.
  • Drive strategic and operational global CMC/CP regulatory direction and documentation for portfolio covering initial registrations and approval/post approval activities.
  • Implement appropriate regulatory strategies to mitigate risks to filings.
  • Lead strategy on regulatory filling documents. Final reviewer on all global program submissions for the portfolio to ensure alignment with program regulatory strategy & development plan.
  • Provides oversight of activities, including team preparation, for meetings with Health Authorities
  • Provide support for compliance and inspection-related activities for non-antibody products.

This role might be for you if:

You have a track record of supporting monoclonal antibody or non-antibody products through development and approval.

You have good understanding of current CMC / Combination Product worldwide regulations

You have proven leadership in delivering CMC/CP sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for biologic products / combination products.

You have Bachelor’s degree in a relevant technical, scientific field required; advanced degree strongly preferred

You have 10 years pharmaceutical/biotech industry experience including a minimum of 5 years of relevant CMC experience including experience in the recombinant technology (antibody/ non-antibody) field or master’s degree with 8+ or PhD with 3+ years working.

You managed individuals previously

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

#GDRAJobs

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