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Manager, Regulatory Affairs

Employer
Regeneron Pharmaceuticals, Inc.
Location
Basking Ridge, New Jersey
Start date
Sep 29, 2022

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

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.

Job Duties

A typical day might include the following:

  • 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 Investigator’s 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

Job Requirements

This role might be for you:

  • 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

To be considered for this opportunity, we expect you must have a 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.

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 parental 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.

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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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