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Manager CMC Regulatory Sciences

Employer
Regeneron Pharmaceuticals, Inc.
Location
Troy, New York
Start date
Sep 20, 2022

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Job Details

We are currently looking to fill a CMC Regulatory Sciences Manager position. The manager is responsible for overseeing a team of people preparing chemistry, manufacturing and controls (CMC) submissions. This role will be responsible for onboarding and developing new specialists in the submissions groups and will work collaboratively with program leads to assign staff according to business priorities.           

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

  • Managing and developing CMC-RS staff/direct reports with a focus on submission writing support
  • Oversees the completion of CMC-RS submission projects, manages workload, and provides direction to CMC-RS Specialists and/or other CMC-RS staff.
  • Collaborates with project teams to manage and coordinate activities related to the preparation and finalization of CMC documents in accordance with established timelines, keeping all team members informed of progress and bringing up risks as necessary.
  • Oversees submission document improvement efforts based on industry trends and business needs
  • Oversees a team of specialists who may be assigned to assist with the timely and accurate assembly of responses to inquiries from Regulatory agencies on the content of CMC documents, when applicable.
  • Reviews and approves CMC submission content, ensuring content is aligned with established CMC strategies and that documents are prepared according to established internal procedures
  • Reviews and approves ancillary CMC documents and reports for completeness and accuracy and for compliance with regulations.
  • Identifies project issues and contributes to development of alternate strategies related to CMC submission content.
  • Applies understanding of regulatory guidance and regulations and industry standard processes to continuous improvement of submission writing and processes
  • Keeps management informed of decisions, overall strategy and project status.

This role may be for you if you:

  • demonstrated experience writing a wide range of eCTD (Quality – Module 3) documents.
  • coaching and leadership experience required
  • strong skills in developing and implementing business processes
  • demonstrated experience working with cross-functional teams on CMC submission content development and continuous improvements

To be considered for this role you must hold: BS/BA degree in Chemistry, Biology or related field, with relevant experience or equivalent combination of education and experience, preferably pharmaceutical or medical device, including some supervisory and/or leadership experience.

  • Associate Manager: Requires 6+ years of relevant experience
  • Manager: Requires 7+ years of relevant experience

Level is determined based on qualifications relevant to the role.

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 eligible 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 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.

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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