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CMC Regulatory Sciences Specialist

Employer
Regeneron Pharmaceuticals, Inc.
Location
Troy, New York
Start date
Sep 7, 2021

View more

Discipline
Clinical, Clinical Medicine, Science/R&D, CMC
Required Education
Bachelors Degree
Position Type
Contract
Hotbed
Pharm Country, Best Places to Work

Job Details

The CMC Regulatory Sciences Specialist gathers and interprets data associated with the preparation of product quality reviews (PQR). We are looking for someone to effectively drive the information outlined in procedures, regulations, and guidance documents for the preparation of product quality reviews and other documents.

As the CMC Regulatory Sciences Specialist, a typical day might include the following:

  • Reviewing manufacturing data to conduct timely product quality reviews while assessing quality-related information to detect trends
  • Collaborating with manufacturing and quality personnel in monitoring the manufacturing process as well as preparing and reviewing documents
  • Updating various sources of information into a uniform style and language for regulatory compliance
  • Communicating PQR data to senior management, regulatory agencies, and business partners and corresponding with global business partners and contract manufacturing organization
  • Supporting other teams in CMC Regulatory Sciences department with the preparation of regulatory documents to support all phases of drug development
  • Identifying project or resource constraints and chips into the development of alternate strategies
  • Potentially supervising and assigning projects to other specialists

This role might be for you if:

  • You have strong written and verbal communication skills
  • You can work independently, prioritize, coordinate and complete multiple projects while maintaining a high level of attention to detail
  • You are passionate about drug development and Regeneron’s mission, including The Regeneron Way

To be considered for the Associate Specialist role you must have a BS/BA of equivalent combination of education and experience. For the Specialist role, you must have a BS/BA with 2 years of relevant experience or 5 years of experience as a Senior Specialist. A degree in a scientific field is preferred. We want someone who is proficient in creating databases and organizing/visualizing data as well as quality assurance, regulatory, or biopharma manufacturing experience. Experience with pharmaceutical quality systems is highly desirable.

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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