CMC Regulatory Affairs Specialist
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Tarrytown, New York
- Start date
- Jan 24, 2023
View more
- Discipline
- Clinical, Clinical Medicine, Science/R&D, CMC
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
The Senior Regulatory Affairs (RA) CMC Compliance Specialist performs CMC RA assessment of changes and deviations, performing initial triage and coordination of the relevant assessment in conjunction with RA CMC program assessment teams. Work closely with IOPS colleagues to support evaluation of changes and deviations and assigning regulatory actions as needed. Evaluates the efficiency of system for regulatory assessment of change controls and deviations and improves them continuously evaluating.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Coordinate the review of internal multiproduct change controls, consolidating the evaluation of regulatory impact from each product.
- Provides representative at cross functional change review boards
- Handle timelines regarding review of change controls in collaboration with Supply Chain(IOPS) colleagues to ensure timely review of change controls and remediation of identified deviations
- Perform review of change controls relating to component and non-component raw material, manufacturing, analytical testing, and labeling to resolve regulatory impact and associated submission requirement for clinical and commercial regulatory filings in accordance with country specific regulatory mentorship documents..
- Coordinate the review of Partner Notification forms and inter-company change controls for multi-product change controls, consolidating the evaluation of regulatory impact for each product
- Bachelor’s degree in a relevant technical, scientific field required and 5+ years of relevant experience is in CMC change evaluation for the US and EU.
- Experience with Process Compliance/QUMAS heavily preferred.
Salary Range (annually)
$74,300.00 - $121,300.00Company
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
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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