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Sr CMC Regulatory Affairs Specialist

Employer
Regeneron Pharmaceuticals, Inc.
Location
Troy, New York
Start date
Nov 27, 2021

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

Act as the CMC Regulatory Affairs representative for a subset of programs at the IOPS facility. Evaluate proposed changes to IOPS documents and procedures to determine regulatory impact.

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

* Plans and conducts critical reviews of pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, DSUR, amendments, and supplements to ensure a high quality regulatory submission and approval

* Reviews Change Controls by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and BLAs/MAAs and ensures that CMC related changes are reported to competent authorities in accordance with regulatory requirements, as necessary

* Reviews all deviations and provides regulatory assessments to support IOPS

* Provides assistance to CMC Regulatory Affairs management in preparing meeting requests, briefing books, and responses to information requests received from various Health agencies.

* Tracks and/or completes CMC regulatory commitments for INDs/IMPDs, CTAs, and BLAs/MAAs

* Provides CMC-related guidance to IOPS so that their short-term and long-term goals are achieved on time and with highest quality

* Participates in CMC project team meetings and provides current regulatory requirements that pertain to stability studies and analytical characterization tests

This role might be for you if:

Two to five years of relevant experience in biotech/pharmaceutical industry.

Advanced degree in lieu of experience will also be considered.

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.

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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