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Manager CMC/CP Regulatory Affairs

Regeneron Pharmaceuticals, Inc.
Basking Ridge, New Jersey
Start date
May 17, 2024

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Job Details

The candidate will support the development and execution of regulatory strategies for biologic products and combination products for the portfolio assigned and perform the duties outlined below

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

Support CMC/Combination product development activities from a regulatory standpoint during early phase, development, submissions and post market requirements
Participate in IOPS cross-functional meetings for program-specific discussions, connect the dots across IOPS, proactively identify CMC regulatory issues and suggest appropriate strategies to mitigate or fix them, translates ambiguity into actional steps. Ensure appropriate communications between IOPS and global RA in a timely manner
Review the content and format of regulatory filing documents (e.g. pre-INDs, INDs, IMPDs, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements, scientific advice) to ensure compliance with applicable regulations and guidelines governing the development, licensure, and marketing of drugs and/or biologics
Participate in global RA meetings and help to develop regulatory strategies to support CMC/CP activities. Participation in communications between Global RA and IOPS as needed

This role may be for you if have:

Need to have good understanding of current CMC RA worldwide regulations
Experience in delivering CMC/CP sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for biologic products / combination products
Experience in dealings with FDA and other regulatory authorities is an advantage

To be considered for this opportunity we are looking for:

Bachelors degree in a relevant technical, scientific field required; advanced degree is an advantage
A minimum of 6 years (BS/BA) or 4 years (advanced degree) pharmaceutical/biotech proven experience including a 2 - 4 years of relevant CMC experience

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$104,300.00 - $170,100.00


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
Corporate Headquarters
777 Old Saw Mill River Road
New York

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