Associate Manager, CMC Regulatory Affairs
- Regeneron Pharmaceuticals, Inc.
- Tarrytown, New York
- Start date
- Mar 23, 2023
- Regulatory, Regulatory Affairs, Science/R&D, CMC
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Pharm Country, Best Places to Work
An Associate Manager of CMC Regulatory Affairs will perform review of all changes including raw materials, components, manufacturing, facilities, analytical testing, and labeling to resolve regulatory impact and associated submission requirement for clinical and commercial regulatory filings, in accordance with country specific regulatory guidance documents.A typical day will include the following:
Represent CMC RA at cross functional review boards
Coordinate the internal change controls evaluations affecting single to multiple products
Handle the timelines agreed with IOPS for urgent and non-urgent change controls
Chip in to the assessment of internal Change Controls provided by suppliers of materials/component/testing services, CMOs, and Partners
Contribute to the assessment of internal deviations
Continue to evaluate processes and identify areas of improvement
Provide training and support to new team members on platforms, tools and systems related to the role
Mentor and provide support to new team members in learning how to perform regulatory assessments
You have an understanding of CMC RA regulations
You have a proven record of supporting biologics through development and approval
You have experience delivering CMC/CP sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for biologics / combination products
You have engaged with FDA and other regulatory authorities
To be considered for this opportunity you must have at a minimum a Bachelors Degree within a scientific field and 4+ years of Regulatory CMC Affairs experience. This is a hybrid role, requiring to be on-site 2 times a week and 3 days work-from-home.
#LI-HybridDoes 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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)$74,300.00 - $121,300.00
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
- Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
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