Associate Director, Regulatory CMC
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Rensselaer, NY, United States
- Start date
- Apr 18, 2021
View more
- Discipline
- Regulatory, Regulatory Affairs, Science/R&D, CMC
- Required Education
- Other
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
In this role, a typical day might include the following:
- Responsible for managing activities of assigned Regulatory Affairs CMC team with emphasis on global regulatory strategy and the preparation, review and submission of documents for FDA and other regulatory authorities
- Supports the regulatory function on assigned development/commercial programs providing CMC regulatory guidance and strategy including identifying and assessing regulatory risks
- Critically review and provide strategy input on regulatory filling documents (e.g. pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, DSUR, amendments, supplements).
- Lead and facilities activities, including team preparation, for meetings with FDA and other regulatory authorities for CMC development activities
- Liaison responsible for communication with FDA and other regulatory authorities for assigned programs
- Proactively identify program issues and develop appropriate regulatory strategies to mitigate risks
- Perform RA-CMC compliance activities to support IOPS organization.
- Coordinate and lead regulatory inspections, as needed, at the Rensselaer site or at other sites if the inspection relates to regulatory CMC issues.
- Montior emerging legislation and guidance in the CMC field and contribute to ensuring company-level awareness and compliance (where appropriate).
- Lead and mentor direct reports and/or junior staff members
Need to have good understanding of current CMC RA worldwide regulations.
Proven track record of supporting biological product through development and approval is a distinct advantage
Experience managing and developing staff members essential
Experience in dealings with FDA and other regulatory authorities
Strong communication and negotiation skills
We expect you to build collaboration and teamwork across cross functional teams
Demonstrated skill in managing multiple priorities
We seek a minimum of 10 years pharmaceutical/biotech industry experience including a minimum of 5 years of relevant CMC experience
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
- 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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