Sr. Manager, CMC Regulatory Affairs

Location
Rensselaer, NY, United States
Posted
Sep 17, 2019
Ref
17599BR
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:
Develop and execute worldwide CMC regulatory strategies for investigational and commercial products. Also perform RA-CMC compliance activities to support IOPS organization.

Responsibilities:

• Create and execute regulatory strategies for worldwide investigational and registrational submissions, e.g., IND, IMPD, BLA, MAA, NDS, Japaneese NDA, etc.

• Assist with planning, scientific writing and performing critical reviews of pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, DSUR, amendments, supplements in eCTD format to ensure a high quality regulatory submission and approval.

• Assist in the preparation of eCTD sections for post approval submissions like CBE 0, CBE 30, PAS for the U.S. and Types I and II Variations for Europe.

• Be a CMC liaison with Health Authorities worldwide.

• Be part of the project teams and provide regulatory CMC guidances on critical issues.

• Manage timelines in cooperation with project management, IOPS/Tarrytown SMEs and Tarrytown Regulatory Operations (RegOps) to ensure on-time regulatory submissions with highest quality.

• Assist in review of IOPS change controls by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and BLAs/MAAs and ensure that manufacturing and analytical changes are reported to the competent authorities in accordance with the current regulatory requirements.

• Perform regulatory release for investigational products.

• Evaluate manufacturing deviations and propose proper regulatory implications.

• Assist in tracking regulatory commitments in INDs, IMPDs, CTAs and BLAs/MAAs.

• Participate in planning, organizing and managing the CMC component of meetings with the FDA and other regulatory bodies.

Requirements:
Requires a BS or MS degree in a scientific displine with a minimum of 8 years of experience in Biotech and/or Pharmaceutical CMC area.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.