Director, CMC Regulatory Affairs - Rensselaer, NY | Biospace
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Director, CMC Regulatory Affairs

Regeneron Pharmaceuticals, Inc.

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Location:
Rensselaer, NY
Posted Date:
9/26/2017
Position Type:
Full time
Job Code:
6808BR
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.

Summary: Maintain active engagement with emerging and current regulatory trends in the industry and act in a consultative capacity to the Industrial Operations and Product Supply division and clinical regulatory affairs as related decisions and processes are executed. Support all CMC regulatory filing activities for various pre-INDs, INDs, IMPDs, CTAs and BLAs/MAAs and track regulatory commitments.

Essential Duties and Responsibilities include, but are not limited to, the following:

  • Manage timelines in cooperation with project management, SMEs and Regulatory Operations (Reg Ops) to ensure on-time regulatory submissions.
  • Assist with the planning, scientific writing and perform critical reviews of pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, DSUR, amendments, supplements to ensure a high quality regulatory submission and approval
  • Ensure that all regulatory submissions are of highest regulatory standards.
  • Coordinate and manage regulatory inspections, as needed, at the Rensselaer site or at other sites if the inspection relates to regulatory CMC issues.
  • Assist in review of manufacturing change controls by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and BLAs/MAAs and to ensure that CMC related changes are reported to competent authorities in accordance with regulatory requirements.
  • Support establishing, managing and maintaining a knowledge base of current and emerging regulatory requirements and guidelines in the CMC field.
  • Assist in tracking of CMC regulatory commitments for INDs/IMPDs, CTAs, and BLAs/MAAs.
  • Participate, as needed, in planning, organizing and managing the CMC component of pre-IND, pre-BLA and other Type C meetings with the FDA.
  • Support IOPS by providing CMC related guidances so that their short-term and long-term goals are achieved on time and with highest quality.
  • Participate in CMC project team meetings and provide current regulatory requirements that pertain to stability studies and analytical characterization tests.

Requirements

Requires a degree in a science related discipline and a minimum of 12 years pharmaceutical industry experience with 8 years of relevant CMC biotech/pharmaceutical industry experience.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.