Director/Senior Directior of Regulatory Affairs - Barrington James

  • Barrington James
  • 130 E Washington St, North Attleboro, MA 02760
  • Full-Time



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Looking to bring on a Director/Senior Director of CMC. The ideal candidate will have the following experience and background:

Relocation Assistance: Offered

Responsibilities:

Responsible for the management and tactical execution of the regulatory CMC activities and ensuring that all applicable CMC-related regulations and guidelines are followed in the US and globally.

Perform regulatory assessment of change controls, deviations and GMP investigations. Manage multiple concurrent projects and provide project updates on set intervals.

Assist with the planning, scientific writing and perform critical reviews of pre-INDs, INDs, IMPDs, NDAs, MAAs, annual reports, DSUR, amendments, supplements to ensure a high quality regulatory submission and approval.

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.

Participate, as needed, in planning, organizing and managing the CMC content of meetings with regulatory agencies.

Experience:

  • At least 7+ years of regulatory CMC experience.
  • Experience with Regulatory Strategy.
  • Experience with IND and NDA submissions.
  • Product launch experience, and ability to liaise with FDA and other regulating bodies.
  • If you believe the above qualifications fit your skills and background, you are highly encouraged to apply!

    Thanks.

    ...@Barringtonjames.com



    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.