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Job

Senior Director, Regulatory Affairs - CMC Biologics

  • Location

    Massachusetts

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Tim Viola

  • Contact email:

    t.viola@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    3 months ago

  • Expiry date:

    2022-03-31

  • Startdate:

    ASAP

Director/Senior Director, Regulatory Affairs - CMC Biologics

*Fully Remote on East Coast, or Central Time Zone*

Responsibilities:

  • Serve as a CMC Regulatory Lead. Provide CMC regulatory leadership within Regulatory and on cross-functional teams.
  • Uses knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support goals
  • Lead CMC related interactions with regulatory agencies.
  • Coordinate and author/review high-quality CMC submissions to regulatory agencies, including INDs, CTAs, IMPDs, NDAs/BLAs, MAAs, amendments, and briefing documents for Health Authority meetings as well as other relevant CMC documents.
  • Collaborate with internal teams, consultants, QA colleagues, and CROs/CMOs to document and resolve technical manufacturing issues.
  • Develop and execute global CMC regulatory strategies for investigational drugs/biologics in oncology.
  • Maintain knowledge of global CMC regulatory requirements to advise teams on regulations, guidelines, procedures and policies relating to development, registration, and manufacture of new biopharmaceuticals products, to expedite the submission, review and approval of global CMC applications.

Qualifications:

  • Master’s degree or PhD (preferred) in chemistry, biochemistry, or pharmacy with a minimum of 6 to 8 years of experience in global CMC Regulatory Affairs in the pharmaceutical/biotech industry, supporting both development projects and marketed products with evidence of successful CMC submissions (e.g. INDs, NDAs/BLAs, briefing packages)
  • Knowledge of FDA and ICH CMC regulations and guidelines, EU and other regional CMC regulations desirable
  • Strong knowledge of eCTD elements and structure
  • Experience in oncology is strongly preferred. Knowledge of Antibody-Drug Conjugates (ADCs) and combination products is a plus.

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