Director/Sr. Director CMC Regulatory Affairs

Found in: Jooble US O C2 - 2 weeks ago

Los Angeles CA, United States BioPhase Solutions Full time
Job Description

Job Description

BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Director/Sr. Director, CMC Regulatory Affairs to work for a leading Greater Los Angeles area biotechnology company.

The Director/Sr. Director, CMC Regulatory Affairs is responsible for development and lead of the CMC regulatory strategy for early-stage T-cell therapies. These capabilities may include but are not limited to developing CMC regulatory strategy, providing internal CMC regulatory guidance, and interaction with regulatory agencies.

Salary: $175-250k depending on experience

Responsibilities:

  • Interpret global regulations and guidance to identify risks and provide strategic guidance to cross functional product teams.
  • Develop CMC regulatory strategy for early-stage cell therapy products through late stage and product registration.
  • Represent CMC regulatory affairs on product teams and in health authority interactions.
  • Lead development and compilation of Quality modules for global regulatory submissions including but not limited to clinical trial applications, health authority responses and briefing packages.
  • Ensures that submission documents and correspondence are of the highest quality in terms of content, organization, clarity, and accuracy.
  • Lead the build out CMC regulatory organization to support expanding cell therapy pipeline.
  • Serve as a strong partner to the Development and TechOps organizations.
  • Perform other duties as required.
  • Hire, lead, managing workflow and develop of staff.
  • Demonstrated ability to develop/maintain strong working relationships with the cross functional teams, participate on and/or lead multi-functional teams, manage/prioritize multiple projects, and work independently.
  • Advanced leadership skills to successfully lead complex programs. Able to effectively build and lead high-functioning teams.
  • Outstanding organizational skills with the ability to multi-task and prioritize.

Requirements:

  • BA/BS degree in life sciences required
  • 8-10 years of experience in CMC Regulatory Affairs
    • Experience in cell therapy preferred
  • Knowledge of global CMC regulations
  • Experience leading CMC teams in IND, IMPD, BLA, MAA filings

Please send resumes to gavin@biophaseinc.com and visit our website at for additional job opportunities

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