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    Director/Sr. Director CMC Regulatory Affairs - Los Angeles, United States - BioPhase Solutions

    BioPhase Solutions
    BioPhase Solutions Los Angeles, United States

    2 weeks ago

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    Description

    Job Description

    Job DescriptionBioPhaseSolutions 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 and visit our website at for additional job opportunities

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