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    Associate Director Regulatory Affairs - San Francisco, United States - Life Science People

    Life Science People
    Life Science People San Francisco, United States

    1 week ago

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    Description
    Associate Director, Regulatory Affairs


    HYBRID:
    South San Francisco, CA


    Working with one of my key clients, a clinical-stage biotechnology company dedicated to developing precision medicines for genetically defined neurological and immunological diseases, are looking for an Associate Director, Regulatory Affairs to join their team.


    Leveraging recent advancements in human genetics alongside drug development powered by advanced Data Science and biomarker platforms, my client is committed to advancing therapeutics for devastating diseases and looking for someone who can help support in getting them there.

    Reporting to the Head of Regulatory Affairs, you will be responsible for managing overall regulatory activities supporting clinical studies. This includes developing and implementing regulatory strategies, engaging in submissions, and corresponding with regulatory agencies.

    Overseeing multiple programs, collaborating with cross-functional groups and CROs to ensure compliance with good clinical practices, good manufacturing practices, and global regulatory guidelines.


    Key Responsibilities:

    to regulatory plans and strategies, proposing risk mitigation strategies, and influencing project teams towards desired lead in the development and implementation of strategies for timely regulatory interactions (e.g., FDA meetings and scientific advice) and submissions (IND, CTAs, CTIS).regulatory consultants and regulatory operations vendors effectively.abreast of regulatory requirements and communicate changes to relevant development of Standard Operating Procedures the clinical team to review and create essential clinical study the CMC lead to maintain Module 3 files and IMPD.regulatory timelines aligned with cross-functional project timelines.systematic updates to clients senior management on study statuses, facilitating timely problem-solving and risk QA consulting company to establish a Quality Management System (QMS).


    Qualifications:
    degree in a scientific discipline, with over 10 years of regulatory experience in pharmaceuticals, biotech, or CROs.

    Advanced degree and extensive experience in neurological disorders and/or immunology are advantageous.experience in pharmaceutical regulatory affairs, encompassing CMC, nonclinical, and clinical areas.experience in neurology and/or immunology is highly preferred, with a requisite understanding of small molecule development.

    Experience in companion diagnostics is regulatory environments in the EU, Canada, APAC, and the UK is preferred.proficiency in GCP, ICH guidelines, and FDA and EMA management skills, with the ability to prioritize deadlines and multitask effectively.ability to work collaboratively in multidisciplinary teams and independently under broad strategic guidance.communication skills, both verbal and written, capable of delivering compelling presentations to diverse audiences.


    This is a full-time position based in the San Francisco Bay Area, with a preference for hybrid office and remote work.

    Travel may be required for meetings with regulatory agencies. The estimated salary range is $175,000 - $200,000, commensurate with experience and qualifications. The client offers a comprehensive benefits package.


    Please let me know if this is something you would be interested in and happy to connect and discuss further.

    #J-18808-Ljbffr
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