Remote 505(b)(2) NDA Regulatory Strategist - San Francisco, CA - Pharmatech Associates

    Pharmatech Associates
    Pharmatech Associates San Francisco, CA

    1 day ago

    Description

    Job Title: Remote 505(b)(2) NDA Regulatory Strategist

    At Pharmatech Associates, we are seeking a highly experienced Regulatory Consultant to lead our strategy and manage 505(b)(2) NDA submissions. This role requires at least 10 years of experience in regulatory affairs, specifically with FDA regulations and regulatory strategy development.

    The ideal candidate will have a strong background in global regulatory applications and excellent communication skills. They should be able to effectively communicate complex information to cross-functional teams and external partners.

    • Develop and execute comprehensive regulatory strategies for multiple clients across the pharmaceutical industry.
    • Collaborate closely with cross-functional teams, including clinical operations, quality assurance, and medical writing.

    We offer:


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