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  • CMC Regulatory Affairs manager - Mumbai - Lifelancer

    Lifelancer
    Lifelancer Mumbai

    1 month ago

    Default job background
    Full time
    Description

    Job Title: CMC Regulatory Affairs Manager

    Location: Remote, India

    Contract Type: Full-time

    Seniority Level:


    Lifelancer is a talent-hiring platform in Life Sciences and IT.

    We connect professionals with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.

    The ideal candidate will have expertise in regulatory affairs, particularly in the area of Chemistry, Manufacturing, and Controls (CMC).

    This includes experience with regulations such as FDA, EU GMP, and ICH guidelines.

    The manager will oversee the development and implementation of regulatory strategies to ensure compliance and expedite product approvals.

    Key responsibilities include leading cross-functional teams, managing regulatory documentation, and maintaining relationships with government agencies and industry partners.

    This role requires strong leadership skills, excellent communication abilities, and a deep understanding of regulatory requirements.

    The successful candidate will be responsible for developing and executing regulatory plans that meet business objectives and minimize risk.

    They will work closely with internal stakeholders to ensure alignment and provide expert guidance on regulatory matters.

    A bachelor's degree in a relevant field, such as life sciences or law, is required. A master's degree or Ph.D. is preferred.

    The ideal candidate will have at least 8 years of experience in regulatory affairs, including experience in a leadership role.

    This position offers a competitive salary and benefits package, as well as opportunities for growth and professional development.


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