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    Director, Global Regulatory Strategy - Neurology

    EPM Scientific
    Parsippany, NJ 07054
    Full-time, Part-time
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    Job Description

    Job Description

    Director, Global Regulatory Strategy - Neurology

     

    Company Summary: Join a growing pharmaceutical company with over 10,000 employees worldwide focused on developing their neurology and oncology portfolio. This position will focus on all aspects of global regulatory strategy from early development through post approval. Interacting directly with global Health Authorities as well as successful preparation and submission of INDs/CTAs/MAAs/NDAs/BLAs will be crucial as the Director of this quickly evolving team. 

     

    The Director of Global Regulatory Strategy will be responsible for:

    ·        Acting as the Global Regulatory lead (GLR) for all responsibilities assigned to the portfolio

    ·        Constantly creating and updating all aspects of regulatory strategy as they apply to domestic and global guidelines

    ·        Having a strong knowledge of FDA guidelines, changes, and updates on a global level

    ·        Conducting meetings with Health Authorities/submitting proper documentation of the highest quality

    ·        Cross functionally working with multiple branches to ensure smooth and efficient processes

     

    Requirements of the Director, Global Regulatory Strategy:

    ·        BS in a scientific discipline (Masters preferred)

    ·        10+ years of industry regulatory strategy experience

    ·        Preparation of IND/CTA/sNDA/Type II variation submissions is needed

    ·        Exposure to successful NDA, MAA and/or BLA filings preferred

    ·        Demonstrated ability to think strategically in drug development settings

    ·        Ability to travel 10% based on business needs

    Company Description

    EPM Scientific is a global specialist recruitment company working exclusively in the Life Sciences industry. As an industry expert we understand that the ongoing changes within the Life Sciences industry make the ability to attract and maintain industry-leading talent a key priority.

    As of today EPM Scientific has consultants based all over the world, from our own fully licensed and compliant offices in New York, Boston, San Francisco, Los Angeles, Charlotte, Chicago, Dallas, London, Zurich, Berlin, Singapore, and Hong Kong, and unlike many other companies, we have grown organically.

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    Posting ID: 598942204Posted: 2021-01-26