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Job

Associate Director, Regulatory Affairs

  • Location

    Hessen

  • Sector:

    Life Sciences

  • Contact:

    Rob Steel

  • Contact email:

    r.steel@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    Associate Director, Regulatory Affairs

  • Published:

    22 days ago

  • Expiry date:

    2021-12-05

  • Startdate:

    ASAP

Hamlyn Williams has partnered with an innovative biopharmaceutical company that is in a big phase of growth. 

Due to growth, the company is looking for an Associate Director, Regulatory Affairs to provide support for European regulatory strategy. The European headquarters is in Hessen but the position can be primarily home-based if preferable.

 

The role involves but is not limited to:

• European regulatory strategy support for assigned projects, covering product development plans, clinical trials and Marketing Authorizations Applications (MAA) as well as product life cycle management.

• European Regulatory Affairs representation on global development teams providing regulatory guidance and strategy and supporting EU MAA submissions

• Act as regulatory contact person for authorities for assigned projects

• Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives.

 

If you are an experienced Regulatory Affairs professional and looking for a new challenge, please get in touch!