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Job

VP, Regulatory Affairs

  • Location

    Greater New York City Area

  • Sector:

    Regulatory

  • Job type:

    Permanent

  • Contact:

    Storm Hagan

  • Contact email:

    s.hagan@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    RA1274

  • Published:

    3 months ago

  • Expiry date:

    2018-08-16

  • Startdate:

    ASAP

Vice President, Regulatory Affairs – Greater New York City Area

My client, who is an industry leader in the development rare disease therapies, is currently looking for a very experienced regulatory affairs professional, to head up their regulatory function for North America. This is a very unique opportunity that does not come around often, and will give you the chance to build up a regulatory affairs team around you. If you or someone you know has any interest, don’t hesitate to get in touch.

Key Requirements:

  • Knowledge of US regulations desired, EU experience is a plus.

  • Working knowledge of Biologics or small molecule products.

  • Strong knowledge of regulatory operations, working with BLA and eCTD submissions.

  • Ability to liaise with the FDA as well as orchestrate meeting with the FDA and other regulatory agencies.

  • Strong management skills are required.

Qualifications:

  • Bachelor’s degree from accredited university required. Advanced degree are highly desired.

  • US Work Authorization.

  • Clean driving record.

 

Please also note that due to the high volume of applications for this role, if you have not been contacted by a Hamlyn Williams representative in 5 working days you can assume that at this point your application has been unsuccessful, we will however retain your information and contact you about other opportunities that may better suit you experience.