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Job

Associate Director Regulatory Affairs

  • Location

    Remote/Hybrid

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Samuel Cantillo

  • Contact email:

    s.cantillo@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    17 days ago

  • Expiry date:

    2022-07-08

The Associate Director will lead the company's regulatory strategy to support a growing vaccine, biologics, and cell & gene therapy portfolio. The Associate Director reports to the Director of Regulatory Affairs and will help oversee the development and implementation of worldwide regulatory strategy. The ideal candidate will independently carry out the following duties:
 

RESPONSIBILITIES

- Review and approve lisence application subsections
- Oversee worldwide label negotiations 
- Lead complex drug development programs 
- Effectively communicate risks with company's clinical and marketing internal stakeholders 
 

QUALIFICATIONS

- Minimum 4 years regulatory strategy and communications experience (small molecule or biologics)
- Working knowledge of FDA and EMA guidelines + working knowledge of international (LATAM, APAC) requirements for investigational and marketed products required.
- Bachelor's degree; advanced degree preferred 
- Experience managing regional consultants

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