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Job

Sr. Manager/Associate Director, Regulatory Affairs

  • Location

    San Francisco

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Nikita Madan

  • Contact email:

    n.madan@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    4 months ago

  • Expiry date:

    2020-04-12

An international biopharmaceutical company with an exciting oncology and rare disease pipeline is looking for a Senior Manager/Associate Director to join their regulatory team in the Bay Area! They are looking for a professional to help focus on pivoting their products into Phase III of clinical trials while also working on several early stage drugs (making for a very stacked pipeline).

 

If you're interested in learning more about this company please do get in touch! This company is actively hiring.

 

RESPONSIBILITIES:

In this role you will be responsible for:

  • Provide regulatory strategic input for drug development projects, including but not limited, to health authority interactions, regulatory submissions and other regulatory requirements
  • Ensuring accuracy of all submissions in an appropriate and timely manner
  • Building strong relationships and collaborating with FDA
  • Provide CMC expertise for global development and registration programs (e.g., INDs, CTAs, NDAs and MAAs)

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REQUIREMENTS:

The client requires that all candidates have:

  • Bachelor's degree or higher in relevant field
  • 5-8 years of relevant experience
  • Experience in oncology or rare disease preferred
  • Track record of successful drug submissions/approvals
  • Understanding of global regulations
  • Strong communication skills
  • Ability to work on multiple projects simultaneously