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Job

Senior Director, Regulatory Affairs

  • Location

    San Francisco

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Avita Broukhim

  • Contact email:

    a.broukhim@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    5 months ago

  • Expiry date:

    2019-08-18

  • Startdate:

    ASAP

My client is a market lead in the biopharmaceutical space that addresses the significant unmet medical needs in rare diseases. My client is looking to hire a passionate Senior Director of Regulatory Affairs, who will report to the Vice President of RA, and will be responsible for the execution of all regulatory activities within his/her assigned area the organization along with the following:

-  Conducting strategic advice/decisions, coordination, and leading the team efforts to result in timely regulatory global submissions.

- Being the company expert on both FDA and EMEA regulations.

- Representing the company to regulatory authorities.

- Proactively identifying constraints or possible risks to programs in terms of regulations.

- Staying abreast of current regulations and competitive intelligence.

- Mentoring the department personnel and updating appropriate departments on the current regulatory environment, and others as assigned.

- Being hands-on for project team requirements.

- Serving as the regulatory project team lead for a designated project and as such would be responsible for the production of all major US and EU filings.

The Position's Requirements Include:

- 15 years or more of regulatory experience in a pharmaceutical company.

- Minimum of Bachelors’ degree.

- Previous experience with U.S. and European regulatory authorities required. Experience with Japan is also a plus.

- Deep familiarity with the overall drug development process especially related to clinical trial requirements for submissions required.

- Experience with BLA/NDA filing a must; experience with other filings highly desirable- IND filings, PSPs, PIPs, orphan and breakthrough product applications. 

- Preferred experience in Biologics.

- Previous mentorship experience of more junior regulatory staff.

- Familiarity with combination products of drug-device is a plus.

- Previous experience participating in FDA / EMEA or other regulatory meetings. 

- Strong writing, communication, and presentation skills. 

- Ability to travel internationally up to 20% of the time.

- Experience in Asia/pacific sector (i.e., Japan and Korea a plus).