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Senior Manager Regulatory Affairs

  • Job type: Permanent
  • Location: San Francisco
  • Salary: Competitive
  • Job reference: MSLN080717
  • Sector: EPM Scientific, Regulatory
  • Date posted: 07/08/2017
Our client, A clinical stage biopharmaceutical company is looking for a Senior Manager, Regulatory Affairs to come on board and make an immediate impact. The Senior Manager of Regulatory Affairs will provide leadership on global clinical regulatory activities. Responsibility will mainly focus on clinical regulatory filings and providing strategic as well as operational leadership on the project teams in this area.

Responsibilities:
- Lead IND/CTA and NDA submissions activities, as well as international submission activities
- Develop regulatory strategic plans in conjunction with project teams and assist in the preparation of clinical submissions required for regulatory approval
- Effectively plan, organize, and conduct in close collaboration with leads from other functional areas. Assure compliance with project team timelines and milestones

Qualifications:
- Bachelor’s degree in a Life Sciences discipline or equivalent, advanced degree preferred
- Must have 5 to 8 years of biopharmaceutical experience, and at least 5 years of hands-on regulatory affairs and successful IND and NDA/MAA submission experience
- Experience with international and particularly EU regulatory submissions and an understanding of worldwide small molecule guidelines and regulations a plus.
If you are interested, please apply below!
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