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Associate Director, Regulatory Affairs Project Manager

  • Job type: Permanent
  • Location: Massachusetts
  • Salary: $160000 per annum
  • Job reference: MSLN629201711013
  • Sector: EPM Scientific, Regulatory
  • Date posted: 29/06/2017
Location: Cambridge, MA
Salary: $160,000 +stock + benefits

A leading Pharmaceutical firm is looking to hire an Associate Director, Project Management-Regulatory Affairs to be based in their Cambridge, MA office. This company is experiencing rapid growth due to a number of recently approved products by the FDA. It is an exciting time to join this innovative company and they are planning on continuing their global expansion in the next few years.

Responsibilities:
- Manage operational oversight to ensure high-quality regulatory submissions
- Plan and conduct submission meetings
- Work with program teams to formulate submission plans
- Identify opportunities for efficiencies and process improvements

Qualifications:
- Bachelor's Degree
- Minimum of 5 years of regulatory experience in pharmaceutical industry
- Experience in preparing regulatory submissions (NDAs/BLAs, INDs, CTAs, DSURs, annual reports)
- Strong understanding of FDA regulations

If you are interested in this opportunity, please apply!

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