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Director of Regulatory Affairs-Remote

  • Job type: Permanent
  • Location: Rockville, Maryland
  • Salary: US$180000 - US$220000 per year
  • Job reference: 274901/002_1559857186
  • Sector: EPM Scientific, Regulatory
  • Date posted: 06/06/2019

Title: Senior Project Lead, Regulatory Affairs

Salary: $180,000-$220,000

This globally focused clinical-stage biopharmaceutical company is looking for a crucial member to join their team in a brand-new role. This company just received $150 million in Series C Financing and they currently have six development programs in their pipeline and are looking for a lead to have all hands-on deck. If you are a person looking for a challenging but rewarding position this role is for you. Did I mention that this can be done remotely?

Key Responsibilities

  • Lead in filing for assigned IND, CTA and NDA submissions to health authorities(FDA,EU etc.)

  • Function as a regulatory affairs lead representative in project development team.

  • Establish and implement global regulatory strategy and plan for assigned projects.

Qualifications

  • BA/BS required; advanced degree highly preferred.

  • Global regulatory experience highly desirable.

  • Oncology drug development experience is a must

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