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Director Regulatory Affairs

  • Job type: Permanent
  • Location: San Francisco
  • Salary: $160000 - $200000 per annum
  • Job reference: MLSN12218241
  • Sector: EPM Scientific, Regulatory
  • Date posted: 22/01/2018
Our client, An exciting and growing start-up biotech that is focused on the development and commercialization of novel cancer immunotherapies is looking for a Director Regulatory Affairs to join their growing team!
  • The Director, Regulatory Affairs will represent Regulatory Affairs on cross-functional teams and work closely with other team members to support corporate objectives.
  • An important aspect of this role is the capacity to contribute to the development and execution of optimal registration strategies for investigational products and/or additional indications for marketed products.
Specific Responsibilities:
  • Represent Regulatory Affairs on cross-functional teams, providing regulatory affairs strategy and support for assigned programs.
  • Maintain proactive/current awareness of regulations and guidelines pertaining to all aspects of programs.
  • Coordinate and lead communication with the relevant personnel at the FDA to ensure successful interactions with the agency.
  • Manage the compilation and submission of new Investigational Drug Applications (INDs) and Clinical Trial Applications (CTAs).
  • Responsible for IND maintenance for assigned products, which may include routine submissions as well as more substantial IND amendments, as needed.
  • Oversee submission build, compilation and publishing activities associated with generating hard copy and electronic submissions
  • Maintain US and ex-US submission files and logs.
  • As assigned, train, coach and mentor new or less experienced Regulatory Affairs staff.
Education and Qualifications:
  • BA/BS degree in related field required; advanced degree preferred (or relevant experience).
  • 8 to 12 years’ experience in regulatory affairs or related functions in drug/biologic development.
  • Experience with oncology drug development is highly desirable.
  • Experience with pre-IND meetings, IND applications, and IND maintenance (such as Annual Reports, Briefing Packages, Safety Reports and IND Amendments).

If you are interested, please apply below!
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