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Biotechnology company based in Singapore is seeking for a Regulatory Affairs Director

  • Job type: Permanent
  • Location: Singapore
  • Salary: $100000 - $120000 per annum
  • Job reference: 207482
  • Sector: EPM Scientific, Regulatory
  • Date posted: 17/07/2017
• Responsible for the management and conduct of the US regional regulatory activities for assigned projects in line with the US regulatory requirements and function as the liaison between the FDA and the company as well as external stakeholders

• Serve as CMC regulatory subject matter expert to product development and technical teams on manufacturing changes, line extensions, technical labelling, to ensure regulatory compliance

• Preparing, compiling, reviewing, and processing the regulatory submissions including both pre-approval and post approval submissions such as IND, NDA/BLA, amendments/supplements, annual reports, study protocols, study reports, investigator brochures, safety reports, etc.

• Perform gap analysis on CMC regulatory dossiers to ensure completeness for submissions

• Conducting regulatory communications with the FDA for assigned products and activities

• Act as liaison between FDA, the company and other external stakeholders as required

Experience and skills: 8 – 10 years of experience in regulatory FDA, experience in lifecycle management

If interested in this role, please send in an updated CV/ resume along with salary, notice period and location to apply.a33ho1ggpyt@epmscientific.aptrack.co.uk or call me at +65 94790492.

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