Accessibility Links

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.

Similar jobs
Director Marketing
  • Job type: Permanent
  • Location: New Jersey
  • Salary: $150000 - $200000 per annum
  • Description Renown Pharmaceutical generics company is looking for a high-level Marketing candidate to oversee pricing of injectable products. The Position will be responsible for overseeing the...
Associate, Rates Product Control
  • Job type: Permanent
  • Location: New York
  • Salary: $100000 - $140000 per annum
  • Description Associate, Rates Product Control This is a top investment bank that has been growing their middle office teams rapidly over the last few months. The...
Senior Regulatory Affairs Manager (Medical Devices)
  • Job type: Permanent
  • Location: Brussels
  • Salary: €90000 - €100000 per annum, Benefits: 15%
  • Description My client enables healthier lives, everywhere, every day, by bringing to market innovative diagnostic, medical imaging, surgical and medical aesthetic products.  They are interested in...
Senior Product Manager
  • Job type: Permanent
  • Location: South San Francisco
  • Salary: $100000 - $150000 per annum
  • Description This multi-billion dollar pharmaceutical company in the San Francisco area is looking for qualified candidates to be an integral part of driving the successful launch...
Senior Director/Vice President - Oncology
  • Job type: Permanent
  • Location: Germany
  • Salary: Competitive
  • Description A growing biotech is loooking for a medical leader to support their growth across Europe. They are passionate and committed to changing the lives of...