VP of Regulatory Affairs - REMOTE

Boston Permanent USD220,000 - USD300,000
  • Exciting opportunity to build out Regulatory function at high-growth start up
  • Own Regulatory aspects of programs approaching the clinic in both US and China

About Our Client

Our client is an early stage high-growth start up focused on small molecule drug discovery in the metabolic disease space.

Job Description

  • Define Regulatory Affairs strategy according to target product profile, evaluate submission relevant documentation for regulatory compliance and suitability for registration, and oversee preparation of different types of regulatory submissions
  • Understand and interpret complex project related issues, provide expertise based on regulation requirements and regulatory best practices.
  • Master both US and China regulations for product registration
  • Anticipate potential challenges in registration and changes in health care policies that could impact business and develop strategies to optimize the outcome
  • Responsible for interactions and communications with authorities in China and worldwide (e.g. NMPA, FDA, etc.).

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

  • Bachelor's degree and above in pharmacy, pharmacology, chemistry or biological sciences.
  • 10+ Years experience in drug development and regulatory affairs, with extensive experience in managing major projects
  • Experience interacting with both local and international Regulatory Authorities.
  • Experience with NDA, ICH, NMPA or FDA requirements
  • In depth knowledge of drug development process, Regulatory obligations and guidelines
  • Experience developing and implementing regulatory strategy and managing negotiations with Regulatory Authorities

What's on Offer

  • Competitive base salary and benefit package
  • Career growth and progression
  • 100% Remote work flexibility
  • Exciting opportunity to completely own and build out Regulatory function at high-growth start up
  • Own Regulatory aspects of programs approaching the clinic in both US and China
Moriah Sweeney
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Job summary

Life Sciences
Sub Sector
Healthcare / Pharmaceutical
Contract Type
Consultant name
Moriah Sweeney
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