Regulatory Affairs Specialist

PharmEng Technology is looking for RA professionals to join our Asia RA team. He/she will work with our client, a Multinational Pharmaceutical Company, to assist their local regulatory team in China, Beijing. This is a full-time position.


Job Description:
  • Provides input into the development of submission strategies for new product  and works with others to negotiate with China towards rapid approval with optimum labeling
  • Conduct submission to CFDA for Generic products as well as post-approval variations (local processing and submission of global variations received from head office)
  • Provides input into the planning and supports preparation of regulatory submission to aggressive targets, within a team environment
  • Ensures regulatory compliance with China FDA requirements and alignment with business needs
  • Liaises with multiple local and global functional groups to ensure China regulatory needs are met
  • Identifies and responds to issues related to assigned projects
  • Interprets China regulations, guidelines and policies as they apply to company’s commercial activities
Job Requirements:
  • A bachelor's degree or college diploma in pharmaceutical or a related discipline.
  • At least three (3) year experience working in regulatory affairs
  • Must possess a thorough understanding of the regulations of China FDA
  • Highly innovative ,creative problem solver and decision maker
  • Fully developed project management skills
  • Ability to continuous improvement techniques to gain efficiencies in submission preparation and product approval process
  • Strong interpersonal skills, with strong written and oral communication skills
  • Must act with integrity and demonstrate a strong and effective risk management perspective
  • Computer literate with excellent knowledge of Office Applications
Industry:
Biotechnology and Pharmaceuticals
Employment Type:
Full-time Employee
Experience:
Mid-Senior Level
Job function:
Regulatory Affairs
Location:
Beijing, China (1 Position)
Shanghai, China ( 2 Positions)
 
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