Regulatory Affairs Associate

Sanrafaelvet

Submit and follow up registration applications
Maintain currency of labelling and pack leaflets
Accurate translations of relevant documents
Prepare local documents, submit and follow up registration applications, under supervision of the Head of Affiliate Regulatory Affairs, to ensure that marketing authorizations are obtained or maintained in line with the business plan

Job Summary

  • Prepare local documents, submit and follow up registration applications, under supervision of the Head of Affiliate Regulatory Affairs, to ensure that marketing authorizations are obtained or maintained in line with the business plan.
  • Ensure to file new product registration and update the current registration file in timely manner.
  • Bring the miracles of science to life alongside a supportive, future-focused team.

Matching Summary

Prepare local documents, submit and follow up registration applications, under supervision of the Head of Affiliate Regulatory Affairs, to ensure that marketing authorizations are obtained or maintained in line with the business plan.

Skills & Requirements

Must-have

  • Submit and follow up registration applications
  • Maintain currency of labelling and pack leaflets
  • Accurate translations of relevant documents
  • Establish good relationship with Health Authority officers
  • Cross-functional support needs

Nice-to-have

  • Propose solutions to problems
  • Comply with HSE policy
  • Drive to set ambitious objectives
  • Cooperative attitude

Key Requirements

  • Scientific background (Pharmacy) essential
  • At least 2 years experience in regulatory affairs field in Taiwan
  • Work experience in Taiwan FDA (TFDA) preferred
  • Proficiency in written and spoken Chinese and English

Work Rights

Not specified

Tailored Resume

Cover Letter