Regulatory Affairs Specialist

2 weeks ago


Beijing, Beijing, China 1215 GlaxoSmithKline (China) Investment Co Ltd Full time

Role Overview:

We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team at GSK China. As a key member of our regulatory affairs team, you will be responsible for providing strategic and technical regulatory support to our line manager to ensure timely and high-quality submission and approval of our products in the Chinese market.

Key Responsibilities:

  1. Provide strategic and technical regulatory input and support to line manager to contribute to decision making on drug development strategy and license maintaining strategy to deliver the highest value to business.
  2. Provide high quality, clear and concise strategy input and advice on general regulatory topics.
  3. Independently compile high quality filing document complying with external and internal requirement to provide right and clear drug profile and data to NMPA to achieve targeted labeling and drug features to be approved.
  4. Independently engage with internal and external stakeholders to follow up every milestone closely to ensure issue identified, escalated, resolved timely and target filing and approval timeline plan is achieved.
  5. Establish and maintain a good relationship with key regulatory authority in daily work such as NMPA, CDE, NIFDC, CPC, etc. via professional communication.
  6. Make sure line manager fully informed products registration status in daily work.
  7. Support line manager on budget planning and monitoring in daily work.
  8. Provide timely and high-quality regulatory support and input to internal key stakeholders such as medical and commercial as needed.
  9. Significantly contribute or lead function continuous improvement initiative.
  10. Ensure timely and flawless implementation of company SOP and compliance requirement in daily work.

Requirements:

  1. A minimum of bachelor's degree in chemistry or biological or pharmacy.
  2. Minimum 8 years' experience in regulatory affairs field and at least 5 years in MNC.
  3. Proven ability to communicate (written/oral) with various functions and with authority.
  4. Fluency in English/Mandarin Chinese.
  5. Ability of cross functional co-operation.
  6. Strong ownership and cross boundary working mindset.
  7. A strong capability in problem solving.
  8. Strong ability of lobby, influence and negotiation.
  9. Ability to coordinate, influence and lead people or a virtual team.


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