Regulatory Compliance Specialist

1 month ago


Beijing, Beijing, China Galderma Full time

Galderma offers an exciting opportunity for a highly skilled Regulatory Affairs Manager to join our team.

The successful candidate will be responsible for preparing and submitting regulatory applications to obtain approval, including new products and existing license renewals and variations. This role requires strong analytical skills to monitor regulation changes and assess their impact on the company.

Key responsibilities include:

  • Collaborating with cross-functional teams to prepare and submit registration documents, conduct type testing, and manage e-submissions according to planned timelines.
  • Preparing and submitting technical variations to local Health Authorities (HAs) within two months of receipt.
  • Ensuring timely renewal of existing licenses before expiry dates.
  • Maintaining awareness of changing regulations, technical requirements, and standards, and adapting product registration processes accordingly.
  • Fostering strong relationships with relevant authorities, such as test labs and CMDE, to enhance working efficiency.
  • Ensuring labeling compliance prior to approval and verifying that Canton and IFU comply with relevant regulations.
  • Following company SOPs for regulatory documentation archiving.
  • Providing regulatory support to cross-functional teams as needed and attending routine meetings.

In this role, you will have the opportunity to gain new and challenging work experience while creating a direct impact. We offer careers in innovation and accountability, empowered by diverse, collaborative colleagues across functions and geographies who share their passion for advancing dermatology for every skin story.

We value professionalism, collaboration, and a friendly, supportive ethos, providing the perfect environment for individuals to thrive and excel in their roles.

This is a fantastic opportunity to grow your career and make a difference in the field of Regulatory Affairs.

Estimated salary: $120,000 - $150,000 per year.



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