Regulatory Affairs Specialist

2 weeks ago

Beijing, Beijing, China Galderma Full time

Job Summary

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Galderma. As a key member of our regulatory team, you will be responsible for preparing and submitting regulatory applications to obtain approval for new products and existing license renewals and variations.

Key Responsibilities

  • Work closely with cross-functional teams to ensure timely registration activities, including document preparation, type testing, and e-submission.
  • Submit technical variations to local health authorities within 2 months of receipt.
  • Ensure existing licenses are renewed before expiry dates.
  • Monitor regulatory changes, technical requirements, and standards, and adapt product registration accordingly.
  • Maintain good working relationships with relevant authorities, such as test labs and CMDE, to improve working efficiency.
  • Ensure labeling compliance before approval and ensure canton and IFU compliance with relevant regulations.
  • Follow company SOP for regulatory documentation archiving.
  • Provide RA support to cross-functional teams as needed.

Requirements

  • Bachelor's degree in Medical, Biology, Pharmacy, or Chemical, or a combination of education and experience providing equivalent knowledge or above.
  • Minimum 6 years' experience in NMPA registration for Class III projects.
  • Experience in dealing with complex product issues and working across multiple functions to meet requirements.
  • Excellent communication and presentation skills.
  • Fluent in English.

About Galderma

At Galderma, you will have the opportunity to gain new and challenging work experience and create an unparalleled, direct impact. We offer careers in innovation and accountability, empowered by diverse, collaborative colleagues across functions and geographies who share their passion to advance dermatology for every skin story.

Our People Make a Difference

At Galderma, you'll work with people who are like you. And people who are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

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