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Regulatory Affairs Manager

7 months ago

Beijing, China Galderma Full time

Description

To prepare and submit regulatory application to obtain approval including for new products and the existing licenses renewal & variation. To monitor regulation change and analyze the change impact to the company. To be responsible for product testing in NMPA lab.

Key Responsibilities   

Work with function teams for all registration activities including documents preparation, type testing and e-submission per planned timeline.

Submit technical variations to local HAs within 2 months of receptions.

Ensure existing license renewed before expiry date.

Monitor the change of regulation, technical requirements and standards timely and adapt into product registration

Maintain or set up good working connection with the relevant authorities such as test labs, CMDE to improve working efficiency. 

Ensure labelling compliance before the approval , ensure the canton and IFU complies with relevant regulations

Follow company SOP for regulatory documentation archiving.

Provide RA support to cross functions per requests, attend routine meeting etc.

Skills & Qualifications   

BA degree in Medical, Biology, Pharmacy or Chemical or a combination of education and experience providing equivalent knowledge or above.

Minimum 6 or above years' experience in NMPA registration in class III projects. 

Experience in dealing with complex product issues and working across multiple functions to meet requirements.

Ability to communicate clearly both verbally and in writing

Excellent presentation skill

Fluent in English

What we offer in return  

At Galderma, you 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 that 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.