Regulatory Affairs Supervisor
Regulatory Affairs Supervisor
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Job Description
Job Title: Regulatory Affairs Supervisor
Location: Shanghai/ Beijing China
Job Description
- Manage registration dossiers. Ensure accurate and timely preparation of regulatory submissions of new products variation and maintenance of existing registration to obtain timely approval of product registration from NMPA/Local FDA.
- Provide regulatory guidance consultation interpretation and advice to relevant departments to ensure compliance with regulatory guidelines/directives/national requirements.
Key Responsibilities
Work with global team and local team to prepare for registration /notification submission and follow up of files required for cosmetic license for new renewal and change projects address question raised by NMPA/ SH FDA to get approval in a timely manner.
Ensure regulatory compliance in terms of product formula raw materials and claims
Monitor cosmetic promotional operations (training material product leaflet brochure etc.) for compliance
Maintain good communication with regulatory agencies/institutes (e.g. CDC SGS PONY) on product registration and testing ensure expected testing result and testing proceeded per timeline .
Establish and consolidate the relationship with internal and external key stakeholders
Monitor regulatory environment in China with regards to standards literature regulations guidance documents etc. Analyses the impact to the company and shares with the relevant functions
Provide regulatory guidance consultation interpretation and advice to relevant departments to ensure compliance with regulatory guidelines/directives/national requirements
Achieve submitted documentations and ensure traceability
Skills & Qualifications
BA degree in Chemistry compound or pharmacy or a combination of education and experience providing equivalent knowledge or above
Minimum 3 or above years experience in Regulatory Affairs for Cosmetics
Extensive knowledge of cosmetic regulations and technical requirements in China
Must have ability to develop clear concise and timely oral and written reports plus communicate tactfully with global/local project team personnel.
Demonstrated ability in project management skills in order to plan conduct and implement regulatory submissions
Skill in determining alternatives that would correct a situation to comply with standards and regulations
Good level of communication both in Chinese and 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 youll 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.
Required Experience:
Manager
Employment Type
Full-Time
