Head of China Regulatory Affairs - Dermatology and Device
Shanghai
Permanent
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Brining global premium skincare, dermatology, dental products to China
Biotechnology market driven company
About Our Client
Our client is a newly established sister company of international skincare focused business with over 30 years history. Their global product and research pipeline has been developing around dermatology area. Key indications include hyper-pigmentation, acne, ageing skin, sun protection, dehydration, peeling solutions for consumer and professional use.
Job Description
- Hands on support registration of Rx Drig and Medial Device Class II and Class III categorised products prioritised for the pipeline - manage regulatory filings for CFDA submissions
- Develop and implement regulatory strategies that enable the delivery of a pipeline of product innovation to meet the aligned business strategy for China market
- Ensure regulatory compliance to maintain routine product registration for the company pipeline
- Work closely with Head or Research and Development on Regulatory Strategy for current pipeline and pipeline planning
- Take active role in Global Safety activities to ensure Safety compliance with local regulations
- Supporting development of solid internal regulatory expertise for cross functional team within China business
The Successful Applicant
- Degree in Medical field or similar major desired
- Strong background in Regulatory Affairs for Dermatology and Skin Care Category
- Entrepreneurial mindset and readiness to work in a fast-paced environment
- Track record with China Registration of Rx Drugs, Medical Devices Class II and Class III
- Proficient knowledge of the pharmaceutical and medical device R&D, product development, regulatory and quality environments
- Fluent English is a must, native Chinese speaker
What's on Offer
You will be offered competitive compensation package along with stock option as the company preparing IPO in 2022.