Head of Regulatory Affairs, Greater China

Major Responsibilities：

• Full responsibility of obtaining Marketing Authorizations for commercial products and Clinical Trial Authorizations as rapidly as possible in Greater China.
• To maintain these authorizations (variations and renewals) as necessary.
• Create RA strategy and plan for required documents, clinical trials, samples including budget and schedule.
• Full responsibility for the conformance of the regulatory studies in compliance to the SFDA requirement.
• Monitors and influences license progress to expedite and optimise the outcome.   Following approval, ensures the continuing validity of the license throughout the product life-cycle.
• Create and maintain relationship with relevant authorities in Greater China
• Provides regulatory advice to Corporate and relevant country on all aspects of development and licence maintenance work.
• Provide support to Commercial Operations with regulatory advice.
• Recruit and lead the Greater China Regulatory team effectively to ensure that there is a fully competent/knowledgeable team, making sure there is support for other areas of the business in new products, and that resources are deployed appropriately.
• Liaise between Global RA and the local offices (i.e. distributors, consultants, agents).
• Manage Country interface with Country, Regional, and Global, Development (Clinical, QA and PV teams), taking accountability for and optimizing all in-Country regulatory processes, while ensuring quality compliance, timeline and driving the ultimate success.
• Input Country medical and clinical interests into Global and Regional strategy and planning, through active collaboration with key officers and participation in key forums.
• With agreement from the GPT, support dissemination of trial-generated medical information to educate key influencers, including scientific and regulatory leaders within ethical and legal boundaries.

Requirement：

• Advanced bioscience degree. MD/PhD strongly preferred
• Extensive experience in the pharmaceutical industry (7-10 years)
• International regulatory experience, time and quality conscious, assertive personality.
• Cutting-edge scientific and clinical understanding
• Experience in a Regional and/or HQ roles
• Excellent understanding of relevant (Country-specific) ethical and legal guidelines, and the ability to ensure compliance with these external guidelines as well as internal standard operating procedures
• Strong leadership skills, including demonstrated ability to effectively lead and coach scientific/ medical professionals, as well as business-oriented colleagues, at all skill and knowledge levels
• Excellent interpersonal, communication, negotiation, and presentation skills
• Significant experience of risk management
• Scientific/medical research experience with demonstrated record of scientific/medical publication desirable
• Fluency in Chinese and English are required..