Head of OTC Regulatory Affairs, China

Major Responsibilities：

• Provide leadership and strategic direction in Development and Regulatory Affairs for GSK China R&D and progress the provision of data for registration of new  products and line extensions in accordance with commercial objectives
• Provide  Regulatory input to due diligence / local acquisition activities.
• To provide leadership and direction in shaping a positive external regulatory environment to fulfil GSK China R&D’s commercial activities
• Direct, manage and co-ordinate day to day regulatory department activities including resource allocation, workflow, project priorities and department initiatives.
• Align regulatory plans and resource with local entity and global objectives.
• Develop effective working relationships and communications with key customer groups and internal and external stakeholders including Global regulatory, the SFDA and industry bodies
• Provide strategic regulatory input and direction to local, regional and international projects undertaken at the Shanghai  R&D facility and ensure appropriate ongoing regulatory support to subsequently register products for both local and export market needs.
• Ensure optimal performance from staff; implement appropriate training and development programmes for staff in the department in accordance with GSK policies and procedures to ensure currency of regulatory skills and behavioural competencies and longer-term succession planning requirements.

Requirement：

• BS in life sciences (Chemistry, biochemistry or pharmaceutical science)
• A minimum of 10 years experience within Regulatory Affairs, preferably including OTC Medicines, Cosmetics, Health Food and Beverage experience
• Proven experience in people leadership and project management
• Knowledge and experience of Chinese regulatory systems including relationships within SFDA
• A strong understanding of the new product development process
• Overall understanding of the Chinese FMCG and OTC  business environments
• Good communication and technical writing skills, excellent spoken and written English and Mandarin.
• Ph.D. or MS degree in life sciences
• Proven regulatory strategic thinking skills with a strong ability to interpret both global and the local market place legislation, and excellent personal relationships with SFDA
• knowledge of international regulatory systems, in particular the EU and USA systems
• Effective leadership and management skills and an ability to motivate staff and develop effective teams.
• Proven ability to work in and manage cross-functional teams across the business to achieve goals, through excellent customer focus.
• Strategic business overview with a strong understanding of the role of regulatory affairs in the global product development process and local commercialisation of products.
• Effective communication, influencing and negotiating skills
• Strong sense of integrity, ethics, commitment, diversity-awareness and highest professional standards.
• Ability to facilitate achievement of stretch objectives through result-oriented performance management systems.
• A broad range of experience including Oral Care products, TCMs and, Nutritional products would be a distinct advantage