A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
This position is based in Shanghai or Beijing.
This position will manage regulatory affairs for Life Science (LS) business in Great China with effective management and strategy development. Drive, manage and coordinate regulatory projects, including managing thought leadership initiatives, product registrations, supporting business regulatory needs, customer training/requests. Facilitate and maintain excellent working relationship with government officials and customers.
- Effective manage regulatory pathway for Life Science (LS) products and services in Great China, cover the areas of biopharma processing, pharm & food testing, pharm & food materials (APIs, pharmaceutical excipients, food additives), medical devices, IVDs, etc.
- Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry associations in terms of Life Science interests. Safeguard company strategic interests and objectives in arising guidance, standards and regulation.
- Monitor and report on changes of relevant regulatory and compliance environment with impact with the Life Science business. Analyze available regulatory and compliance information.
- Effective coordination of strategic activities with the company subject matter experts, local regulatory bodies and industry associations. Secure flow of information from/to authorities, industry associations and the Life Science organization.
- Training and support to internal stakeholders, external customers and relevant regulatory bodies. Provide relevant training to educate local marketing/sales colleagues about new regulatory trends and developments that drive our value proposition. Definition of processes to implement upcoming regulatory needs and requirements.
- Closely work with global/regional regulatory surveillance & advocacy team and regulatory subject matter experts to link the local advocacy activities with global/regional advocacy activities.
- Drive, manage and coordinate registration / notification / listing activities. Ensure the correctness and timeliness of these activities, interim follow-up change management and final outcome. Ensure tracking, maintenance and reporting of registration / notification / listing status.
- Provide regulatory guidance in risk assessment, identify regulatory impact to Life Science and provide regulatory recommendations to mitigate potential risk. Take active role to represent company in delicate or risk potential matters with regulatory agencies, inspectors and trade associations.
- Provide regulatory support to marketing, sales and customers via consultation, seminars and training events.
Who you are:
Education and Languages:
- Master in life sciences or related science / engineering background with a strong emphasis in pharmaceuticals & biotech.
- Fluent in Chinese native & English (verbal and written) is required.
Professional Skills and Experience:
- Experience of minimum 12 years in pharmaceutical & biotech Industry, extensive knowledge in pharmaceutical and life science products.
- Broad and extensive regulatory knowledge of China laws and regulations of NMPA and CFSA. Familiar with US and European regulations and industrial regulatory guidelines in above mentioned areas.
- Experience working in a global, matrix environment. Ability to work in multi-cultural teams.
- People management experience to lead a team in complex and fast changing environment.
- Excellent interpersonal, presentation, listening and communication skills that will develop long term internal and external relationships at all levels.
Personal Skills and Competencies:
- Strong organizational and time management skills. Effective management by influence.
- Ability to manage multiple priorities and deliver accurate outcomes.
- Ability to indirectly influence other organizations and cultures.
- Ability to train and educate others.
- Experience in thought leadership.
- Proficient in MS Office Software (Word, Excel, PowerPoint, Project).
- Be able to travel.
Functional Area: Regulatory & Medical Affairs
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com