- Senior Management
- P.R. China - Shanghai
Our client is a global Life Science Regulatory and Market Access advisory firm assisting biotech and medtech companies to develop innovative HealthTech products. The company supports its clients throughout product development from the design of CMC, non-clinical and clinical development plans and regulatory strategies to their implementation and submissions to regulatory agencies and players. Its expertise encompasses the full spectrum of HealthTech products: drugs, including biologics and cell, gene and tissue therapies, medical devices, including In-Vitro Diagnostics/CDx, combination products, and borderline products, as well as nutraceuticals and cosmeceuticals.
The company has been operating for 20+ years. The Company has few hundred employees, with professionals located across Europe, the USA and APAC. The Company offers rewarding and stimulating career opportunities to its employees due to the diversity of its clients and novelty of their products.
The Company is looking for the General Manager who will mastermind, create and manage its Chinese subsidiary by recruiting a team of talented Regulatory Scientists offering regulatory advisory services for product registration at the National Medical Products Administration (NMPA) for foreign and domestic clients.
Profile & Job description:
(Profile): About You!
- You are a physician, an engineer or pharmacist and you started your career in hospitals or in the pharmaceutical industry in China.
- You understand the importance of regulatory science in the development of HealthTech products. You have worked at NMPA or you are familiar with NMPA requirements to obtain marketing authorizations for drugs or medical devices.
- Being familiar with the Chinese healthcare system is a plus.
- You had a proven experience as an executive role in a CRO or a consulting firm for the biopharma/medtech industries.
- You master business processes and functions (finance, HR, procurement, operations etc.) and you are at ease in planning and budgeting.
- You have outstanding organizational and leadership skills.
- You demonstrate a strong analytical ability together with a synthetic view.
- You develop and maintain an extensive network in the regulatory environment including links/contacts to NMPA.
- You have excellent communication skills and a good problem-solving aptitude.
Global objectives of the role:
- To advise Company Management on its strategy to enter the Chinese regulatory advisory market.
- To seek opportunities for growth by developing business relationships.
- To set-up China operations by recruiting and supervising a high-performing team over the next 18 months to achieve sales, market share, and business plan objectives.
- To develop the group market share in NMPA regulatory services among the international community of its clients.
- To uphold standards of excellence and soaring quality.
- To provide guidance to clients and employees.
- To develop close ties with other Company operations, to implement combined international approaches to clients.
- To oversee day-to-day operations, assigning performance goals to your team and assuring their completion.
- To market proactively the Company’s capabilities with international clients as well as China-based clients.
- To advise clients on regulatory strategies regarding NMPA interactions and to ensure that their projects are well managed (timelines and quality of dossier authoring).
- To develop processes, to guide employees, to establish a highly motivated work environment among and between the Company Chinese operations.
- To enforce the Company group policies, procedures, standards, specifications, guidelines, and cultural values as they fit in the Chinese context.
- To advise the Company Management regarding Chinese specific policies and events which might have a direct influence on the development of the group in China.
- To resolve internal staff conflicts efficiently and to the mutual benefit of those involved.