Department/location: Shanghai/Suzhou China
Must relocate or currently reside in China. Suzhou or Shanghai base
Position Reports To: VP&GM NorthEast Asia and dotted line to VP Analytical Regulatory and Scientific Affairs
Primary Duties and Responsibilities
- Work closely with clients in China to identify formulation, analytical, clinical and regulatory needs of dosage forms related to drug delivery technologies.
- Leverage global resources to provide support to identified needs and speed up development and regulatory process at clients.
- Deploy and develop China capabilities to better address local service needs and support global service approach.
- Collaborate with global BD and support local commercial team to realize targeted service revenue in China.
- Build in-depth understanding of industry regulations, communicate effectively to multiple departments at local and global level and ensure that information is interpreted correctly
- Monitor emerging trends regarding industry regulations, assess potential impacts and recommend proper strategies to avoid negative impact.
- Develop relationships with China regulatory agencies and major laboratories. Represent at scientific and regulatory roundtables, seminars and other events.
- Prepare and/or guide clients in the preparation of high-quality dossiers for generic and new drug registration with device in China and other markets.
- Lead and develop the team to achieve all goals. This is People manager role that will lead a team of 3-4 and will grow to at least 6 in two years