Regulatory Science Lead Neurology APAC - China
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- Develops and implements the regional regulatory strategy and plan consistent with the business objectives, inputting regional expertise into the global regulatory strategy and global planning in line with the GRL.
- Serve as the primary regional point of contact for the GRL, affiliates, and other Practices/Functions
- If applicable, responsible for facilitating and coordinating the regulatory regional product team in collaboration with GRL to ensure that objective priorities are met.
- Primary contact point with the (region) health authorities building strong relationships
- Responsible for ensuring that the regional regulatory strategy for the specific product(s), have been negotiated (if appropriate) with the regional health authorities and that the regulatory risks have been identified and mitigated
- Responsible for ensuring that the regional regulatory strategies, risks and mitigations and overall plans are effectively discussed with, endorsed by and communicated to the GRL, GRA TA Head, GRA LT, and other functions and affiliates as needed
- Coordinate the regional submission team
- Deliver regulatory submissions in line with the applicable regulations, directives and guidelines, and in line with agreed strategies and timelines.
- Ensure that all documents and information are adequately captured in a timely fashion in the applicable systems (document management, databases, etc).
- Prepare and communicate regulatory strategic and operational plans for assigned projects
- Assist in development of regulatory standards, efficient processes and SOPs
- Maintain awareness of our company and competitors’ activities in the region and share potential impact these activities may have on the product development program
- Maintain awareness of external regulatory environment, new guidelines and legislation.
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