Senior Scientist, Regulatory CMC – China
Reporting to the CMC Principal Scientist, International CMC (China), the successful candidate will be responsible for assessment of changes for regulatory impact, development of China CMC strategy, preparation of CMC documentation and execution of regional post-approval CMC supplements and new product registrations for the entire product portfolio of small molecule, biologic and biosimilars, serving as a link between Country Regulatory Affairs (CRA) team requirements and global CMC strategy to ensure right first-time submissions to Health Authorities. He/she will work closely with CMC Product Leads to ensure that key CMC projects are successfully prosecuted in China.
The incumbent will be accountable for implementing CMC strategy for China for post-approval CMC supplements and new product submissions with a focus on achieving right-first-time submissions, including the following activities:
- For assigned product portfolio, develop robust local (China) CMC regulatory strategies for new marketing applications, Scientific Advice and post-approval changes, as appropriate.
- Working collaboratively with Global CMC Regulatory Affairs Product Leads, the team will ensure right first-time submissions, high approval rates, on target launches and successful implementation to maintain patient supplies throughout the lifecycle.
- Ensure that the China CMC regulatory strategy is aligned with the global regulatory strategy, Franchise portfolio, commercial and operational strategies and issues impacting product approval, launch or patient supplies will be appropriately escalated to CMC Regulatory Affairs Management.
- Support local Country RA affiliate interactions with their local Regulatory Agencies to facilitate Scientific Advice and the prompt review and approval of submissions (as CMC content subject matter expert).
- Act as Regulatory CMC SME in China post approval requirements, ensure awareness of local regulatory policy trends and maintain/update the regulatory intelligence repository for China, including communicating proactively with Global CMC Product Leads on local registration requirements, new legislation and guidance and providing timely update of the CMC change management systems to support right first time submissions.
- Ensure high quality and timely responses to Regulatory Agency questions and fulfillment of regulatory commitments to Regulatory Agency deadlines.
- Support product compliance by ensuring local registrations and lifecycle management align with product manufacturing details.
- Drive continuous process improvement activities within the organization and participate in forums to ensure efficient processes and best practice.
- Influence CMC initiatives by internal and external engagement including trade associations and regulators to pursue priority advocacy plans impacting the business.
- The candidate must possess a Bachelor’s or Master’s Degree in chemistry, pharmacy, biology or a related science, with a minimum of 4 years of experience in the pharmaceutical industry, in Regulatory Affairs and/or Technical Regulatory.
- The ideal candidate will have experience in Regulatory Affairs for China, with a focus on Regulatory CMC requirements for small molecule/biologic/biosimilar products, development, manufacturing and/or quality assurance. Direct Health Authority experience would be an advantage.
- He/she will demonstrate effective problem solving, understanding of regulatory strategies, excellent interpersonal skills, detail oriented, and able to prioritize multiple tasks.
- Must have a proven ability to communicate effectively in both a written and verbal format, in both Chinese and English.
- Ability to influence and work both independently and collaboratively in a team structure.
- Proven ability to work well under pressure.
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