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Purpose:
As a senior individual contributor, work independently to drive the new product registrations and life-cycle maintenance from a CMC perspective, including leading the CMC strategy development, dossier preparation, overseeing QC testing and managing query response. The Sr. Manager of RA CMC role reports to the RACMC chemical or biological group lead, and is also to play SME role in specific areas and shape regulatory environment by participating in TFs and leading discussions.
**Primary Responsibilities: **
1 Independently manage project registrations and daily regulatory work
1.1 Work independently on new product registration and life-cycle maintenance across IND, NDA/BLA to post-approval changes, and ensuring delivery of expected regulatory and business outcomes.
1.1.1 Lead and provide strategic, tactical, and operational direction to expedite CMC registration of Lilly’s new portfolio and to develop successful strategy to support product life-cycle maintenance.
1.1.2 Identify potential CMC risks, evaluate and develop mitigation plans
1.1.3 Prepare and proofread CMC documents for submission, and draft and review China specific CMC technical documents, such as IPS, MTP/MPF
1.1.4 Anticipate and resolve key technical issues that could impact CDE review and QC testing.
1.1.5 Familiar with China regulations and guidelines, can interpreted HA questions and their intensions to guide and address CMC questions from HA. For complicated projects or questions, can communicate with HA directly.
1.2 Network throughout and interacts directly with global RA CMC, global CMC PM, global supply chain and other CMC technical functions to provide China specific regulatory requirements, insights and regulations, give high-quality and timely advice to influence global team and achieve aligned CMC registration strategy, track document status to meet best possible timelines.
1.3 Collaborate with local cross-functional teams and stakeholders to provide CMC strategy, insights and project updates, work together to establish best possible regulatory strategy and support business growth.
1.4 Prepare HA communication meeting materials and can lead the meeting with HA regarding CMC topics
2 Actively gather intelligence, participate and shape regulatory environment, especially as an SME
2.1 Build and maintain a good relationship with key stakeholders, and grasp up-to-date regulatory trends and incorporate them into regulatory strategy & plan
2.2 Actively participate in and lead regulatory environment shaping activities through industry platforms (e.g. RDPAC, DIA, CMAC, ISPE)
2.3 Interpret and technically assess relevant regulations and guidelines
3 Contribute to team responsibilities including RA SOPs, task forces and other ad hoc initatives
3.1 Initiate and review of RA SOPs, and other RA functional processes
3.2 Contribute to optimize or improve internal document templates, guidance and processes, train or share to the team
3.3 Handle ad-hoc projects or assignments
4 Provide deep technical expertise in CMC area
4.1 Demonstrated technical knowledge and understanding of CMC drug development science, analytical techniques, DS and DP manufacturing and quality compliance system.
4.2 Can serve as SME in specific area, provide technical consultation and advice.
5 Ensure compliance with company policies, principles & procedures which China local team is trained on these aspects.
**Minimum Qualification Requirements: **
- At least Master degree in pharmaceutical or chemical/biopharmaceutical sciences
- At least >7 years experience in drug development or regulatory affairs with at least 3-year experience in global leading pharmaceutical company
- With hands-on experience of full NDA/BLA project from submission to approval
- Familiar with China regulation and ICH guidance. Knowledge of regulations and guidelines of FDA and EMA regulation and guidelines is a plus. For biological group candidates, deep knowledge of biological products development and registration, an experience of ADC, gene or cell therapy is preferred. For chemical group candidates, experience with novel therapeutic modalities is a plus, such as experience with synthetic peptides, SiRNA and Radio Ligand products.
- Good skill on English speaking, listening and writing
- Demonstrated communication and influence skills, problem-solving skills and the ability to work within a global and cross-function team
- Self-motivated and Innovative
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