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Associate Director-Regulatory Affairs, China
Purpose:
The purpose of Associate Regulatory Affairs Director role is to assist regulatory department head on business planning, develop regulatory strategy and manage all the regulatory project(s) of responsible therapeutic area (TA). Recruit, supervise, train and develop team members, and contribute to local GRP (Good Regulatory Practice) construction.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
1. Provide regulatory leadership, expertise & value in strategic planning through working closely with global RA and global study team, and get alignment among TA core team to accelerate the submission, approval & launch of responsible TA new pipeline (new molecules, indications & line extensions) to improve patient outcomes in China.
2. Implement regulatory strategies to accelerate submissions & approvals of new products & meet regulatory milestones through operational excellence.
3. Ensure product registration and other regulatory affairs activities under Lilly’s policies and standard operating procedures, and other applicable laws and regulations.
4. Interact with regulatory authorities and timely communicate with Lilly internal departments of product registration issues.
5. Monitor and evaluate the new regulations/guidance, regulatory changes/trends, and communicate with internal stakeholders under the direction of regulatory department head.
6. Participate in the construction of GRP in RA team.
7. Cross-functional collaboration
§ Provide input and advice on the new product launch plan in terms of regulatory requirement.
§ Collaborate with related functions to ensure market supply sufficiency, artwork and labeling comply with agency requirement and marketing promotion needs.
8. Ensure compliance with Company regulatory policies, principles & procedures that the local team is aware and trained on these aspects.
9. Provide supervision on dedicated TA team, engage, retain and grow team members.
10. Perform the function of delegate ALRP role.
§ As Delegate ALRP and through managing the Team Members, ensuring that Product Information complies with Local reg requirements and that updated Product Information is submitted, approved and implemented within the designated internal and/or MOH timelines.
§ Follow global labelling procedures and document relevant exceptions in order to produce accurate and high-quality Product Information which is in compliance with global core labeling。
11. Perform ad hoc projects or assignments.
Minimum Qualification Requirements:
§ At least bachelor’s degree in pharmaceutical or chemical/biopharmaceutical sciences
§ At least 8-year experience in drug regulatory affairs with at least 3-year supervisor experience in global leading pharmaceutical company
§ Good skill on English writing, speaking and listening
§ Self-motivated and Innovative
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