At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Regulatory Delivery Excellence (RDE), China Regulatory Affairs is responsible for activities related to the regulatory registration management processes and submission preparation support. The scope of the work includes the clinical trial permit (CTP) applications through withdrawal of the marketing applications.
**Primary Responsibilities: **
Manage the registration process by providing expertise in submission regulations, guidance and technical contents. Ensure compliance with all applicable regulations and internal quality systems.
Develop submission plans for assigned projects:
Partner with Regulatory TA & CMC team members, vendors and other contributing functions to develop submission plans, including dossier lists, timelines etc.
Collaborate with the related functions to ensure effective execution of the submission plan.
Manage RIM-related activities and collaborate with GRA RD&E team to support the submission plan
Escalate issues that may impact submissions and timelines.
Support regulatory TA & CMC teams on submission related activities:
Arrange translations and manage the quality checks of translated materials.
contribute local Module 1 documents to RIM content plans for new MAAs, Line extensions and new indications
Author administrative documents based on guidance from Regulatory scientists
Perform document formatting and manage the quality checks
Compile submission dossiers according to the submission plan
Execute QC testing-related activities, including material ordering, contract execution, and vendor communication etc.
Serve as the Subject Matter Expert (SME) for regulatory business processes and how those are executed in the Veeva Vault RIM system to ensure consistency of process execution and data.
Input and maintain data in China/global IT system, e.g. RIM, China submission archive and maintenance platform, etc.Develop collaborative relationships with personnel in the related functions (e.g. CRP, SC, GPS, Stats, CDTL, CSM, GRA RD&E,etc.) to effectively execute the registration plan.
Leverage internal and external forums to continue to develop and share regulatory, drug development, and therapeutic expertise.
Minimum Qualification Requirements:
- At least bachelor’s degree in pharmaceutical or chemical/biopharmaceutical sciences
- At least 2 year experience in drug regulatory affairs or drug development for manager (P2)
- Preferable to experience in leading pharmaceutical company
- Demonstrated project or submission management capabilities are preferred
- Good skill on English writing, speaking and listening
- Exceptional interpersonal, teamwork, and communication skills are required.
- Self-motivated
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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