About this role
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.
Detail works of P4 RA who is SME of gene therapy products
1. Gene therapy products registration
- Make registration strategy
- Deliver China authority requirements
- Prepare and submit registration dossier
- Lead project team to provide query response
- Order product samples and support national lab to complete QC testing
- Get product approval
2. Development RA team gene therapy capability
- Interpretate China authority and global regulation and guidance on gene therapy products
- Introduce gene therapy knowledge to team members
- Help team to build up document template of gene therapy product to standardized the requirements
3. Environment shaping
- Do intelligence working, including monitor China and global regulations and guidance update, monitor competitor registration status
- Interpret the intelligence news, analyze impact to Lilly’s business, and provide constructive comments/strategy
- As Lilly’s representative, shape regulatory environment by leveraging different platforms.
4. Minimum qualification requirements:
- At least bachelor degree in pharmaceutical or chemical/biopharmaceutical sciences, master most preferred
- At least >5 year of experience in Gene therapy regulatory affairs
- Fluent in written and spoken English.
- Self-motivated and Innovative
- Leadership with people management/general management training
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.
#WeAreLillyOther facts
About Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world. It all started nearly 150 years ago with a clear vision from founder Colonel Eli Lilly: "Take what you find here and make it better and better." Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing science to solve some of the world's most significant health challenges.
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If you have questions about a Lilly medicine, contact The Lilly Answers Center at 1-800-Lilly-Rx (1-800-545-5979) Monday through Friday, excluding company holidays.
What you'll do
- The role involves developing registration strategies for gene therapy products and leading project teams to ensure compliance with regulatory requirements. Additionally, the position includes shaping the regulatory environment and enhancing the team's capabilities in gene therapy.
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