Regulatory Affairs Manager- LCDDMAC
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 39,000 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.
The purpose of this role is to closely monitor China regulatory environment and ensure timely provision of intelligence to Lilly China RA and relevant functions. Ensure Regulatory team’s GRP compliance in operation.
Regulatory Intelligence and Shaping Regulatory Environment
- Closely monitor and analysis China regulatory environment, ensure timely disseminate intelligence information to RA team members and other relevant functions.
- Lead for discussion of draft regulation in commenting process and assist in gathering comments from relevant functions. Compose Lilly’s comments to regulatory authorities and external trade associations.
- Fulfil regulatory intelligence requests in support of therapeutic area projects.
- Provide regulation support for cross-functional discussion and knowledge sharing.
- Join Industry Association regulatory related committees, on behalf of Eli Lilly, advocate for regulatory hot topics trying to influence regulatory environment.
- Organize team training on new regulatory environment changes, help deliver more learning resources both in Lilly internal and external.
- Support MOU work stream(s) to leverage Lilly expertise to contribute China regulatory evolving.
- Maintain and develop CN RA website and information databases and promote the use of the website and database.
- At least bachelor’s degree in pharmaceutical or chemical/biopharmaceutical sciences, 2-3 year’s regulatory experience is preferred.
- Very good command of English writing, speaking and listening skill
- Self-motivated and Innovative
- Ability to positively impact colleagues and teams.
- Good cross-functional communication skill
- Good command of computer operation skill Additional Preferences
- Capability of working independently
- A fast learner of new things
- Being optimistic when dealing with emerged situation and always focus on how we improve
- Interpersonal/teamwork skills for effectiveness interactions
- Self-management skills with a focus on results for timely and accurate completion of completing deliverables
- Demonstrated problem solving ability and attention to details
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-4784.
Lilly is an EEO/Affirmative Action Employer and 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.
Our scientists and researchers are developing the breakthrough medicines of tomorrow. Join us and become a creative innovator and thinker who can improve the lives of millions.
We’d love to meet you to discuss career opportunities. Check our calendar now to see when we’ll be in your area.View All Events
By signing up for job alerts, you’ll be the first to learn about opportunities that could be a great fit for you via periodic email updates.Sign Up
Join Our Talent Community
Share a bit about yourself, such as the career area you are interested in. We will then reach out to you when the perfect position is available!Sign Up