Regulatory Affairs Director, Bio-Med
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 35,000 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 Regulatory Affairs Director Bio-med is to assist RA Dept Head in regulatory and business planning, develop regulatory strategy for responsible TA products, manager regulatory project. And recruit, supervise, train and develop team members, and contribute to local GRP construction.
- The Regulatory Affairs Director Bio-med will be responsible for developing regulatory strategy for Bio-med TA product and managing regulatory projects.
- Provide regulatory leadership, expertise & value in strategic planning through working closely with international RA and BU RA teams, and get alignment from TA core team task force to accelerate the submission, approval & launch of responsible TA new pipeline (new molecules, indications & line extensions) to improve patient outcomes in China.
- Implement regulatory strategies to accelerate submissions & approvals of new products & meet regulatory milestones through operational excellence.
- Ensure product registration and perform regulatory affair activities under Lilly’s policies and standard operating procedures, and other applicable laws and regulations.
- Communicate with regulatory agencies/institutes and Lilly internal departments on product registration issues.
- Monitor and evaluate the new regulations/guidance, regulatory changes/trends, and communicate with internal stakeholders under the direction of RA Dept Head.
- Participate in the construction of GRP in RA team.
- Develop people and stabilize the team through strong leadership to make sure continuous support to filling project.
Provide input and advice on the new product launch plan in terms of regulatory requirement.
Collaborate with related functions to ensure market supply sufficient, artwork and labeling comply with agency requirement and marketing promotion needs.
- Ensure compliance with Company regulatory policies, principles & procedures and the local team is aware and trained on these aspects;
- Supervision on dedicated TA RA team engage, retain and grow junior RA colleagues.
- Perform ad hoc projects or assignments.
- 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
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-18882.
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