Regulatory Affairs Specialist- 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.
Under the supervision of TA Team Leader, perform and manage day-to-day product registration, and ensure timely completion.
- Ensure operations in compliance with local applicable laws, regulations, and guidelines; Lilly’s policies and SOPs.
- Compile registration dossier and prepare other regulatory documents, ensure that the data presented fully represent what is practically required and ensure timely regulatory submission upon internal review and approval.
- Communicate internal and external on product registration issues, including but not limited to regulatory inquiries, review committee meetings, sample testing.
- Closely follow up product review process.
- Properly maintain all regulatory documentation.
Effective communications with all functional contacts
- Provide regulatory expertise to the new product launch activity if necessary
- Provide expertise from regulatory point of view to ensure market supply import and drug inspection complying with local regulation.
Participate in regulatory affairs SOP and other internal system review and revision; Ensure compliance with Company regulatory policies, principles & procedures and the local team is aware and trained on these aspects; Assist in RA tasks/activities assigned Perform the function of delegate ALRP,
- 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
Minimum Qualification Requirements:
- At least Bachelor’s degree in pharmaceutical or chemical/biopharmaceutical sciences
- Preferable to experience in drug regulatory affairs in leading pharmaceutical company
- Good skill on English writing, speaking and listening
- Good skill on Computer operation
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-7086.
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