Regulatory Affairs Manager
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.
Be responsible for Diabetes products registration and relevant device
- Under the general direction of supervisor, independently perform product registration and other activities.
- Participate in the development of regulatory affairs strategy and action plan.
- Compile registration dossier and ensure timely regulatory submission upon internal review and approval.
- Communicate with regulatory agencies/institutes (e.g., NMPA, PFDA, CDE, NIFDC, CPC, Provincial Drug Control Institutes) on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing.
- Timely /closely monitor regulations and review process for ensuring the data presented fully represent what is practically required and the constantly changing regulations to be followed. Ensure earliest possible registration.
- Properly maintain all regulatory documentation.
- Cross Functional
- Provide regulatory expertise to the new product launch activity if necessary.
- Provide inputs and assistance in the development of study protocol in terms of regulatory requirements.
- Provide expertise from regulatory point of view to ensure market supply and drug inspection complying with local regulations.
- Participate in development and review regulatory affairs SOP and other functional system.
- Ensure compliance with Company regulatory policies, principles & procedures and the local team is aware and trained on these aspects.
- Perform ad hoc projects or assignments.
- At least Bachelor’s degree in pharmaceutical or biopharmaceutical sciences (Master is preference).
- At least 4-years’ experience in drug regulatory affairs in pharmaceutical company (MNC experience will be preferred).
- Good understanding of relevant regulations, guideline etc.
- Good leadership and project management skills.
- Good command of English writing, speaking/listening skill and computer operation skill.
- Good team player and communication skill.
- Self-motivated and self-learning initiative.
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-2945.
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.
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