Lilly Regulatory Affairs Specialist- LCDDMAC in Bei Jing-北京, China
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 ( LillyRecruitingCompliance@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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!