(Sr.) Regulatory Affairs Manager, CMC
Beijing, Beijing Municipality
ResponsibilitiesUnder the general direction of supervisor, independently perform product registration and other activities.
1.Participate in the development of regulatory affairs strategy and action plan.
2.Compile registration dossier and ensure timely regulatory submission upon internal review and approval
3.Communicate with regulatory agencies/institutes(e.g., CFDA, PFDA, CDE, NIFDC, CPC, Coast Drug Control Institutes) on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing.
4.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.
5.Properly maintain all regulatory documentation.
1.Provide regulatory expertise to the new product launch activity if necessary
2.Provide inputs and assistance in the development of study protocol in terms of regulatory requirement
3.Provide expertise from regulatory point of view to ensure market supply import and drug inspection complying with local regulation.
•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
1. ALRP delegates with the labeling responsibilities are responsible for below duties:
2.Affiliate product information is consistent in content and emphasis with CDS, CD, local regulations and other reference labels as required locally.
3.Submit Proposed Truth copy for new Affiliate Product Information or label updates to regulatory authorities as required. Submit and implement label within the required time frame.
4.Ensure the accuracy of labeling translations, providing a complete and accurate Truth Package to Printed Packaging Development (PPD) and thorough review of Proof Copy.
5.Obtain internal reviewer and Global Product Team approval (with GoLD) if affiliate product/device information that are not consistent with Core Labeling, using SAIL to initiate the Labeling Change/ Exception Request.
6.Ensure labeling document retention, including the Master Truth Copy.
7.Use Lilly’s databases correctly.
8.After get approval letter, inform China Labeling Coordinator to start labeling artwork update/create procedure. 53934BR
Basic QualificationsAt least bachelor degree in pharmaceutical or chemical/biopharmaceutical sciences.
•At least 4-year experience in drug regulatory affairs in globe leading pharmaceutical company.
•Good leadership and project management skills.
•Good command of English writing, speaking/ listening skill and computer operation skill.
•Good team player.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID 53934.
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