Lilly
healthcare
SrRegulatoryAffairsManagerDIA
“Sr Regulatory Affairs Manager- DIA at Lilly. Skills: regulatory expertise, China registration strategy, product registration approval. Provide regulatory expertise to propose China registration strategy through working closely with China and global study team and get alignment.. Implement, review and update regulatory strategy when necessary.”
What You'll Achieve.
ensure product registration approval; ensure market supply, artwork and labeling comply with agency requirement; Product Information should comply with local reg requirements, and the updated Product Information should be submitted, approved and implemented within the designated internal and/or MOH timelines.; produce accurate and high-quality Product Information which is in compliance with global core labeling.
Industry & Context.
analysis and/or solution of the issues
What They're Looking For.
Must Have
At least bachelor degree in pharmaceutical or chemicaliopharmaceutical sciences, At least 5-year experience in drug regulatory affairs, at least 3-year experience in global leading pharmaceutical company, Good skill on English writing, speaking and listening, Good skill on computer operation, Self-motivated and Innovative
Nice to Have
Leadership with people management/general management training
What You'll Do.
Provide regulatory expertise to propose China registration strategy through working closely with China and global study team and get alignment.
review and update regulatory strategy when necessary.
Ensure product registration related activities under Lilly’s policies and standard operating procedures
and other applicable laws and regulations.
Oversee the progress and ensure product registration approval.
Review product registration strategy and action plan.
Timely make recommendations to adjust the strategy to related functions and communicate with GRA (Global Regulatory Affairs) and China internal departments for the major changes and rationale.
Review and sign registration dossier and other regulatory documents to ensure the data presented fully represent what is practically required.
Timely communicate with regulatory authorities to get regulatory feedback.
Timely review and communicate registration progress and issues with related provide direction
and support as needed in analysis and/or solution of the issues.
Provide input and advice on the new product launch plan in terms of regulatory requirement.
Collaborate with related functions to ensure market supply
artwork and labeling comply with agency requirement.
Provide supervision on dedicated TA team
retain and grow junior RA colleagues (when applicable).
Participate in development and review of RA SOP and other RA functional system.
Ensure compliance with company policies
principles & procedures which China local team is trained on these aspects.
Perform the function of delegate ALRP role:
Product Information should comply with local reg requirements
and the updated Product Information should be 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.
Perform ad hoc projects or assignments.
How You'll Work.
Team & Collaboration
working closely with China and global study team; communicate with GRA (Global Regulatory Affairs) and China internal departments; Collaborate with related functions; Provide supervision on dedicated TA team, engage, retain and grow junior RA colleagues (when applicable); China local team is trained on these aspects
Communication Scope
English writing, speaking and listening
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