Lilly
SrRegulatoryAffairsManagerDIA
“Sr Regulatory Affairs Manager- DIA at Lilly. Skills: China registration strategy, regulatory strategy, product registration approval, regulatory authorities communication, new product launch plan, market supply compliance, artwork compliance, labeling compliance, Product Information compliance, global labelling procedures. Provide regulatory expertise to propose China registration strategy. Implement, review and update regulatory strategy”
What You'll Achieve.
ensure product registration approval; 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, Innovative
Nice to Have
Leadership with people management/general management training
What You'll Do.
Provide regulatory expertise to propose China registration strategy
review and update regulatory strategy
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
Review and sign registration dossier and other regulatory documents
Timely communicate with regulatory authorities to get regulatory feedback
Timely review and communicate registration progress and 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
Participate in development and review of RA SOP and other RA functional system
Ensure compliance with company policies
principles & procedures
Perform the function of delegate ALRP role
Product Information should comply with local reg requirements
updated Product Information should be submitted
approved and implemented within the designated internal and/or MOH timelines
Follow global labelling procedures
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 and get alignment; communicate with GRA (Global Regulatory Affairs) and China internal departments for the major changes and rationale; Cross-functional collaboration; Collaborate with related functions to ensure market supply, artwork and labeling comply with agency requirement; provide direction, guidance, and support as needed in analysis and/or solution of the issues
Communication Scope
English writing; English speaking; English listening; Timely communicate with regulatory authorities; Timely review and communicate registration progress and issues
Process & Methodology
Review product registration strategy and action plan, Timely make recommendations to adjust the strategy to related functions, Oversee the progress and ensure product registration approval
Applying for this Sr Regulatory Affairs Manager- DIA role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Lilly?
Real rants from real employees. Read before you apply.