Lilly
Healthcare
Sr.RegulatoryAffairsManager
Neural analysis suggests this role is
optimal for Manager candidates.
“Sr. Regulatory Affairs Manager at Lilly. Skills: Regulatory affairs, China registration strategy, Product registration approval. Provide regulatory expertise. Propose China registration strategy”
What You'll Achieve.
Ensure product registration approval; Produce accurate product information; Produce high-quality product information
Industry & Context.
What They're Looking For.
Must Have
Bachelor's degree in pharmaceutical or chemical/pharmaceutical sciences, 5+ years drug regulatory affairs experience, 3+ years global leading pharmaceutical company experience, Good English writing, speaking, and listening skills, Good computer operation skills
Nice to Have
Leadership with people management/general management training
What You'll Do.
Provide regulatory expertise
Propose China registration strategy
Implement regulatory strategy
Review regulatory strategy
Update regulatory strategy
Ensure product registration activities compliance
Oversee product registration progress
Ensure product registration approval
Review product registration strategy
Make recommendations to adjust strategy
Communicate major changes
Review registration dossier
Review regulatory documents
Communicate with regulatory authorities
Get regulatory feedback
Communicate registration progress
Communicate registration issues
Provide input on new product launch plan
Advise on regulatory requirement
Collaborate to ensure market supply
Collaborate to ensure artwork compliance
Collaborate to ensure labeling compliance
Provide supervision on dedicated TA team
Engage junior RA colleagues
Retain junior RA colleagues
Grow junior RA colleagues
Participate in RA SOP development
Participate in RA SOP review
Participate in RA functional system development
Participate in RA functional system review
Ensure compliance with company policies
Ensure compliance with company principles
Ensure compliance with company procedures
Perform delegate ALRP role
Ensure product information compliance
Submit updated product information
Approve updated product information
Implement updated product information
Follow global labeling procedures
Document relevant exceptions
Produce accurate product information
Produce high-quality product information
Perform ad hoc projects
Perform ad hoc assignments
How You'll Work.
Team & Collaboration
China and global study team; China internal departments; Related functions; Cross-functional collaboration
Communication Scope
English writing; English speaking; English listening
Full Job Description
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 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. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. 1\. 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. 2\. Ensure product registration related activities under Lilly’s policies and standard operating procedures, and other applicable laws and regulations. 3\. 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 functions; provide direction, guidance,
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