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.
Organization Overview: The purpose of the Regulatory Affairs Specialist (Quality & Operation) role is to ensure quality and compliance of regulatory activities in China, and steer the operational achievements in Regulatory Affairs and provide a comprehensive consolidation; Ensure Regulatory team’s GRP compliance in operation.
Responsibilities:
- To support the regulatory documentation tracking, recording and archiving. Guide RA team and execute to manage the license/approval letter, labelling, annexes and withdrawal letter, etc.
- Ensure timely and flawless implementation of company SOP and compliance requirement in daily work.
- Coordinate on China local process development and SOP/WI update.
- To manage related RA systems and provide operational expertise to RA team to ensure the timely, quality execution on systems, and ensure the compliance to SOPs.
- Collaboration with the RA team to monitor the system readiness and improve the system performance continuously.
- To implement Quality Control/Quality Assurance in the Regulatory Affairs to ensure quality of the regulatory submissions and compliance.
- Work together with internal team and external vendors to introduce new system, and tools to China RA team timely. Support on technology development and innovation.
- Provide new employees training and conduct system related trainings to China RA team.
- Support on internal and/or external compliance monitory/audit.
- China RA share drive management. Manage China RA share drive and ensure periodically make CCI review
- Cross-Function coordinator (e.g. clinical trial registration, DSUR, etc)
- Sample archiving management and temperature monitor.
- Undertake any other duties as requested by superior/team with high quality before the deadline required by superior/team.
Basic Requirements:
- At least bachelor’s degree in Biz Admin, English or Medical/Pharmaceutical related major, at least 1-3 year’s related working experience.
- Good command of computer operation skill (i.e. Microsoft Word, Excel, PowerPoint, Outlook, etc.)
- Self-motivated and Innovative
- Ability to positively impact colleagues and teams
- Very good command of English writing, speaking and listening skill
- Good communication skill
Additional Skills/Preferences:
- Capability of working independently
- A fast learner of new things
- Being optimistic when dealing with emerged situation and always focus on how we improve
- Interpersonal/teamwork skills for effectiveness interactions
- Self-management skills with a focus on results for timely and accurate completion of completing deliverables
- Demonstrated problem solving ability and attention to details
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.
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