Associate/ Sr. Associate
4 weeks ago
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 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.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself
Purpose:
The Global Clinical Regulatory Associate, Global Regulatory Affairs (GRA) Regulatory Delivery & Excellence (RD&E), is accountable for the operational and technical registration management processes that support the expedited delivery of safe and effective products to patients.
This is accomplished through a strong working knowledge of regulations, guidance, and regulatory precedence.
Primary Responsibilities:
1.
Provide Regulatory & Drug Development Expertise
Lead the registration management process by providing expertise in electronic submission regulations and guidance.
Partner with other geographies to understand and incorporate local agency regulations and requirements.
Guide and influence development team and function regarding internal and Agency registration management processes and requirements.
Own the registration management process at the molecule/project level to ensure all required electronic records are timely, complete, and accurate.
Serve as the RD&E operational lead for registration planning and execution.
Own the routine compliance submissions and processes.
Partner with the Regulatory Coordinator/Scientist to drive the execution of the product deletion and withdrawal processes.
Provide registration management expertise to the due diligence and business development processes.
Serve as the registration management expert for other processes dependent upon the registration record.
2.
Lead/Influence/Partner
Develop collaborative relationships with personnel in other Lilly functional areas.
Create an environment within team and GRA that encourages open discussions on issues.
Develop collegial, mutually productive relationships with the FDA Office of Business Informatics (OBI).
Partner with the Regulatory Scientist to plan, facilitate and document internal, FDA, and partner meetings.
Leverage internal and external forums to continue to develop and share regulatory expertise.
Influence others in a manner that creates maximum advantage for the organization.
Communicate verbally and in writing to effectively influence within work group/function.
Serve as a mentor within GRA.
Minimum Qualification Requirements:
BS or higher degree in a technical discipline such as chemistry, biology, pharmacy or equivalent demonstrated industry experience.
Knowledge of drug development process.
Other Information/Additional Preferences:
Quick learning agility, retention of knowledge, strong project management skills.
Previous project management and global submission experience.
Demonstrated ability to operate and manage operational requirements in a highly regulated environment.
Demonstrated effective written, spoken and presentation skills.
Demonstrated effective negotiation and influence skills.
Demonstrated attention to detail.
Demonstrated effective teamwork skills.
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