Job Description:
Lilly is a global healthcare leader united by the mission to make life better for people around the world. Our employees work together to discover and bring life-changing medicines to those who need them, improve disease understanding and management, and give back to communities through philanthropy and volunteerism.
Purpose:
The Global Clinical Regulatory Associate, part of the Global Regulatory Affairs (GRA) Regulatory Delivery & Excellence (RD&E), is responsible for operational and technical registration management processes that support the delivery of safe and effective products to patients. This involves a strong working knowledge of regulations, guidance, and regulatory precedence.
Key Responsibilities:
1. Regulatory Expertise:
o Lead registration management processes by providing expertise in electronic submission regulations and guidance.
o Partner with other geographies to understand and incorporate local agency regulations and requirements.
o Guide development teams regarding internal and Agency registration management processes and requirements.
o Own registration management at the molecule/project level, ensuring timely, complete, and accurate electronic records.
o Serve as RD&E operational lead for registration planning and execution.
o Owning routine compliance submissions and processes.
o Partner with the Regulatory Coordinator/Scientist to drive product deletion and withdrawal processes.
o Provide registration management expertise to due diligence and business development processes.
o Serve as registration management expert for dependent processes.
2. Leadership and Collaboration:
o Develop collaborative relationships with personnel in other Lilly functional areas.
o Create an environment within team and GRA that encourages open discussions on issues.
o Develop collegial, mutually productive relationships with the FDA Office of Business Informatics (OBI).
o Partner with the Regulatory Scientist to plan, facilitate, and document internal, FDA, and partner meetings.
o Leverage internal and external forums to develop and share regulatory expertise.
o Influence others to create maximum advantage for the organization.
o Communicate verbally and in writing to influence within work groups/functions.
o Serve as a mentor within GRA.
Requirements:
* BS or higher degree in a technical discipline (chemistry, biology, pharmacy, or equivalent demonstrated industry experience).
* Knowledge of the drug development process.
Preferred Skills:
* Quick learning agility and retention of knowledge.
* Strong project management skills.
* Previous project management and global submission experience.
* Demonstrated ability to operate and manage operational requirements in highly regulated environments.
* Effective written, spoken, and presentation skills.
* Negotiation and influence skills.
* Attention to detail.
* Teamwork skills.