Regulatory Associate

Responsibilities
The purpose of the The Associate, GRA-NA, 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's and regulatory precedence and collegial and mutually productive relationships across Lilly components, partner companies, and within relevant ministries of health. The Associate utilizes process expertise and therapeutic area knowledge to drive appropriate internal consistency, and influence effective change management within GRA and cross-functionally. The scope of the work includes records from the start of clinical trials through withdrawal of the marketing application. It is expected that this position embrace corporate transformation initiatives and represent Global Regulatory Affairs-NA (GRA-NA) as a change ambassador

Provide Regulatory & Drug Development Expertise

• Lead the registration management process by providing expertise in electronic submission regulations and guidance and technical content for GRA-NA. This includes but us not limited to all submission associates with INDs, NDA, BLAs, NDSs, and other eCTD MAAs, and ensuring compliance with all applicable regulations and internal quality systems with a focus on delivery of the development portfolio across all modules of the CTD.
• Partner with other geographies to understand and incorporate local agency regulations and requirements as needed. For example, lead the planning and execution for electronic submissions in those regions who have and are adopting the eCTD specification
• 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 accurateRecords include:The IND and NDA submissionsTracking the status of pending applications and commitmentIncoming correspondence and records of contact
• Serve as the GRA-NA operational lead for registration planning and execution including but not limited to: critical chain planning sessions and status updates, team operation meetings and GRACRR planning.
• Own the routine compliance submissions and processes (e.g. DSUR, NDA/BLA annual reports, PSUR/PADER, routine maintenance submissions.
• Partner with the Regulatory Coordinator/Scientist to drive the execution of the product deletion, divestiture process, IND inactivation/withdrawal process, product withdrawal process
• 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 (e.g. OSI requests, out-license, user fees/drug listing/orange book)

Lead/Influence/Partner

• Develop collaborative relationships with personnel in other Lilly functional areas (e.g. medical, legal, labeling, compliance, quality, affiliates, etc.) to effectively influence the electronic registration plan.
• Create an environment within team and GRA that encourages open discussions on issues to achieve a robust outcome on project decisions and constructively challenge to reach the best solutions.
• Develop collegial, mutually productive relationships with the FDA Office of Business Informatics (OBI) to ensure understanding of the Agency's internal process and requirements to optimize the application presentation to facilitate review
• 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, drug development, and therapeutic 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 and with development team
• Serve as a mentor within GRA.

Company Overview
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 39,000 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

Basic Qualifications

• Bachelor's Degree. Scientific or health sciences discipline preferred (e.g. pharmacy, nursing, chemistry or related scientific discipline)
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Skills/Preferences

• Industry-related experience
• Masters or advanced degree
• Knowledge of drug development process, Lilly regulatory/business strategies and plans
• Demonstrated ability operate and manage operational requirements in a highly regulated environment
• Demonstrated effective written, spoken and presentation communication
• Demonstrated effective negotiation and influence skills
• Demonstrated attention to detail
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles

Additional Information
Lilly is an EEO/Affirmative Action Employer and 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