Title: Regulatory Associate
Location: Indianapolis, IN
Start date: ASAP
- BS or higher degree in a technical discipline such as chemistry, biology, pharmacy or equivalent demonstrated industry experience.
- Experience with: eCTD Express, MS SharePoint, PM experience helpful
- Exp w/Global Regulatory Submission Experience
- Knowledge of drug development process, 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
This role 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 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 is capable of representing Global Regulatory Affairs.
- Provide Regulatory & Drug Development Expertise
- Lead the registration management process by providing expertise in electronic submission regulations and guidance and technical content for global submissions. This includes but us not limited to all submission types (Ad Promo, INDs, NDA, BLAs, NDSs, other eCTD MAAs, Renewals and Variations), 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 accurate. Records include: tracking the submission status of pending applications and commitments as well as all communications with regulators (Incoming correspondence and records of contact).
- Serve as the regulatory operational lead for registration planning and execution including but not limited to: planning sessions and status updates, team operation meetings and local department planning.
- Own the routine compliance submissions and processes for molecules within areas of assigned responsibility (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