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.
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At Lilly, we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate, and deliver while maintaining integrity, excellence, and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!
Position: Associate/Sr Associate Manager GRA (Regulatory)
Location: Bengaluru, Karnataka, India
The purpose of 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 strong working knowledge of regulations, guidance 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 the withdrawal of the marketing application.
It is expected that this position embraces corporate transformation initiatives and represents 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 is 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 the 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: The IND and NDA submissions tracking the status of pending applications and commitment incoming 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, the 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).
- 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 the 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 a maximum advantage for the organization.
- Communicate verbally and in writing to effectively influence within workgroup/function and with the development team
- Serve as a mentor within GRA
Minimum Qualification Requirements:
A BS or higher degree in a technical discipline such as chemistry, biology, pharmacy or equivalent demonstrated industry experience.
Other Information/Additional Preferences:
- M.Pharm. and higher education
- Experience with global regulatory affairs for the US, EU, and Canada
- Experience with global regulatory affairs for other OUS countries
- Experience with handling advertising and promotional materials for the US
- Industry-related experience
- Knowledge of drug development process, Lilly regulatory/business strategies, and plans
- Demonstrated ability to 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
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