Manager - Global Regulatory Affairs (GRA) Regulatory Delivery & Excellence (RD&E)

Eli Lilly and Company•Indianapolis, IN

1d•$63,000 - $149,600

About The Position

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 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. Purpose: The Global Regulatory Associate, Global Regulatory Affairs (GRA) Regulatory Delivery and 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 around the world. This is accomplished through a strong working knowledge of regulations, guidances 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 embraces corporate transformation initiatives and represent GRA as a change ambassador.

Requirements

BS in a technical or scientific discipline (such as chemistry, biology, pharmacy)
2+ years of experience with drug development process

Nice To Haves

Quick learning agility, retention of knowledge, strong project management skills, flexibility, organizational skills, and fast adoption of new technology solutions are very important for success in this role.
Previous project management and global submission experience
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 skills
Demonstrated effective negotiation and influence skills
Demonstrated attention to detail
Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles

Responsibilities

Provide Regulatory, Submission Planning and Execution Expertise Lead the registration management process by providing expertise in electronic submission regulations and guidance and technical content on a global and regional level. 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 delivery of the development portfolio across all modules of the CTD. This role may act to produce and submit eCTD submissions globally or regionally.
Ensure incoming correspondence are archived accurately and related to appropriate records, assuring all metadata fields are complete in RIM. Partner with other geographies and Regional Submission Associates for non-eCTD countries to provide submission content in support of non-eCTD submissions in line with local agency regulations and requirements as needed. For example, utilize approved submission requirements provided in Regulatory systems to create submissions through the use of RIM technology allowing this role to lead the planning and execution for non-eCTD submissions and also drive any new electronic submissions in those regions who have and are adopting the eCTD specification.
Support Affiliate Regulatory/Alliance Managers with RIM content planning for IND, MAA, Line extensions and new indication submission types. Create global and where appropriate regional content plans matching appropriate documents to support submission strategies defined by global regulatory strategy scientist or Regional/Affiliate Regulatory staff. 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 IND and MAA submissions, tracking the status of pending applications and commitments, incoming correspondence, and records of contact Serve as the RD&E operational lead for registration planning and execution including but not limited to critical chain planning sessions and status updates, team operation meetings and RD&E planning.
Own the routine compliance submissions and processes (e.g. DSUR, NDA/BLA annual reports, PSUR/PADER, routine maintenance submissions). Partner with the Global Regulatory Strategy Scientist/Regional/Affiliate Regulatory Staff to drive the execution of 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) Partner with Regulatory Policy to identify areas of desired change in the external environment Take advantage of evolving technology and regulatory requirements to identify and seek opportunities for novel submission processes (eg. Cloud-based submissions)
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.
As directed by leadership, develop collegial, mutually productive relationships with the FDA Office of Business Informatics (OBI) and applicable regulators in other countries to ensure understanding of the Agency's internal process and requirements to optimize the application presentation to facilitate review Partner with the Affiliate/Regional Regulatory Staff to plan, facilitate and document internal, regulator, 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 and SME for RD&E processes.

Benefits

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

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