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Associate - Clinical Regulatory

Employer
Eli Lilly and Company
Location
Indianapolis, Indiana
Start date
Feb 2, 2024

View more

Discipline
Clinical, Clinical Research, Regulatory
Required Education
Associate Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work

Job Details

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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Clinical Regulatory Associate, Regulatory Delivery Excellence (RDE), 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 Global Regulatory Affairs (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.

Responsibilities:

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Provide Regulatory & Drug Development Expertise

  • Lead the registration management process by providing expertise in electronic submission regulations and guidance and technical content. 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 accurate. Records include IND and NDA submissions, tracking the status of pending applications and commitments, incoming correspondence, and records of contact.

  • Serve as the RDE operational lead for registration planning and execution including but not limited to critical chain planning sessions and status updates, team operation meetings and RDE 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

Basic Requirements:

  • BS or higher degree in a technical discipline such as chemistry, biology, pharmacy or non-technical discipline with 15 years regulatory experience.

  • Minimum 2 years previous regulatory submission experience including in RIM and eCTD Publishing experience.

Additional Preferences:

  • To be successful in this role quick learning agility, retention of knowledge, strong project management skills, flexibility and organizational skills are very important. 

  • 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

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
Location
893 S Delaware St
Indianapolis
Indiana
46285
United States

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