Sr. Associate/Manager - Regulatory CMC

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.

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.

We believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.  ​

Purpose:

The CMC Regulatory Associate (RA), Regulatory Delivery Excellence (RDE), leads in partnership with the GRA-CMC Regulatory Scientists, various aspects of clinical trial and marketing authorization submissions. The RA also partners with GRA-CMC Scientists to create and manage RIM submission content, and to provide guidance on structure and content placement within CTD registration submissions, and to provide assistance with submission related Ministry of Health responses or Lilly affiliate questions. This is accomplished by a strong working knowledge of internal procedures, guidance’s and regulatory precedence.  The RA will triage and manage the communications between our Lilly Affiliates, GRA-CMC Scientists, and the Quality/ Reg Representatives. The RA utilizes GRA-CMC submission process expertise and their expertise with Information Technology tools to develop project management expectations across projects.

Regulatory & Drug Development Expertise

• Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, of CMC RA submission processes, electronic submission regulations and guidance regarding structure requirements to CMC development teams regarding global CTAs and registration dossiers.
• Partner with the CMC Regulatory Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development products.
• Partner with the CMC Regulatory Scientist to drive the execution of submission planning for global registration submissions.
• Responsible for triage of Lilly affiliate inquires and requests and when necessary, consults with CMC RA Scientist for guidance in effort to prepare responses to questions.
• Implement and in some cases interpret global regulations and guidance’s and look to regulatory precedence into submission processes and publishing standards to ensure final document content and structure are aligned with local regulatory requirements. Partner with Lilly affiliate regulatory staff, as necessary, to gain alignment on establishing new submission standards to meet local agency requirements.

Lead, Influence, Partner

• Create an environment within the Global Regulatory Area and across CMC development teams that encourages open discussions on issues to achieve a robust outcome on project decisions. Constructively challenge teams to reach the best solutions to issues.
• Leverage internal forums to continue to develop and share regulatory and drug development expertise to meet critical product registration timelines and electronic submission structure and content requirements.
• Communicate effectively to guide and influence within work group/function and with development team regarding life-cycle management processes
• Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues across multiple functions and geographies

Minimum Qualification Requirements:

• Bachelor’s Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related scientific dis