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. Our goal is to improve the human condition by bringing life-changing medicines to those who need them most.
We believe in the talent of our workforce and strive to utilize and develop that talent by promoting from within. 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. To be considered, you must meet the minimum qualifications outlined in the job description and have work authorization in the country where the position is located.
Purpose:
The CMC Regulatory Associate (RA), Regulatory Delivery Excellence (RDE), leads various aspects of clinical trial and marketing authorization submissions. The RA partners with GRA-CMC Scientists to create and manage RIM submission content, provide guidance on structure and content placement within CTD registration submissions, and assist with submission-related Ministry of Health responses or Lilly affiliate questions.
Key Responsibilities:
* Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including ICH CTD and evolving global agency standards, CMC RA submission processes, electronic submission regulations, and guidance regarding structure requirements to CMC development teams.
* Partner with the CMC Regulatory Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development products.
* Drive the execution of submission planning for global registration submissions.
* Triage Lilly affiliate inquiries and requests, and consult with CMC RA Scientist for guidance when necessary.
* Implement and interpret global regulations and guidance, and leverage regulatory precedence into submission processes and publishing standards to ensure final document content and structure align with local regulatory requirements.
Leadership Skills:
* Create an environment that encourages open discussions on issues to achieve robust project decisions.
* Leverage internal forums 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 groups/function and with development teams regarding life-cycle management processes.
* Demonstrate strong problem-solving skills and ability to address and 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 discipline).
* Knowledge of pharmaceutical drug development or industry-related experience preferred.
Additional Preferences:
* Drug development process or Industry-related experience.
* Knowledge of Agency submission procedures and practices, as well as emerging electronic submission standards.
* Ability to operate and manage operational requirements in a regulated environment.
* Strong written, spoken, and presentation skills.
* Negotiation and influence skills.
* Attention to detail and ability to effectively prioritize.
* Proven effective teamwork skills, with ability to adapt to diverse interpersonal styles.
Lilly 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.