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Sr. Associate/Manager - Regulatory CMC, Cork
Client: Lilly
Location: Cork, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: 11434a71fecb
Job Views: 106
Posted: 21.01.2025
Expiry Date: 07.03.2025
Job Description:
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.
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.
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.
* Partner with the CMC Regulatory Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development products.
* Responsible for triage of Lilly affiliate inquiries and requests and when necessary, consults with CMC RA Scientist for guidance.
* Implement and interpret global regulations and guidance into submission processes to ensure final document content and structure are aligned with local regulatory requirements.
Lead, Influence, Partner
* Create an environment within the Global Regulatory Area and across CMC development teams that encourages open discussions on issues.
* Leverage internal forums to continue to develop and share regulatory and drug development expertise.
* Communicate effectively to guide and influence within work group/function and with development team regarding life-cycle management processes.
* Bachelor’s Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related scientific discipline) is required.
Other Information/Additional Preferences:
* Knowledge of Agency submission procedures and practices.
* Ability to operate and manage operational requirements in a regulated environment.
* Attention to detail and ability to effectively prioritize.
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.
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