Regulatory CMC Specialist

2 weeks ago

Cork, Cork, Ireland beBeeRegulatory Full time €80,000 - €104,000
Job Description

The Regulatory CMC Associate, part of the Regulatory Delivery Excellence team, plays a key role in managing global marketing authorization submissions. This includes partnering with GRA-CMC Scientists to create and manage submission content, as well as providing guidance on structure and content placement within CTD registration submissions.

Key Responsibilities
  • Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including ICH CTD and evolving global agency standards.
  • Prepare CMC CTD content consistent with approved manufacturing changes, technical reports, and procedural requirements.
  • Partner with the CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products.
  • Triage Lilly affiliate inquiries and requests, and consult with CMC RA Scientist for guidance when necessary.
Requirements
  • Bachelor's Degree in a scientific or health sciences discipline.
  • Knowledge of pharmaceutical drug development or industry-related experience preferred.
Skills and Qualifications
  • Strong problem-solving skills and ability to effectively communicate regulatory issues across multiple functions and geographies.
  • Ability to operate and manage operational requirements in a regulated environment.
  • Effective teamwork skills and ability to adapt to diverse interpersonal styles.
Working at Eli Lilly and Company

Lilly is committed to creating an inclusive work environment where everyone feels valued and supported. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

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