CMC Submission Manager

5 days ago


Cork, Cork, Ireland Eli Lilly and Company Full time

We are seeking a highly skilled CMC Submission Manager to join our team. As a key member of our Global Regulatory Affairs department, you will be responsible for leading CMC submission management processes, providing regulatory expertise, and collaborating with cross-functional teams to ensure compliance with global regulations.

About Us:

We are a global healthcare leader that unites caring with discovery to make life better for people around the world. 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.

Job Summary:

The CMC Regulatory Associate works within regulations to expedite the registration and lifecycle maintenance of products. This is accomplished by a strong working knowledge of internal procedures, guidance's, and regulatory precedence.

Responsibilities:

  • Leads CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards.
  • Partners with CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products.
  • Implements and interprets global regulations and guidance's into submission processes and publishing standards to ensure final document content and structure are aligned with local regulatory requirements.

Requirements:

  • Bachelor's Degree in a scientific or health sciences discipline.
  • Knowledge of pharmaceutical drug development or industry-related experience preferred.


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