Life Sciences Regulatory Expert
4 days ago
We're looking for a highly skilled Life Sciences Regulatory Expert 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:
- Responsible for triage of Lilly affiliate inquiries and requests and when necessary, consults with CMC RA Scientist for guidance in effort to prepare responses to questions.
- Partners with the CMC RA Scientist to drive the execution of submission planning for global registration and maintenance submissions.
- Provides regulatory expertise to support clinical studies and manufacturing process changes for development and marketed products.
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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