Global Regulatory Compliance Specialist
3 days ago
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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 preparing CMC CTD content consistent with approved manufacturing changes, technical reports and procedural requirements.
- Partner with the CMC RA Scientist to drive the execution of submission planning for global registration and maintenance submissions.
- Triages and manages the communications between Lilly affiliates, GRA-CMC Scientists, Specialists, and the Quality/ Reg Representatives.
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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