Global Regulatory Compliance Specialist

3 days ago


Cork, Cork, Ireland Eli Lilly and Company Full time

Eli Lilly and Company is committed to helping individuals with disabilities participate in the workforce and ensuring equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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.

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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