GMP Regulatory Compliance Specialist

Indianapolis, IN - USA

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job Summary

REQUIRED:
Bachelors required (Masters OK)
26 years experience in Pharma / Biopharma Regulatory compliance and manufacturing
Knowledge of GMP.
Experience managing authoring of CMC regulatory documents (modules 1.2 2.3 and 3)
Must have experience in Veeva Vault RIM - work within RSO ensuring data alignment submissions approvals and license compliance.
Strong authoring (GMP CMC docs Health Authority responses).
UAT experience (light involvement not validation-heavy).
Must be able to manage multiple priorities strong communication works well cross-functionally & independently.

REQUIRED: Bachelors required (Masters OK) 26 years experience in Pharma / Biopharma Regulatory compliance and manufacturing Knowledge of GMP. Experience managing authoring of CMC regulatory documents (modules 1.2 2.3 and 3) Must have experience in Veeva Vault RIM - work within RSO ensuring data alig...