REQUIRED:
•             Bachelors required (Master’s OK),
•             2–6 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.