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Regulatory Compliance Specialist II
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Cambridge, Massachusetts, United States
Location
Cambridge, Massachusetts
Posted
May 16, 2026
Commute
Local Area
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This job is in your area. Enjoy a short commute and work close to home.
Job Description
Bachelor's required (Master's OK), 2β6 years experience in Pharma / Biopharma Regulatory compliance and manufacturing,
- Knowledge of GMP. 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 is a plus (light involvement, not validation-heavy).
- Must be able to manage multiple priorities, strong communication, works well cross-functionally & independently.
- The RSO Specialist will work closely with the Manufacturing and Supply teams, and Regulatory CMC colleagues on Vaccines projects. The main focus of this position will be to support a Veeva Vault Rim project requiring previous regulatory and Veeva Vault experience. The RSO specia...