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IT Project Manager – Regulatory Compliance (Pharma & Life Sciences)

 

 

Role Overview:

 

We are seeking a detail-oriented and experienced IT Project Manager to lead projects in the Regulatory Compliance space within the Pharmaceutical and Life Sciences sector. This role will oversee IT initiatives that support regulatory submissions and compliance processes, including eCTD, CMC, labeling, RIMS, and submission lifecycle management. The ideal candidate will bring expertise in GxP, 21 CFR Part 11 compliance, and hands-on experience with platforms like Veeva Vault and other RIMS solutions.

 

 

Key Responsibilities:

 

Manage end-to-end IT projects focused on regulatory compliance and submission systems. Lead the implementation and optimization of regulatory platforms including Veeva Vault RIM, RIMS systems, and other document and submission lifecycle tools. Partner with Regulatory Affairs, Quality, and IT teams to align technology solutions with evolving compliance needs. Oversee data integrity, system validation, and audit readiness in compliance with GxP and 21 CFR Part 11. Drive improvements in document management workflows for eCTD, CMC, and labeling submissions. Develop and manage project timelines, budgets, risks, and deliverables using standard methodologies (Agile, Waterfall, or hybrid). Ensure effective change management, training, and communication across stakeholder groups. Collaborate with vendors and technology partners to deliver scalable and compliant solutions.

 

 

Qualifications:

 

Bachelor’s or Master’s degree in Computer Science, Life Sciences, Regulatory Affairs, or a related field. 10–15 years of IT project management experience within pharmaceutical regulatory operations. Strong knowledge of regulatory submission processes, including eCTD, CMC documentation, and labeling. Experience managing RIMS platforms and tools such as Veeva Vault RIM. Solid understanding of GxP, 21 CFR Part 11, and validation requirements in a regulated environment. PMP, PRINCE2, or other relevant project management certification preferred. Excellent stakeholder engagement and communication skills.

 

 

Preferred Skills:

 

Experience with data migration, system validation, or integration projects in a regulatory context. Familiarity with global regulatory requirements (FDA, EMA, etc.). Knowledge of digital submission standards and structured content authoring tools.

 

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