Position Details
About this role
Senior Specialist to oversee RPP tools and the GRACS Digital Strategy within Regulatory Planning and Publishing, partnering with DIS/RIIM/IT to implement new tools and drive change management. This role focuses on ensuring data-connected, compliant, and efficient regulatory workflows.
Key Responsibilities
- Oversee enterprise-wide digital tools for Regulatory Planning and Publishing (RPP) and aligning with GRACS Digital Strategy
- Assess and adopt new tools (Microsoft Power Platform, SharePoint, Generative AI) and manage tool retirements
- Lead change management communications and training for tool rollouts
- Enhance data quality and operational efficiency across RPP tools
- Mentor RPP personnel and conduct testing/training on tools
Technical Overview
Scope includes enterprise digital tools for Regulatory Planning and Publishing, with exposure to Microsoft Power Platform, SharePoint, Generative AI, Python, ALM/SDLC, and PMP-aligned project methodologies. Requires cross-functional collaboration across regulatory, IT, and quality domains.
Ideal Candidate
The ideal candidate is a senior-level project/program management professional with pharmaceutical regulatory affairs experience and strong cross-functional leadership. They should be proficient with Microsoft Power Platform and SharePoint, capable of guiding tool adoption within RPP, and skilled at change management and training related to GRACS Digital Strategy.
Must-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Certifications
Preferred
Industry & Role
Keywords for Your Resume
Deal Breakers
No pharmaceutical regulatory affairs experience, Lack of experience with regulatory submissions or regulatory compliance
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