Regulatory Affairs Project Specialist - System Implementation

at  Ecolab

Ecolab, Purolite Resins, the world leader in resin-based separation, purification and extraction technology, is seeking a Senior Regulatory Affairs Specialist.
We manufacture products which help our customers around the globe, mainly in pharmaceutical and life science sectors, with technology which are critical to safe manufacture of their products. It’s an exciting business which helps make the world cleaner, safer and healthier.
Are you passionate about regulatory compliance, business growth and project management? We are looking for a dynamic Senior Regulatory Affairs Specialist to lead our BPT divisional Regulatory business readiness activities for the SAP Global implementation. This is a fantastic opportunity to make a significant impact on our organization by ensuring compliance with all relevant regulatory requirements and standards.

• Lead the Regulatory business readiness activities for SAP Global implementation.
• Work with Regulatory teams, such as Product Safety, Transport Classification, and Registration & Approvals during SAP EHS implementation to ensure processes to be compliant with all relevant regulatory requirements and standards.
• Lead in setting up processes within SAP/specification system for highly regulated Pharma products, including Active Pharmaceutical Ingredients (API).
• Manage and coordinate project activities to ensure timely and successful implementation.
• Collaborate with cross-functional teams to align regulatory strategies with business objectives.
• Monitor and report on project progress, identifying and mitigating risks as necessary.
• Provide regulatory guidance and support to project teams throughout the implementation process.
• Partner with various functions such as the Specification team, Quality, Marketing, Supply Chain, and others to identify processes and appropriate review steps for SAP implementation.