Regulatory Officer - Pharma

You are purpose driven. Growth minded. Ready to stretch your potential. That’s the spirit of the community you’ll find at Orbia : where the purpose to advance life around the world drives our global team of over 23,000 every single day.

From creating solutions to deliver clean water, secure food supplies and reliable information to steering material advances that power the future of green and smart cities, transportation, and healthcare, we never settle for “good enough” when there’s an opportunity to make life better. Where purpose comes to life, it changes lives. This is what we live for.

Fluor and Energy Materials, an Orbia business, is looking for a Regulatory Officer – Pharma to be based at our Thornton Science Park and Runcorn, Cheshire, UK offices.

Main Purpose

This position is responsible for ensuring that regulatory systems function as required against agreed business and user requirements, to ensure physical and electronic controls (where applicable) aid in maintaining pharma product quality, integrity and reliability.

This position will work closely with Regulatory, QA, QC and IT personnel to support current and future product offerings and strive to identify all product defects before release. Assist in all aspects of developing, validating and deploying regulatory procedures.

Support improvement projects from a regulatory perspective, meeting all aspects of current regulatory legislation in a medical product context.

Main Responsibilities

• Support the Regulatory Affairs Manager in day-to-day regulatory tasks.
• Support the validation / utilization of GxP software to automate regulatory procedures (where applicable).
• Make recommendations for new equipment, system or service.
• Management of vendors / contractors where applicable.
• Assess proposed changes to working systems to determine the impact upon the qualification status of the related equipment to determine additional needs for validation.
• Review and post approval of qualification protocols / summary reports for Quality Systems from a regulatory perspective.
• Critical review of validation protocols and reports to meet global legislative (i.e. Part 11 / Annex 11 requirements for CFR) review.
• Facilitate ongoing cGMP promotion / governance to GxP related personnel.

Qualifications

Knowledge / Experience Required

Behaviours that can help you succeed at Orbia

We welcome purpose-driven dreamers, doers, and builders, recognizing that it takes difference to make a difference. If you’re ready to bring your skills, talents, and perspective to moving your career, the company, people, and the planet forward, we’d like to hear from you.

We believe that every voice matters; every community deserves respect; and every challenge is an opportunity and united by empathy, we are stronger for our different perspectives. We are dedicated to building a more diverse, inclusive, and equitable workplace that supports the needs of all our employees regardless of their role, location, identity, and background.