Walker Cole International
Senior Regulatory Specialist
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About This Job
Walker Cole International
Location: South East, England, United Kingdom
Work Mode: On-site
Industry: Pharmaceutical Manufacturing
Job Description
Our client, a leading global consumer healthcare organisation, is looking for a Senior Regulatory Affairs Specialist to join their EMEA Regulatory Affairs team (hybrid working).
This is a fantastic opportunity for an experienced regulatory professional to take ownership of a broad and varied portfolio, working across EU regulatory procedures and playing a key role in maintaining and expanding a well-established medicinal products portfolio.
What You'll Be Doing
- Leading on regulatory submissions in line with EU requirements (MRP/DCP), ensuring the ongoing maintenance and compliance of existing marketing authorisations
- Managing non-CMC lifecycle activities, including variations, renewals, and safety updates
- Collecting and evaluating regulatory, quality, preclinical, and clinical data to support compliance
- Liaising directly with Health Authorities, proactively seeking opportunities to expedite approvals
- Prioritising and managing multiple projects against agreed timelines
- Ensuring all assigned products remain compliant with local regulatory and quality requirements
- Supporting internal audits and inspections
- Partnering cross-functionally to manage crises and sensitive regulatory issues
- Driving local process improvements within the regulatory function
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What We're Looking For
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- A relevant Bachelor's degree or higher
- Significant experience within a Regulatory Affairs, ideally within non-prescription EU procedures (MRP/DCP)
- Proven track record managing non-CMC lifecycle activities and safety updates
- Strong attention to detail and excellent organisational skills
- Confident communicator, able to simplify complex regulatory topics for varied audiences
- A collaborative mindset with a strong sense of ownership and accountability
- Comfortable operating in a fast-paced, matrixed, multicultural environment
- Fluent in English
Desirable
- Experience within the consumer healthcare sector
- Understanding of cross-functional processes within a healthcare organisation
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