Senior Regulatory Specialist

About This Job Walker Cole International

Location:

South East, England, United Kingdom

Work Mode:
On-site

Industry: Pharmaceutical Manufacturing

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.

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

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 audiencesA collaborative mindset with a strong sense of ownership and accountability

Comfortable operating in a fast-paced, matrixed, multicultural environment

Fluent in English

Experience with in the consumer healthcare sector

Understanding of cross-functional processes within a healthcare organisation