At a Glance
- Tasks: Lead regulatory submissions and ensure compliance for a diverse portfolio of medicinal products.
- Company: Join a leading global consumer healthcare organisation with a hybrid working model.
- Benefits: Enjoy competitive salary, flexible working, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on process improvement and career development.
- Why this job: Make a real impact in healthcare by driving regulatory excellence and innovation.
- Qualifications: Bachelor's degree and significant experience in Regulatory Affairs, especially in EU procedures.
The predicted salary is between 59400 - 72600 £ per year.
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.
What We're Looking For
- 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.
Senior Regulatory Specialist employer: Walker Cole International
Walker Cole International is an exceptional employer that prioritises a dynamic and patient-focused work culture, making it an ideal place for professionals in Regulatory Affairs. With a commitment to employee growth and development, the company offers unique opportunities to engage with international markets while ensuring compliance and driving product lifecycle management. Located in a vibrant industry hub, employees benefit from collaborative teamwork and the chance to make a meaningful impact in the pharmaceutical sector.
