At a Glance
- Tasks: Lead regulatory strategies for innovative oncology and rare disease products.
- Company: Exciting pharmaceutical business focused on cutting-edge treatments.
- Benefits: Competitive salary, career progression, and a dynamic work environment.
- Other info: Join a culture of compliance and continuous improvement while mentoring junior staff.
- Why this job: Make a real impact in global health by guiding life-saving therapies.
- Qualifications: Experience in regulatory affairs with strong leadership and communication skills.
The predicted salary is between 43200 - 72000 £ per year.
Walker Cole International is supporting a global consumer healthcare organisation in the search for a Regulatory Affairs Lead to join its Europe North Regulatory Affairs and Category Strategy team.
This role combines UK & Ireland regulatory leadership (post-marketing & compliance) with global category regulatory strategy across medicines, cosmetics, and medical devices, supporting innovation from concept to launch.
Key Responsibilities:
• Lead UK & Ireland regulatory activities ensuring compliance across medicines, medical devices, and cosmetics
• Manage post-marketing lifecycle activities including variations, renewals, safety updates, and change control
• Act as key contact for regulatory authorities (e.g. MHRA) and external stakeholders
• Lead and develop a Regulatory Affairs team within the cluster
• Define regulatory strategy for category innovation projects across global markets
• Support product development from ideation to launch (classification, pathways, data requirements, claims)
• Lead regulatory input into stage-gate processes and cross-functional innovation teams
• Manage regulatory submissions (dossiers, labelling, PIFs, artwork) and EU procedures where applicable
• Conduct due diligence and support external opportunity assessments and acquisitions
About You
• 8+ years’ Regulatory Affairs experience in consumer healthcare / pharma environment
• Strong expertise in UK OTC and post-marketing lifecycle management
• Experience across medicines and exposure to medical devices and/or cosmetics
• Proven ability to lead regulatory strategy and cross-functional innovation projects
• Experience working with health authorities (e.g. MHRA) and EU or international markets
• Strong leadership, communication, and stakeholder management skills
• Strategic mindset with strong execution and attention to detail
Regulatory Affairs / Regulatory Strategy / OTC Medicines / Medical Devices / Cosmetics / UK Regulatory Affairs / MHRA / Lifecycle Management / Variations / Renewals / Change Control / EU MDR / Innovation / Submissions / Category Management / Consumer Healthcare / UK & Ireland / International Markets/110432/111827
Senior Manager Regulatory Affairs in Slough 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.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager Regulatory Affairs in Slough
✨Tip Number 1
Network like a pro! Reach out to industry contacts on LinkedIn or at events. We all know that sometimes it’s not just what you know, but who you know that can help you land that Senior Regulatory Affairs Manager role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of global regulatory frameworks. We recommend having a few examples ready that showcase your experience with FDA, EMA, and ICH regulations. This will show you're the right fit for the job!
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We suggest mentioning something specific from your conversation to make it personal.
✨Tip Number 4
Apply through our website! We’ve got loads of resources to help you prepare and stand out. Plus, it shows you’re genuinely interested in joining our innovative team focused on oncology and rare diseases.
We think you need these skills to ace Senior Manager Regulatory Affairs in Slough
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your experience in regulatory affairs, especially in oncology and rare diseases. We want to see how your background aligns with the role, so don’t be shy about showcasing your relevant skills and achievements!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how your leadership experience can contribute to our innovative team. Keep it concise but impactful – we love a good story!
Showcase Your Communication Skills:As a Senior Regulatory Affairs Manager, strong communication is key. In your application, highlight examples where you've effectively communicated with global health authorities or cross-functional teams. This will show us you can handle the role's demands.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about our company culture and values!
How to prepare for a job interview at Walker Cole International
✨Know Your Regulatory Frameworks
Make sure you brush up on your knowledge of global regulatory frameworks like FDA, EMA, and ICH. Be prepared to discuss how these regulations impact product strategy and lifecycle management, as this will show your expertise and readiness for the role.
✨Showcase Your Leadership Skills
As a Senior Manager, you'll need to demonstrate your leadership experience. Think of specific examples where you've successfully led teams or projects, especially in a matrixed environment. This will help convey your ability to mentor junior staff and foster a culture of compliance.
✨Prepare for Technical Questions
Expect technical questions about regulatory submissions like INDs, CTAs, and MAAs. Familiarise yourself with the processes involved in preparing high-quality submissions, and be ready to discuss any challenges you've faced and how you overcame them.
✨Stay Updated on Global Regulations
Regulatory affairs is constantly evolving, so it's crucial to stay informed about changes in global regulations. Be prepared to discuss recent developments and how they might affect the pharmaceutical industry, particularly in oncology and rare diseases.
