At a Glance
- Tasks: Lead regulatory strategy and ensure successful outcomes for pharmaceutical products across Europe.
- Company: Join a leading pharmaceutical company with a focus on innovation and collaboration.
- Benefits: Competitive hourly rate, flexible hybrid work, and the chance to shape industry standards.
- Other info: Opportunity for professional growth in a dynamic, international environment.
- Why this job: Make a real impact in healthcare by driving regulatory success for vital products.
- Qualifications: Degree in life sciences and strong experience in European Regulatory Affairs required.
The predicted salary is between 56000 - 68000 £ per year.
Location: Maidenhead/Remote (hybrid)
Duration: 12 months initial (FOUR days per week / 0.8 FTE)
Rate: £70-85 per hour (based on experience)
We are working with a leading pharmaceutical company who are seeking an experienced Senior Manager, Regulatory Affairs to shape and drive regulatory strategy across the Europe Area. This high-impact role will work across development and marketed products, partnering closely with global teams, affiliates and health authorities to ensure successful regulatory outcomes.
Key Responsibilities- Lead the development and implementation of regulatory strategies and risk assessments for assigned products across the Europe Area
- Represent regional regulatory requirements within global regulatory project teams to ensure appropriate consideration in global strategy
- Collaborate with affiliate Regulatory Affairs teams to guide submissions, health authority interactions and life-cycle management activities
- Assess scientific data for regulatory submissions, identify gaps, and develop mitigation strategies to support approvals
- Monitor evolving European legislation and lead the development of regulatory responses and policy implementation
- Degree in pharmacy, biology, chemistry, pharmacology, or related life sciences discipline
- Strong experience in European Regulatory Affairs, including centralised, MRP/DCP and national procedures
- Proven track record leading regulatory activities for development products (e.g., scientific advice, PIP)
- Effective communicator able to work across complex international and matrixed environments
- Strong leadership, organisational skills and ability to work independently with minimal supervision
To apply: SRG would be delighted to discuss this opportunity further with you. Please click to apply or contact Theo Charles for more details.
Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy.
Senior Regulatory Affairs Lead - Europe (Hybrid/Remote) in Thatcham employer: Carbon 60
Join a leading pharmaceutical company that prioritises employee growth and development, offering a hybrid work model that promotes work-life balance. With a strong focus on collaboration and innovation, you'll have the opportunity to shape regulatory strategies across Europe while working alongside global teams in a supportive and dynamic environment. Enjoy competitive rates and the chance to make a meaningful impact in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Affairs Lead - Europe (Hybrid/Remote) in Thatcham
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those in regulatory affairs. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of European regulatory frameworks. We want you to be able to discuss how you've navigated complex regulations in past roles. Show them you're the expert they need!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Use our website to find roles that excite you and match your skills. Tailor your approach to each company’s culture!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can keep you top of mind. Share a relevant insight from your conversation to reinforce your interest and expertise. It shows you’re proactive and engaged!
We think you need these skills to ace Senior Regulatory Affairs Lead - Europe (Hybrid/Remote) in Thatcham
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Regulatory Affairs role. Highlight your experience in European Regulatory Affairs and any relevant projects you've led. We want to see how your background aligns with the job description!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Mention specific experiences that relate to the responsibilities listed, and don’t forget to show your enthusiasm for working with us at StudySmarter.
Showcase Your Communication Skills:As an effective communicator, it's crucial to demonstrate this in your application. Use clear and concise language, and make sure to highlight any experience you have working in complex international environments. We love seeing strong communication skills!
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you don’t miss out on any important updates. Plus, it’s super easy to do!
How to prepare for a job interview at Carbon 60
✨Know Your Regulatory Stuff
Make sure you brush up on the latest European regulatory guidelines and procedures. Familiarise yourself with centralised, MRP/DCP, and national procedures, as well as any recent changes in legislation. This will show that you're not just experienced but also proactive about staying current.
✨Showcase Your Leadership Skills
Prepare examples of how you've led regulatory activities in the past. Think about specific projects where you guided teams or made strategic decisions. Being able to articulate your leadership style and successes will help demonstrate your fit for this high-impact role.
✨Communicate Clearly and Confidently
Since effective communication is key in this role, practice articulating your thoughts clearly. You might be asked to explain complex regulatory concepts, so being able to simplify these for different audiences will be crucial. Consider doing mock interviews to refine your delivery.
✨Prepare for Scenario Questions
Expect questions that assess how you would handle specific regulatory challenges. Think through potential scenarios related to product submissions or health authority interactions, and prepare your thought process on how you'd approach these situations. This will showcase your problem-solving skills and strategic thinking.
