At a Glance
- Tasks: Drive impactful solutions in regulatory affairs for clinical trials and patient access programs.
- Company: Join WEP Clinical, a mission-driven organisation transforming lives through clinical research.
- Benefits: Enjoy private healthcare, pension plans, paid leave, and volunteer days.
- Other info: Collaborative culture focused on innovation and continuous improvement.
- Why this job: Make a real difference in patients' lives while advancing your career in a dynamic environment.
- Qualifications: 5+ years in regulatory affairs with strong analytical and communication skills.
The predicted salary is between 50000 - 65000 £ per year.
Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring ideas that make a real difference. Be part of a mission-driven organisation dedicated to advancing clinical research and transforming lives.
Role Objectives
The WEP Clinical Regulatory Affairs Manager plays a pivotal role in developing, executing and supporting the regulatory strategy with respect to the various projects managed by WEP Clinical (primarily Post-Approval Named Patient Programs, Expanded Access Programs, Compassionate Use Programs, and Clinical Trials). The Regulatory Affairs Manager will be responsible for managing regulatory submissions, ensuring compliance, and providing expert regulatory guidance to enable timely access to medicines for patients with urgent unmet medical needs across various global markets. The Regulatory Affairs Manager will be a key contributor to WEP Clinical projects, working closely with cross-functional teams to navigate complex and unique regulatory pathways.
The Ideal Candidate
- Innovative
- Strategic
- Data driven
- Analytical
What You’ll Do
- Serve as the primary Regulatory Affairs contact for Clinical Trials, EAP, CUP, and PA-NPP programs across the US, Europe, and Rest of World, providing strategic guidance to internal teams and clients.
- Develop and implement regulatory strategies to ensure compliant, timely product access in accordance with destination country requirements.
- Lead the preparation, compilation, and submission of regulatory applications to Health Authorities, managing inquiries and correspondence through approval.
- Oversee domestic licenses in the US, UK, and Ireland, including managing variations and collaborating with Quality and Supply Chain to ensure regulated activities remain in scope.
- Maintain accurate regulatory documentation, intelligence trackers, and project databases, proactively managing regulatory changes and associated risks.
- Partner cross-functionally with Medical Affairs, Clinical Operations, Project Management, Quality, Pharmacovigilance, and Supply Chain to support seamless project execution.
- Provide regulatory support to investigational sites and contribute expert guidance during project kick-offs, maintenance meetings, and client discussions.
- Support Business Development activities, including proposal development, budgeting, and participation in bid defenses.
- Identify potential regulatory risks early and implement mitigation strategies to prevent delays or disruptions.
- Contribute to team leadership and operational excellence, including line management where applicable, SOP development, Health Authority relationship management, and continuous process improvement initiatives.
What You’ll Need
- Bachelor’s degree (legal, life sciences, or scientific equivalent preferred).
- 5+ years of broad regulatory experience.
- Familiarity with global regulatory frameworks, in particular EU and FDA regulations.
- Understanding and expertise of unlicensed supply (e.g. Expanded Access, Compassionate Use, Named Patient) preferred.
- Experience in developing regulatory strategies.
- Ability to communicate within a project setting either to clients or internal key stakeholders, effectively articulate project related matters, risks or updates.
- Strong analytical skills to practically and pragmatically apply regulatory intelligence and to map it onto projects, identifying the critical path, timelines, risks and propose solutions.
- Proven ability to handle multiple projects and priorities in a fast-paced environment.
- Strong problem-solving abilities, being proactive and solution oriented.
- Strong organizational skills and attention to detail.
- Computer literacy and proficient in Microsoft Office.
- Ability to handle confidential information with complete discretion.
- The employee must be able to remain in a stationary position for extended periods.
What We Offer
- Private healthcare insurance.
- Long-term illness cover.
- Death in service cover.
- Salary sacrifice pension.
- Annual leave.
- Paid maternity & paternity leave.
- Volunteer day.
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment. WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
Regulatory Affairs Manager in London employer: WEP Clinical Ltd
At WEP Clinical, we pride ourselves on being an innovative and mission-driven organisation that values collaboration and creativity. Our supportive work culture fosters professional growth, offering employees opportunities to lead impactful projects in the regulatory landscape while ensuring timely access to vital medicines for patients in need. With comprehensive benefits including private healthcare, generous leave policies, and a commitment to diversity and inclusion, WEP Clinical is an exceptional employer for those seeking meaningful and rewarding careers in clinical research.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Manager in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field and let them know you're on the lookout for new opportunities. You never know who might have the inside scoop on a job opening or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching WEP Clinical and understanding their mission. Be ready to discuss how your experience aligns with their goals, especially in navigating complex regulatory pathways. Show them you’re not just another candidate, but someone who truly gets what they do!
✨Tip Number 3
Practice your pitch! You want to be able to clearly articulate your regulatory experience and how it can benefit WEP Clinical. Keep it concise and impactful – think of it as your personal brand statement that highlights your strengths.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in being part of our mission-driven team at WEP Clinical.
We think you need these skills to ace Regulatory Affairs Manager in London
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Regulatory Affairs Manager role. Highlight your relevant experience in regulatory submissions and compliance, and show how your skills align with our mission at WEP Clinical.
Showcase Your Analytical Skills:We love data-driven candidates! In your application, emphasise your analytical abilities and how you've used them to navigate complex regulatory pathways. This will demonstrate your fit for the role and our innovative culture.
Be Clear and Concise:When writing your application, keep it straightforward. Use clear language to articulate your experiences and achievements. We appreciate candidates who can communicate effectively, especially in a project setting.
Apply Through Our Website:Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for this exciting opportunity at WEP Clinical.
How to prepare for a job interview at WEP Clinical Ltd
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of global regulatory frameworks, especially EU and FDA regulations. Be ready to discuss how your experience aligns with the specific requirements of the role, particularly around Post-Approval Named Patient Programs and Compassionate Use.
✨Showcase Your Strategic Thinking
Prepare examples that demonstrate your ability to develop and implement regulatory strategies. Think about times when you've successfully navigated complex regulatory pathways and how you can apply that experience to WEP Clinical's projects.
✨Communicate Clearly and Confidently
Practice articulating project-related matters, risks, and updates in a clear and concise manner. You’ll need to communicate effectively with both internal teams and clients, so consider rehearsing common scenarios or questions you might face during the interview.
✨Be Proactive About Problem-Solving
Think of instances where you've identified potential regulatory risks early and implemented mitigation strategies. Highlight your strong analytical skills and how they’ve helped you manage multiple projects in fast-paced environments, as this will resonate well with the team at WEP Clinical.
