Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Manage regulatory affairs for clinical trials and access programs, ensuring compliance and timely delivery.
- Company: Join WEP Clinical, a mission-driven organisation transforming lives through innovative clinical research.
- Benefits: Enjoy private healthcare, pension schemes, paid leave, and wellness initiatives.
- Why this job: Be part of a dynamic team making a real difference in patients' lives while fostering innovation.
- Qualifications: Bachelor's degree and 3+ years in regulatory affairs; strong analytical and communication skills required.
- Other info: WEP Clinical values diversity, equity, and inclusion, offering a supportive work environment.
The predicted salary is between 36000 - 60000 £ per year.
5 days ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
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:
As a Project Manager, you will play a vital role in getting medicines to patients who have exhausted all viable options. You will be responsible for setting up, implementing, and managing individual Expanded Access Programs.
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:
As a Project Manager, you will play a vital role in getting medicines to patients who have exhausted all viable options. You will be responsible for setting up, implementing, and managing individual Expanded Access Programs.
The Ideal Candidate:
- Innovative
- Strategic
- Data driven
- Analytical
- Detail Oriented
- Problem Solver
Principal Duties and Responsibilities:
- Serve as the main point of contact for ongoing Clinical Trial, EAP, CUP, and PA-NPP Regulatory Affairs matters (US, Europe, and ROW), leveraging and interpreting existing intelligence sources and databases to provide pragmatic advice and guidance to WEP colleagues and clients and drive the completion of related project activities.
- Develop robust regulatory strategies to ensure compliant and timely access to products compliant with the destination country\’s regulatory requirements.
- Provide regulatory support to sites requiring specific regulatory guidance to facilitate product supply.
- Maintain accurate and up-to-date regulatory documentation and databases specific to the projects.
- Manage changes impacting your projects from a regulatory perspective, clearly communicating the impact and working with the key stakeholders to ensure completion of critical activities to avoid disruption.
- Participate in project kick-off and maintenance meetings, providing status updates and confidently addressing any queries relating to regulatory matters.
- Support the Business Development team and assist in client bid-related activities such as budget development, proposals and bid defences.
- Oversee domestic licenses (US, UK, and IE) in collaboration with key departments (Quality and Supply Chain) to ensure regulated activities are within the scope of existing licenses. Where required, put in relevant variations to the Health Authorities, and ensure risks and timelines for variations are understood and can be met.
- Lead and manage the preparation, compilation, and submission of regulatory applications for related projects (e.g., CUP/EAP and/or CT applications) to relevant Health Authorities (e.g., MHRA, ANSM, FDA, national competent authorities), on time.
- Coordinate with internal teams (Medical Affairs, Supply Chain, Quality, Project Management) to gather PAGE 2 OF 4 necessary documentation and data for submissions within agreed timelines.
- Manage regulatory inquiries and correspondence from Health Authorities regarding these projects, ensuring questions can be addressed.
- Proactively address potential issues and risks before submission to Health Authorities, and have appropriate risk mitigation strategies in place to address the risks.
- Serve as the primary Regulatory Affairs point of contact for internal stakeholders involved in related projects, providing expert regulatory guidance and solutions.
- Collaborate with key stakeholders, such as Medical Affairs, Project Management, Clinical Operations, Quality, Pharmacovigilance, and Supply Chain, to ensure seamless project coordination and execution.
Qualifications:
- Bachelor\’s degree (legal, life sciences, or scientific equivalent preferred)
- 3+ 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 map it onto projects, identifying the critical path, timelines, risks and proposing solutions.
- Proven ability to handle multiple projects and priorities in a fast-paced environment.
- Strong problem-solving abilities, being proactive and solution-oriented
- Strong organisational skills and attention to detail
- Computer literacy and proficient in Microsoft Office
- Ability to handle confidential information with complete discretion
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
What Sets Us Apart:
WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.
We\’re Committed to Our Team:
WEP has many initiatives to encourage wellness, growth, development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events and all that we do to support our employees.
We\’re Committed to DEI:
At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone\’s unique identities.
Our services include:
Access Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialisation
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.
Seniority level
-
Seniority level
Mid-Senior level
Employment type
-
Employment type
Full-time
Job function
-
Job function
Legal
-
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at WEP Clinical by 2x
Senior Regulatory Affairs Specialist – EU- Remote
Regulatory Affairs Senior Specialist (m/f/d)
Senior Manager, Regulatory Science Late-Stage Programs
London, England, United Kingdom 1 month ago
Regulatory Affairs Manager CMC (Global) – Based Anywhere in Europe
Hatfield, England, United Kingdom 23 hours ago
Northern Ireland, United Kingdom 2 weeks ago
Business Development Manager – Regulatory Compliance
Fraud Change and Regulatory Engagement Manager
Regulatory Compliance Manager (Wealth & Trading)
Manager – Solution Consulting Regulatory / Pharmacovigilance
London, England, United Kingdom 2 weeks ago
Senior Clinical Project Manager – Expanded Access Programs
Regulatory Affairs Associate – 6 Months FTC
London, England, United Kingdom 5 days ago
Regulatory Affairs Associate – 6 Months FTC
London, England, United Kingdom 3 days ago
Regulatory Affairs Specialist (Orthopaedic Reconstruction)
London, England, United Kingdom 6 days ago
Regulatory Affairs Specialist (Orthopaedic Reconstruction)
Regulatory Affairs Specialist (Sports Medicine)
Department Leader Regulatory Affairs – IVD\’s
Manager – Solution Consulting Regulatory / Pharmacovigilance
London, England, United Kingdom 1 month ago
London, England, United Kingdom 1 week ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Regulatory Affairs Manager employer: WEP Clinical
Contact Detail:
WEP Clinical Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨Tip Number 1
Familiarise yourself with the latest EU and FDA regulations, as well as the specific requirements for Expanded Access Programs. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the regulatory field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience with unlicensed supply and clinical trials. Engaging in conversations can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've developed regulatory strategies or managed multiple projects in a fast-paced environment. Highlighting your problem-solving skills and ability to communicate effectively will set you apart.
✨Tip Number 4
Research WEP Clinical's mission and values thoroughly. Understanding their commitment to patient access and clinical research will allow you to align your answers during interviews with their organisational goals, showcasing your genuine interest in the position.
We think you need these skills to ace Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, particularly any work with clinical trials or expanded access programmes. Use keywords from the job description to demonstrate your fit for the role.
Craft a Compelling Cover Letter: In your cover letter, express your passion for improving patient outcomes and your understanding of regulatory frameworks. Mention specific examples of how you've successfully navigated regulatory challenges in the past.
Showcase Your Analytical Skills: Provide examples in your application that showcase your analytical skills and problem-solving abilities. Discuss how you've used data to inform regulatory strategies or overcome obstacles in previous roles.
Highlight Collaboration Experience: Since the role involves working with various stakeholders, emphasise your experience in collaborative projects. Detail how you’ve effectively communicated and coordinated with different teams to achieve regulatory compliance.
How to prepare for a job interview at WEP Clinical
✨Understand Regulatory Frameworks
Familiarise yourself with the global regulatory frameworks, especially EU and FDA regulations. Be prepared to discuss how these regulations impact the role and your previous experiences in navigating them.
✨Showcase Problem-Solving Skills
Prepare examples of how you've proactively addressed regulatory challenges in past projects. Highlight your analytical skills and ability to develop robust regulatory strategies that ensure compliance.
✨Communicate Effectively
Practice articulating complex regulatory matters clearly and confidently. You may be asked to explain how you would communicate project-related risks or updates to both clients and internal stakeholders.
✨Demonstrate Organisational Skills
Be ready to discuss how you manage multiple projects and priorities in a fast-paced environment. Provide specific examples of how your attention to detail has contributed to successful project outcomes.
