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- Tasks: Lead regulatory submissions and mentor junior team members in a dynamic pharmaceutical environment.
- Company: Growing pharmaceutical organisation focused on innovative products.
- Benefits: Competitive salary, professional development, and opportunities for career advancement.
- Other info: Collaborative culture with exposure to international markets.
- Why this job: Make a real impact in regulatory affairs while shaping the future of healthcare.
- Qualifications: 5+ years in EU/UK Regulatory Affairs with strong CMC expertise.
The predicted salary is between 60000 - 80000 £ per year.
We are supporting a growing pharmaceutical organisation seeking an experienced Regulatory Affairs Manager to support EU and UK regulatory activities across generic and speciality products. This is a hands‑on role requiring strong CMC expertise, end‑to‑end ownership of submissions, and the ability to operate independently while mentoring junior team members.
Key Responsibilities:
- Prepare, review, and manage Marketing Authorisation Applications (MAAs) via National, DCP, MRP, and Centralised procedures
- Lead CMC (Module 3) and Module 2 (QOS) authoring, review, and Health Authority responses
- Manage lifecycle activities, including variations, renewals, PSURs, and post‑approval commitments
- Perform dossier due diligence, gap analysis, and regulatory feasibility assessments
- Maintain and update SmPCs, PILs, labelling, and regulatory documentation
- Act as a key point of contact with MHRA, EMA, and EU competent authorities
- Support regulatory strategy development for new and in‑licensed products
- Provide regulatory input to cross‑functional teams (CMC, Quality, Supply, Clinical)
- Mentor and guide junior regulatory colleagues as required
- Maintain regulatory systems, archives, and ensure inspection readiness
Required Experience & Skills:
- Degree in Life Sciences, Pharmacy, or related discipline
- 5+ years’ experience in EU/UK Regulatory Affairs within pharmaceuticals
- Strong hands‑on experience with DCP/MRP procedures
- Proven CMC authorship experience (Module 3 & QOS essential)
- Experience across generics, hybrids, and well‑established use products
- Strong understanding of EU regulatory frameworks and lifecycle management
- Ability to operate independently from day one
- Confident communicator with Health Authorities and internal stakeholders
- Experience mentoring or supporting junior team members
Desirable Experience:
- Exposure to ROW markets (e.g. Middle East, Canada, China)
- Experience with manufacturing site transfers and CMO changes
- Familiarity with regulatory databases and eCTD publishing tools
Regulatory Affairs Manager /Senior Manager in London employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager /Senior Manager in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those in regulatory affairs. Attend industry events or webinars to meet potential employers and get your name out there.
✨Tip Number 2
Prepare for interviews by brushing up on your CMC expertise and regulatory frameworks. Be ready to discuss your hands-on experience with MAAs and lifecycle management, as these are key areas they'll want to hear about.
✨Tip Number 3
Showcase your mentoring skills! If you’ve guided junior colleagues before, make sure to highlight this during interviews. Employers love candidates who can lead and develop their teams.
✨Tip Number 4
Don’t forget to apply through our website! We have loads of opportunities that might just be the perfect fit for you. Plus, it’s a great way to ensure your application gets seen by the right people.
We think you need these skills to ace Regulatory Affairs Manager /Senior Manager in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your experience with MAAs, CMC expertise, and any mentoring you've done. We want to see how your background fits our needs!
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 skills align with our requirements. We love seeing genuine enthusiasm for the role.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements in previous roles. Whether it's successful submissions or mentoring junior colleagues, we want to know how you’ve made an impact!
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 from us!
How to prepare for a job interview at Blackfield Associates
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of EU and UK regulatory frameworks. Be ready to discuss specific procedures like DCP and MRP, as well as your hands-on experience with CMC authoring. This will show that you’re not just familiar with the theory but have practical insights to share.
✨Showcase Your Leadership Skills
Since this role involves mentoring junior colleagues, be prepared to talk about your leadership style. Share examples of how you've guided team members in the past, especially in regulatory affairs. Highlight any successful projects where your mentorship made a difference.
✨Prepare for Technical Questions
Expect to dive deep into technical aspects during the interview. Prepare to discuss your experience with Marketing Authorisation Applications and lifecycle management activities. Practise articulating your thought process behind regulatory feasibility assessments and gap analyses.
✨Communicate Confidently
As a key point of contact with health authorities, your communication skills are crucial. Practise clear and concise responses to potential questions. Think about how you can convey complex regulatory concepts in an understandable way, demonstrating your ability to engage with both internal teams and external stakeholders.