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- Tasks: Lead regulatory activities for innovative pharmaceutical products across the EU and UK.
- Company: Dynamic pharmaceutical organisation focused on growth and innovation.
- Benefits: Competitive salary, career development, and a chance to mentor future leaders.
- Other info: Join a collaborative team and enjoy opportunities for professional growth.
- Why this job: Make a real impact in the pharmaceutical industry while shaping regulatory strategies.
- Qualifications: 5+ years in Regulatory Affairs with strong CMC expertise and communication skills.
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
Senior Manager/Director of Regulatory Affairs in London employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager/Director of Regulatory Affairs 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
Show off your expertise! Prepare a portfolio showcasing your CMC authorship and successful submissions. This will help you stand out during interviews and demonstrate your hands-on experience.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your communication skills, especially when discussing your experience with Health Authorities and cross-functional teams.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of opportunities that match your skills. Plus, it’s a great way to ensure your application gets noticed by the right people.
We think you need these skills to ace Senior Manager/Director of Regulatory Affairs in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Senior Manager/Director of Regulatory Affairs. Highlight your experience with MAAs, CMC authoring, and any relevant regulatory frameworks. We want to see how your background aligns with our needs!
Showcase Your Expertise: In your cover letter, don’t shy away from showcasing your hands-on experience with DCP/MRP procedures and your ability to mentor junior colleagues. We love seeing candidates who can lead and inspire others in the regulatory space.
Be Clear and Concise: When writing your application, keep it clear and concise. Use bullet points where possible to make your achievements stand out. We appreciate straightforward communication, especially when it comes to complex topics like regulatory affairs.
Apply Through Our Website: Finally, make sure to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. We can’t wait to see what you bring to the table!
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, MRP, and Centralised applications. Showing that you’re well-versed in these areas will demonstrate your expertise and confidence.
✨Showcase Your CMC Experience
Prepare to talk about your hands-on experience with CMC authoring, especially Module 3 and QOS. Bring examples of past submissions you've managed and how you handled any challenges. This will highlight your end-to-end ownership skills and problem-solving abilities.
✨Mentorship Matters
Since mentoring junior colleagues is part of the role, think of instances where you've guided others. Share specific examples of how you’ve supported team members in their development. This shows you’re not just a lone wolf but a team player who values collaboration.
✨Engage with Cross-Functional Teams
Be prepared to discuss how you’ve worked with cross-functional teams in the past. Highlight your ability to provide regulatory input to various departments like Quality and Clinical. This will show that you can communicate effectively and contribute to broader company goals.