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- Tasks: Lead regulatory strategy and ensure compliance for pharmaceutical products across Europe.
- Company: Dynamic pharmaceutical company with a focus on innovation and collaboration.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Fast-paced environment with opportunities to mentor junior staff and drive process improvements.
- Why this job: Make a real impact in the pharmaceutical industry while working with a talented team.
- Qualifications: 7+ years in regulatory affairs with strong knowledge of European frameworks.
The predicted salary is between 43200 - 72000 £ per year.
Regulatory Affairs Manager – Speciality Medicine
A European‑focused regulatory role supporting the development, registration, and lifecycle management of speciality, orphan, paediatric, and generic medicines.
Key Responsibilities
- Develop and execute EU regulatory strategies for innovative, speciality, and complex products.
- Review non‑clinical and clinical data packages and identify gaps for regulatory submissions.
- Lead/assist with MAAs, variations, line extensions, renewals, and post‑approval commitments.
- Support regulatory interactions, including scientific advice and dossier due diligence (Modules 1–5).
- Coordinate registrations across centralised, DCP, MRP, and national procedures.
- Provide input across cross‑functional development teams and oversee documentation systems.
- Support EU launch requirements and guide junior team members where needed.
Required Experience
- Experience with ophthalmology products (eye drops, ophthalmic solutions).
- Experience leading Health authority interactions and scientific advice meetings
- Knowledge of medical devices/combination products, ideally ophthalmic.
- Proven background in injectable/sterile products and related regulatory submissions.
- Strong EU regulatory experience including MAAs, DCP/MRP, lifecycle management, and scientific advice.
- Understanding of requirements for placing medicines on the EU market.
- Hands on, proactive regulatory with authoring and submission experience
Skills & Qualifications
- Degree in Pharmacy, Life Sciences, or similar.
- Proficient with regulatory tools (eCTD publishing, CESP, MHRA Portal, etc.).
- Strong analytical, communication, and project‑management capabilities.
- Must be a proven regulatory SME in speciality pharma
Due to the nature of this roles hands-on, fast pace work, this role is not suitable for Regulatory Project Manager or those who have not directly authored dossier and lead review of both clinical and non clinical data package. All applicants must have clearly demonstrated experience with health authority interaction as an active/ leading member of meetings.
Hybrid role with weekly office presence. Unable to sponsor, candidates must hold valid Right to Work in the UK.
Regulatory Affairs Manager employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be when it comes to landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of European regulatory frameworks. We recommend having specific examples ready that showcase your experience with DCP, MRP, and post-approval activities. This will show you're not just familiar but truly engaged with the field.
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email reiterating your interest in the role can keep you top of mind. We believe this small gesture can make a big difference in the hiring process.
✨Tip Number 4
Apply through our website! We’ve made it super easy for you to submit your application directly. Plus, it shows us you’re genuinely interested in joining our team and makes tracking your application a breeze.
We think you need these skills to ace Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your experience with European regulatory frameworks and any specific projects that align with our needs. We want to see how your background fits into what we do!
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 can contribute to our team. We love seeing genuine enthusiasm for the role and our mission.
Showcase Your Experience: When detailing your experience, focus on your hands-on work with post-approval activities and regulatory strategy development. We’re looking for evidence of your ability to manage timelines and approvals in a fast-paced environment, so don’t hold back!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen to join our team at StudySmarter!
How to prepare for a job interview at Blackfield Associates
✨Know Your Regulatory Frameworks
Make sure you brush up on your knowledge of European regulatory frameworks and submission pathways. Be ready to discuss specific examples from your experience that demonstrate your understanding of DCP, MRP, and national procedures.
✨Showcase Your Strategic Thinking
Prepare to talk about how you've developed regulatory strategies for both specialty and generic products. Think of a couple of key projects where your strategic input made a difference, and be ready to explain your thought process.
✨Demonstrate Cross-Functional Collaboration
Since the role involves working with various teams, come prepared with examples of how you've successfully collaborated with internal teams and external partners. Highlight any challenges you faced and how you overcame them to ensure timely submissions.
✨Be Ready for Technical Questions
Expect questions about your hands-on experience with post-approval activities and regulatory tools like eCTD and CESP. Brush up on these topics and be ready to discuss how you've used them in your previous roles.