At a Glance
- Tasks: Lead regulatory strategy for innovative pharmaceutical products and ensure compliance across the EU/UK.
- Company: Dynamic pharmaceutical organisation focused on speciality products and innovation.
- Benefits: Competitive salary, career growth opportunities, and a collaborative work environment.
- Other info: Join a team that values flexibility, teamwork, and effective communication.
- Why this job: Make a real impact on healthcare by shaping regulatory pathways for cutting-edge therapies.
- Qualifications: 5-10 years in regulatory affairs with a strong understanding of EU/UK requirements.
The predicted salary is between 60000 - 80000 £ per year.
Blackfield Associates are supporting a growing pharmaceutical organisation seeking a Senior Regulatory Affairs Manager to lead EU/UK regulatory strategy and due diligence across a portfolio of speciality products. This role sits at the core of decision‑making for late‑stage assets (Phase II/III) and in‑licensing opportunities, with direct impact on development strategy, regulatory pathways, and time to market.
Key Responsibilities
- Lead regulatory due diligence for speciality assets (e.g. Ophthalmology, Neurology, Respiratory)
- Assess clinical, non‑clinical, and CMC data (Modules 1–5) to identify risks and gaps
- Define EU/UK regulatory strategies and recommend pathways to Marketing Authorisation
- Support EMA/MHRA scientific advice and regulatory interactions
- Prepare/review MAAs and manage lifecycle activities (variations, commitments)
- Collaborate cross‑functionally (Clinical, CMC, Commercial, BD) to shape development
Required Background:
- 5–10 years’ experience in regulatory affairs, including regulatory strategy, due diligence, and EMA/UK submissions.
- Excellent understanding of European regulatory requirements to define regulatory strategies in support of development programs for speciality products with focus on EU and UK.
- Significant EU regulatory experience with innovative pharmaceutical formulation developments (Ophthalmology, Neurology, Inhalation products, complex injectables or other innovative product development programs) defining regulatory strategy in support of the development program, leading scientific advice procedures, managing regulatory approval processes and line extension applications through to the granting of the MA and lifecycle maintenance.
- Broad understanding of the requirements to place products on the market within EU.
- Degree or higher degree in pharmacy, life sciences or equivalent.
The following skills are essential for the role:
- Influencing, problem solving, time and project management, flexibility/adaptability, independence, multi-tasking, teamwork, customer focus and effective inter-cultural communication skills.
Senior Manager, Data Management employer: Blackfield Associates
At Blackfield Associates, we pride ourselves on being an exceptional employer, offering a dynamic work environment that fosters collaboration and innovation in the pharmaceutical sector. Our commitment to employee growth is evident through tailored development programmes and opportunities to lead impactful projects in regulatory affairs, particularly within the vibrant EU/UK markets. Join us to be part of a forward-thinking team that values your expertise and encourages meaningful contributions to the advancement of speciality products.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, Data Management
✨Tip Number 1
Network like a pro! Reach out to industry contacts on LinkedIn or at events. We all know that sometimes it’s not just what you know, but who you know that can get you in the door.
✨Tip Number 2
Prepare for interviews by researching the company and its products. We want you to show genuine interest and knowledge about their portfolio, especially in speciality areas like Ophthalmology and Neurology.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with their needs, particularly in regulatory strategy and lifecycle management. We’re talking about making a strong case for why you’re the perfect fit.
✨Tip Number 4
Don’t forget to follow up after interviews! A quick thank-you email can go a long way. It shows your enthusiasm and keeps you fresh in their minds. And remember, check out our website for more opportunities!
We think you need these skills to ace Senior Manager, Data Management
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Senior Regulatory Affairs Manager. Highlight your experience in regulatory strategy and any specific projects related to speciality products like Ophthalmology or Neurology. We want to see how your background aligns with 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 can help us shape development strategies. Be sure to mention your experience with EMA/MHRA interactions, as that’s key for us.
Showcase Your Teamwork Skills:Collaboration is crucial in this role, so don’t forget to highlight your teamwork experiences. Share examples of how you've worked cross-functionally in the past, especially in relation to clinical and commercial teams. We love seeing how you can fit into our culture!
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at Blackfield Associates
✨Know Your Regulatory Stuff
Make sure you brush up on the latest EU and UK regulatory requirements, especially for speciality products. Be ready to discuss how your experience aligns with the role's focus areas like Ophthalmology and Neurology.
✨Showcase Your Strategic Thinking
Prepare examples of how you've defined regulatory strategies in past roles. Highlight specific instances where your decisions impacted development pathways or time to market, as this will resonate well with the interviewers.
✨Collaborate Like a Pro
Since this role involves cross-functional collaboration, think of examples where you've successfully worked with teams from Clinical, CMC, or Commercial. Emphasise your teamwork skills and how they contributed to successful outcomes.
✨Be Ready for Problem-Solving Questions
Expect questions that assess your problem-solving abilities. Prepare scenarios where you identified risks or gaps in regulatory data and how you addressed them. This will showcase your analytical skills and adaptability.
