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 regulations.
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, Resilience 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, Resilience
✨Tip Number 1
Network like a pro! Reach out to industry professionals on LinkedIn or attend relevant events. We can’t stress enough how personal connections can open doors that applications alone can’t.
✨Tip Number 2
Prepare for interviews by researching the company and its products. We recommend practising common interview questions and tailoring your answers to highlight your experience in regulatory affairs, especially in speciality products.
✨Tip Number 3
Showcase your expertise! Bring along examples of your past work, especially any successful regulatory strategies you’ve implemented. We love seeing candidates who can demonstrate their impact in previous roles.
✨Tip Number 4
Don’t forget to follow up after interviews! A quick thank-you email can keep you top of mind. And remember, apply through our website for the best chance at landing that dream job!
We think you need these skills to ace Senior/Manager - Data Management, Resilience
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role. Highlight your experience in regulatory affairs, especially with EU/UK submissions and speciality products. We want to see how your background aligns with the key responsibilities listed in the job description.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Mention specific experiences that relate to leading regulatory strategies and managing lifecycle activities. We love a good story!
Showcase Your Skills:Don’t forget to highlight those essential skills like problem-solving and teamwork. Use examples from your past roles to demonstrate how you've successfully influenced decisions or managed projects. We’re all about collaboration here at StudySmarter!
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. Plus, it’s super easy!
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 on Ophthalmology, Neurology, and Respiratory products.
✨Showcase Your Strategic Thinking
Prepare examples of how you've defined regulatory strategies in past roles. Highlight your ability to assess clinical and non-clinical data, and be ready to discuss how you’ve identified risks and gaps in previous projects.
✨Collaboration is Key
This role involves working cross-functionally, so think of instances where you've successfully collaborated with Clinical, CMC, or Commercial teams. Be prepared to share how you’ve influenced decisions and shaped development strategies.
✨Be Ready for Scenario Questions
Expect questions that test your problem-solving skills and adaptability. Think about challenges you've faced in regulatory affairs and how you navigated them, particularly in high-stakes situations involving late-stage assets.
