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 growth.
- Benefits: Competitive salary, career advancement opportunities, and a collaborative work environment.
- Other info: Join a team that values innovation and offers excellent professional development.
- 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 strong knowledge 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, Regulatory Compliance employer: Blackfield Associates
Join a dynamic and innovative pharmaceutical organisation that prioritises employee growth and development in the heart of Europe. As a Senior Manager in Regulatory Compliance, you will be part of a collaborative work culture that values cross-functional teamwork and offers unique opportunities to influence the regulatory landscape for speciality products. With a commitment to excellence and a focus on meaningful contributions, this role provides a rewarding environment for professionals looking to make a significant impact in the industry.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, Regulatory Compliance
✨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 be able to discuss how your experience aligns with their regulatory strategies, especially in speciality areas like Ophthalmology and Neurology.
✨Tip Number 3
Showcase your problem-solving skills during interviews. Think of examples where you’ve navigated complex regulatory challenges. We love hearing about how you’ve influenced outcomes in previous roles!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we’re always looking for passionate individuals who can contribute to our mission in regulatory affairs.
We think you need these skills to ace Senior Manager, Regulatory Compliance
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Regulatory Affairs Manager role. 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 navigate the complexities of EU/UK regulations. Be sure to mention any relevant achievements that demonstrate your expertise.
Showcase Your Cross-Functional Experience:Since collaboration is key in this role, make sure to highlight any experience you've had working with different teams, like Clinical or Commercial. We love seeing candidates who can work well across functions and bring people together to achieve common goals.
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 us 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 times when you've worked with Clinical, CMC, or Commercial teams. Be ready to share how you navigated challenges and contributed to successful outcomes.
✨Demonstrate Problem-Solving Skills
Regulatory affairs can be tricky, so come prepared with examples of how you've identified risks and gaps in data. Discuss your approach to problem-solving and how it led to effective regulatory submissions.
