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 the development of cutting-edge therapies in a vital industry.
- 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 / Manager, Regulatory Affairs employer: Blackfield Associates
Join a dynamic and innovative pharmaceutical organisation that prioritises employee development and collaboration. As a Senior Regulatory Affairs Manager, you will be at the forefront of shaping regulatory strategies for cutting-edge speciality products, all while enjoying a supportive work culture that values flexibility and teamwork. With ample opportunities for professional growth and a commitment to making a meaningful impact in healthcare, this role offers a rewarding career path in a thriving environment.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager / Manager, Regulatory Affairs
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field, especially those who have experience with speciality products. Attend industry events or webinars to meet potential employers and get your name out there.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU/UK regulatory strategies. Be ready to discuss how you've tackled challenges in previous roles, particularly around late-stage assets and in-licensing opportunities.
✨Tip Number 3
Showcase your cross-functional collaboration skills! Be prepared to share examples of how you've worked with clinical, CMC, and commercial teams to shape development strategies. This will highlight your ability to influence and problem-solve effectively.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of opportunities that might just be the perfect fit for you. Plus, it’s a great way to ensure your application gets seen by the right people.
We think you need these skills to ace Senior Manager / Manager, Regulatory Affairs
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:Since collaboration is crucial in this role, make sure to include examples of how you've worked cross-functionally in the past. We love seeing candidates who can effectively communicate and work with different teams 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!
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 the role involves cross-functional collaboration, think of examples where you've worked effectively with teams from Clinical, CMC, or Commercial. Emphasise your teamwork skills and how they contributed to successful outcomes.
✨Be Ready for Problem-Solving Scenarios
Expect questions that test your problem-solving abilities. Prepare to discuss challenges you've faced in regulatory affairs and how you navigated them, particularly in relation to managing lifecycle activities and regulatory approvals.
