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, Contracts 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 market. 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, Contracts 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 help you land that Senior Regulatory Affairs Manager role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU/UK regulatory strategies. We recommend practising common interview questions and scenarios related to regulatory affairs to show you’re the perfect fit for the job.
✨Tip Number 3
Don’t forget to showcase your cross-functional collaboration skills! During interviews, share examples of how you’ve worked with Clinical, CMC, and Commercial teams. We want to see how you can shape development strategies together.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Senior Manager, Contracts Management
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. We want to see how your background aligns with what we're looking for!
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. Be sure to mention your experience with EU/UK submissions and any relevant therapeutic areas.
Showcase Your Achievements:When detailing your experience, focus on your achievements rather than just responsibilities. Did you lead a successful submission? Did you reduce time to market for a product? We love to see quantifiable results that demonstrate your impact!
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 specific examples from your experience that demonstrate your understanding of regulatory strategies and how they impact development programmes.
✨Showcase Your Cross-Functional Collaboration
This role involves working closely with various teams like Clinical, CMC, and Commercial. Prepare to share instances where you've successfully collaborated across functions to shape development strategies or resolve issues. Highlight your teamwork skills and how they contributed to project success.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving abilities in real-world scenarios. Think about challenges you've faced in regulatory affairs, particularly around due diligence or managing lifecycle activities, and be ready to explain how you navigated those situations.
✨Demonstrate Your Influencing Skills
As a Senior Manager, you'll need to influence decisions and strategies. Prepare examples of how you've effectively influenced stakeholders or led discussions that resulted in positive outcomes. This will show your ability to drive change and support the organisation's goals.
