At a Glance
- Tasks: Lead regulatory activities across EMEA and emerging markets for a global pharmaceutical company.
- Company: Join an international pharmaceutical organisation with a focus on innovation and expansion.
- Benefits: Permanent full-time role with hybrid working options and competitive salary.
- Other info: Collaborative team environment with opportunities for professional growth.
- Why this job: Make a real impact in global health by managing regulatory submissions and product lifecycles.
- Qualifications: Degree in Life Sciences and 5+ years in international regulatory affairs required.
The predicted salary is between 60000 - 80000 € per year.
Blackfield Associates is proud to be partnered exclusively with an international pharmaceutical organisation that is expanding its International & Emerging Markets Regulatory team. We are seeking an experienced Regulatory Affairs Manager to take ownership of regulatory activities across EMEA and emerging markets. This is a hands‑on role for a regulatory professional with proven experience taking approved dossiers and managing local submissions across emerging markets, including direct interaction with Health Authorities.
Key Responsibilities:
- Prepare and submit new Marketing Authorisation Applications (MAAs) supporting international countries within the Emerging markets region
- Support global expansion through the submission of registration dossiers for existing products
- Lead dossier remediation activities, including aligning legacy registrations with current regulatory requirements to enable geographic expansion
- Support lifecycle management of marketed products, including Variations, Renewals, and PSURs
- Liaise closely with local Regulatory Affairs affiliates on regulatory documentation, including labelling, variations, and new registrations
- Provide hands‑on support for country‑specific labelling requirements
- Track registrations using relevant regulatory databases and tracking systems
- Provide regulatory input to cross‑functional teams, including portfolio management, out‑licensing, and launch management
- Proactively contribute to the development and continuous improvement of the Regulatory Affairs function, supporting the successful commercialisation of products across international markets within EMEA
Required Experience & Qualifications:
- Degree‑qualified in a Life Sciences discipline or related field
- Minimum 5 years’ experience supporting international regulatory markets
- Proven experience managing new MAAs, global expansion of existing products, and extensive lifecycle maintenance (essential)
- Experience working closely with international Regulatory Affairs affiliates
- Strong ability to manage multiple priorities and deadlines simultaneously
- Able to work independently while contributing effectively within a collaborative team environment
Additional Information:
- This is a permanent, full‑time position
- Based at the Slough affiliate office, with hybrid working required
- Sponsorship is not available – candidates must have full right to work in the UK
- Flexibility around working hours is required due to international territories
Manager Global Regulatory Affairs in London employer: Blackfield Associates
At Blackfield Associates, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation. Our Slough office provides a supportive environment for Regulatory Affairs professionals, with ample opportunities for personal and professional growth, as well as the chance to make a significant impact in the international pharmaceutical landscape. Join us to be part of a team that values your expertise and encourages continuous improvement in regulatory practices across emerging markets.
StudySmarter Expert Advice🤫
We think this is how you could land Manager Global Regulatory Affairs in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be when it comes to landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of local regulations and recent changes in the industry. We recommend practising common interview questions with a friend to boost your confidence and ensure you shine during the real deal.
✨Tip Number 3
Showcase your hands-on experience! When discussing your past roles, highlight specific examples where you managed submissions or liaised with health authorities. We want to see how you’ve made an impact in your previous positions.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Manager Global Regulatory Affairs in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Regulatory Affairs Manager. Highlight your experience with MAAs and lifecycle management, as these are key for us. Use specific examples that showcase your skills in managing submissions across international markets.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Explain why you're passionate about regulatory affairs and how your background aligns with our needs. Don’t forget to mention your experience with local submissions and liaising with Health Authorities.
Showcase Your Team Spirit:We love collaboration at StudySmarter! In your application, emphasise your ability to work within a team while also managing your own priorities. Share examples of how you've contributed to team success in previous roles.
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 don’t miss any important updates. Plus, it shows 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 your knowledge of regulatory affairs, especially in the EMEA and emerging markets. Familiarise yourself with recent changes in regulations and be ready to discuss how you've managed MAAs and lifecycle maintenance in your previous roles.
✨Showcase Your Hands-On Experience
Prepare specific examples from your past work where you took ownership of regulatory activities. Highlight instances where you interacted with Health Authorities or led dossier remediation activities, as this will demonstrate your hands-on approach and expertise.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges. Think about potential scenarios related to labelling requirements or managing multiple priorities, and prepare your thought process on how you'd tackle these situations effectively.
✨Emphasise Team Collaboration
Since this role involves liaising with local Regulatory Affairs affiliates, be prepared to discuss how you’ve successfully worked within cross-functional teams. Share examples of how your collaborative efforts have contributed to successful product launches or regulatory submissions.
