At a Glance
- Tasks: Manage regulatory activities across EMEA and emerging markets for a leading pharmaceutical company.
- Company: Join an international pharmaceutical organisation with a focus on innovation and growth.
- Benefits: Permanent, full-time role with hybrid working and flexible hours.
- Other info: Collaborative team environment with opportunities for professional development.
- Why this job: Make a real impact in global health by supporting product registrations and expansions.
- Qualifications: Degree in Life Sciences and 5+ years in international regulatory affairs required.
The predicted salary is between 60000 - 75000 € 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 Clinical Regulatory Affairs (m/w/d) in Slough 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 where employees can thrive, with ample opportunities for professional growth and development in the fast-paced pharmaceutical sector. Join us to make a meaningful impact in international regulatory affairs while enjoying the benefits of hybrid working and a flexible schedule.
StudySmarter Expert Advice🤫
We think this is how you could land Manager Clinical Regulatory Affairs (m/w/d) in Slough
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those in regulatory affairs. 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 international regulatory requirements. Be ready to discuss your experience with MAAs and lifecycle management, as these are key areas for the role.
✨Tip Number 3
Showcase your hands-on experience! When you get the chance to speak with hiring managers, highlight specific examples of how you've managed submissions and liaised with health authorities in emerging markets.
✨Tip Number 4
Don't forget to apply through our website! We have a range of opportunities that could be perfect for you, and applying directly can sometimes give you an edge over other candidates.
We think you need these skills to ace Manager Clinical Regulatory Affairs (m/w/d) in Slough
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 show how you've successfully navigated regulatory challenges in international markets.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for our team. Mention your hands-on experience with submissions and your ability to liaise with Health Authorities. Keep it engaging and personal – we want to get to know you!
Showcase Your Achievements:Don't just list your responsibilities; showcase your achievements! Quantify your successes where possible, like the number of successful submissions or improvements in processes. This will help us see the impact you've made in your previous roles.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep track of 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
This role is all about being hands-on, so prepare examples that highlight your direct involvement with submissions and interactions with Health Authorities. Be specific about the challenges you faced and how you overcame them.
✨Demonstrate Team Collaboration
Since this position requires working closely with local Regulatory Affairs affiliates, think of instances where you successfully collaborated with cross-functional teams. Share how you contributed to projects and supported others in achieving regulatory goals.
✨Be Ready for Scenario Questions
Expect scenario-based questions that test your problem-solving skills in real-world regulatory situations. Prepare by thinking through potential challenges you might face in this role and how you would address them effectively.
