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- Tasks: Lead regulatory activities for international markets and support product expansions.
- Company: Join a dynamic pharmaceutical company focused on global growth.
- Benefits: Permanent role with hybrid working and opportunities for career advancement.
- Why this job: Make a significant impact in global regulatory affairs and shape the future of healthcare.
- Qualifications: Degree in life sciences and 5+ years in international regulatory experience required.
- Other info: Collaborative team environment with a focus on strategic development.
The predicted salary is between 48000 - 72000 £ per year.
Blackfield Associates are proudly partnered with an international pharmaceutical client on an exclusive basis, who are looking to establish a new team for their international and emerging markets division. We’re looking for an experienced Regulatory Manager to execute activities across international markets and EMEA. This includes submission and maintenance of new products, both generic and speciality, as well as supporting the global expansion of existing products.
As Regulatory Affairs Manager, you will:
- Preparation and submission of new marketing authorisation applications, supporting international countries within the EMEA region
- Preparation and submission of registrations for existing products as part of global expansion activities
- Lead dossier remediation activities, such as aligning older registrations with current regulatory requirements in support of geographic expansion
- Support lifecycle management activities for marketed products, including Variations, Renewals and PSURs
- Liaise with local Regulatory Affairs staff on regulatory documentation, including labelling, variations, and new registrations
- Support local Regulatory Affairs teams with countries-specific labelling activities
- Track registrations using relevant regulatory databases and tracking systems
- Maintain regulatory archives, including dossiers, documents, and media
- Provide regulatory support to cross‑functional teams (portfolio management, out‑licensing, launch management)
- Proactively contribute to the strategic development of the Regulatory Affairs function and support the successful commercial development of international markets within the EMEA region
To be considered for the role of Regulatory Affairs Manager, you will have:
- Educated to degree level in relevant life sciences studies
- Minimum 5 years’ experience supporting international markets
- Previous experience managing New MAA’s, Global expansion of existing products and extensive lifecycle maintenance is essential
- Experience working closely with international Regulatory Affairs affiliates
- Strong ability to manage deadlines and priorities multiple projects simultaneously
- Ability to work independently and collaboratively within a team environment
This is a permanent, full-time role. Located at the affiliate office, you will need to be able to attend the Slough office on a hybrid basis. Unable to sponsor, candidates must have full right to work in the UK and flexibility around working hours due to territories.
Senior Manager Global Regulatory Affairs employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager Global Regulatory Affairs
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those in regulatory affairs. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of international regulations and recent changes in the EMEA region. We want you to shine when discussing your experience with MAAs and lifecycle management!
✨Tip Number 3
Showcase your project management skills! Be ready to discuss how you've juggled multiple projects and met tight deadlines in your previous roles. This will demonstrate your ability to thrive in a fast-paced environment.
✨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 Senior Manager Global Regulatory Affairs
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 marketing authorisation applications and global expansion activities, as these are key for us. Use specific examples that showcase your skills in managing deadlines and working with international teams.
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 relevant experience in regulatory affairs and how you can contribute to our strategic development. Keep it concise but impactful!
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Whether it’s successful submissions or improved processes, we want to see how you've made a difference in your previous roles. Numbers and outcomes speak volumes!
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 out on 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 the latest regulations and guidelines relevant to international markets, especially within the EMEA region. Familiarise yourself with the specifics of marketing authorisation applications and lifecycle management activities, as these will likely come up in your interview.
✨Showcase Your Experience
Prepare to discuss your past experiences managing new MAAs and global expansions. Have specific examples ready that highlight your ability to handle multiple projects and meet deadlines. This will demonstrate your capability to contribute effectively to their team.
✨Understand the Company’s Vision
Research the pharmaceutical client and understand their products and market strategies. Being able to articulate how your skills align with their goals will show that you’re genuinely interested in the role and can contribute to their success.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s regulatory strategies and challenges they face in international markets. This not only shows your interest but also your proactive approach to understanding the role and its impact on the organisation.
