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 flexibility around hours.
- 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 - 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 Global Regulatory Affairs in Slough employer: Blackfield Associates
At Blackfield Associates, we pride ourselves on fostering a dynamic and inclusive work environment that empowers our employees to thrive. As a Regulatory Affairs Manager in our Slough office, you will benefit from a collaborative culture that values innovation and professional growth, alongside flexible working arrangements that support a healthy work-life balance. Join us to make a meaningful impact in the pharmaceutical industry while advancing your career in a supportive and forward-thinking organisation.
StudySmarter Expert Advice🤫
We think this is how you could land Manager Global Regulatory Affairs in Slough
✨Network Like a Pro
Get out there and connect with people in the industry! Attend conferences, webinars, or local meetups. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Ace the Informational Interview
Reach out to professionals already working in regulatory affairs. Ask for a quick chat to learn about their experiences. This not only helps you gather insights but also shows your genuine interest in the field.
✨Showcase Your Skills
When you get the chance to meet potential employers, be ready to talk about your hands-on experience with MAAs and lifecycle management. Use specific examples to demonstrate how you've successfully navigated regulatory challenges.
✨Apply Through Our Website
Don't forget to check out our website for the latest job openings! Applying directly through us gives you a better chance of being noticed, and we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Manager Global Regulatory Affairs 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 showcase your skills in managing submissions and working with Health Authorities.
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 in international markets and your ability to manage multiple priorities.
Showcase Your Team Spirit:We love collaboration at StudySmarter! In your application, highlight instances where you’ve worked closely with cross-functional teams or local affiliates. This shows us you can thrive in a team environment while also taking ownership of your responsibilities.
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 gives you a chance to explore more about our company culture and values!
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 taking ownership, so be prepared to share specific examples of how you've successfully handled submissions and liaised with Health Authorities. Highlight any direct interactions you've had and how they contributed to successful outcomes.
✨Demonstrate Your Team Spirit
While this position requires independence, collaboration is key. Be ready to talk about how you've worked with cross-functional teams in the past. Share instances where your regulatory input made a difference in product launches or portfolio management.
✨Stay Organised and Prioritise
With multiple priorities and deadlines, it's crucial to show that you can manage your time effectively. Discuss your strategies for tracking registrations and managing various regulatory documentation. This will demonstrate your ability to thrive in a fast-paced environment.
