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- Tasks: Lead regulatory strategies for life-changing medicines and ensure compliance across global markets.
- Company: Join a growing global team at G&L, passionate about science and regulatory excellence.
- Benefits: Exciting career opportunities in vibrant locations like Barcelona, Belfast, London, and Mumbai.
- Why this job: Make a real impact by ensuring safe medicines reach patients worldwide.
- Qualifications: Experience in Regulatory Affairs, especially with Biologics or Vaccines, is essential.
- Other info: Collaborative environment with a focus on innovation and problem-solving.
The predicted salary is between 50000 - 70000 £ per year.
G&L have multiple positions available for Regulatory Affairs Manager. We are growing our teams on a global basis; there has never been a more exciting time to join us! Please note that we have vacancies in Barcelona, Belfast, London and Mumbai. If you have the experience we require and can work in one of our offices, we want to hear from you!
Do you want to help bring life-changing medicines to the world? Are you passionate about science, strategy, and regulatory excellence? As a CMC Regulatory Manager, you’ll play a key role in ensuring that high-quality medicines continue to reach patients safely and efficiently across global markets. You’ll sit at the intersection of science, manufacturing, and regulatory strategy, guiding post-approval activities and ensuring that every change to our products meets global regulatory standards.
If you enjoy solving complex problems, working across teams, and translating technical data into clear regulatory strategies, this role is for you.
What You’ll Be Doing- Lead Post-Approval Regulatory Strategies
- Develop and implement regulatory strategies for post-approval CMC activities, including: Variations, Renewals, Market expansions, Annual reports. Your work ensures our products continue to meet global regulatory expectations throughout their lifecycle.
- Evaluate Manufacturing and Quality Changes
- Review change controls and assess how manufacturing or quality updates impact regulatory filings. You’ll determine: Regulatory classification of changes, Submission requirements, Global regulatory impact.
- Review Critical Scientific Data
- Collaborate with quality and manufacturing teams to review key reports such as: Process validation studies, Stability studies, Analytical method validation. You’ll ensure all data supports regulatory submissions and meets compliance standards.
- Collaborate Across Teams
- Work closely with colleagues across: Manufacturing, Supply Chain, Quality Control, Quality Assurance, Global Regulatory teams. Your coordination keeps submissions accurate, complete, and on schedule.
- Shape Regulatory Submissions
- Draft and review CMC sections of regulatory documents, including: Variation submissions, Responses to health authority questions, Technical regulatory documentation. Your expertise helps transform complex scientific information into clear regulatory narratives.
- Manage Regulatory Systems
- Oversee projects within Regulatory Information Management (RIM) systems, ensuring global submissions are tracked, maintained, and compliant.
- Anticipate and Manage Risk
- Identify potential regulatory challenges early and implement strategies to keep projects on track.
- Experience
- Experience in Regulatory Affairs within the pharmaceutical industry.
- Strong background in CMC or technical regulatory documentation.
- Experience preparing CMC sections of regulatory submissions or variations.
- Experience in validation, quality assurance, or pharmaceutical production is highly valued.
- Technical Knowledge
- Strong understanding of CMC and post-approval regulatory requirements.
- Knowledge of: Stability studies, Process validation, Analytical method validation, Comparability studies.
- Experience working with Biological products or vaccines is a mandatory requirement for this role.
- Skills That Make You Shine
- Exceptional attention to detail.
- Strong problem-solving ability.
- Excellent project management skills.
- Ability to collaborate with cross-functional global teams.
- Languages
- Fluency in English (written and spoken).
- Additional language (French, Italian, or German) is a plus.
Your work ensures that safe, effective medicines continue to reach patients around the world — even as products evolve and improve. In short: you help science move forward, compliantly. Please only apply for this role if you have demonstrable experience working with Biologics or Vaccines.
Regulatory Affairs Manager in Slough employer: G&L Scientific
Contact Detail:
G&L Scientific Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager in Slough
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their regulatory processes and be ready to discuss how your experience aligns with their needs. Show them you’re not just another candidate!
✨Tip Number 3
Practice your pitch! Be clear about your experience in Regulatory Affairs and how it relates to the role. Highlight your problem-solving skills and ability to collaborate across teams — that’s what they want to hear!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive and engaged with our company.
We think you need these skills to ace Regulatory Affairs Manager in Slough
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your experience in CMC and any relevant projects you've worked on. We want to see how your background aligns with our needs!
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 you can contribute to our mission of bringing life-changing medicines to the world. Keep it engaging and personal!
Showcase Your Problem-Solving Skills: In your application, don’t forget to mention specific examples where you've tackled complex regulatory challenges. We love seeing how you approach problems and find solutions, especially in a cross-functional team setting.
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 you’re keen on joining our team!
How to prepare for a job interview at G&L Scientific
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of CMC and post-approval regulatory requirements. Be ready to discuss specific examples from your experience, especially related to biologics or vaccines, as this will show that you understand the complexities of the role.
✨Showcase Your Problem-Solving Skills
Prepare to share instances where you've tackled complex regulatory challenges. Think about how you evaluated manufacturing changes or collaborated with cross-functional teams to ensure compliance. This will highlight your ability to navigate tricky situations.
✨Be Ready to Discuss Team Collaboration
Since this role involves working closely with various teams, come prepared with examples of successful collaborations. Talk about how you’ve coordinated with manufacturing, quality control, and global regulatory teams to keep submissions accurate and on schedule.
✨Practice Your Technical Communication
You’ll need to translate complex scientific data into clear regulatory narratives. Prepare to explain how you’ve drafted CMC sections of regulatory documents in the past. Practising this will help you convey your expertise effectively during the interview.