Regulatory Affairs Manager

Regulatory Affairs Manager

Full-Time 36000 - 60000 £ / year (est.) No home office possible
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G&L Scientific

At a Glance

  • Tasks: Lead regulatory strategies for life-changing medicines and ensure compliance across global markets.
  • Company: G&L, a growing global leader in pharmaceuticals with exciting opportunities.
  • Benefits: Competitive salary, dynamic work environment, and the chance to impact global health.
  • Other info: Opportunities available in Barcelona, Belfast, London, and Mumbai.
  • Why this job: Join us to help bring safe, effective medicines to patients worldwide.
  • Qualifications: Experience in Regulatory Affairs, especially with Biologics or Vaccines, is essential.

The predicted salary is between 36000 - 60000 £ 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
  • Annual reports
  • Evaluate Manufacturing and Quality Changes
  • Review change controls and assess how manufacturing or quality updates impact regulatory filings.
  • Collaborate with quality and manufacturing teams to review key reports such as:
    • Process validation studies
    • Stability studies
    • Analytical method validation
  • Draft and review CMC sections of regulatory documents, including:
    • Variation submissions
    • Responses to health authority questions
    • Technical regulatory documentation
  • Oversee projects within Regulatory Information Management (RIM) systems, ensuring global submissions are tracked, maintained, and compliant.
  • Anticipate and Manage Risk
  • What You Bring
    • 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 employer: G&L Scientific

    G&L is an exceptional employer that fosters a dynamic and collaborative work culture, particularly in our vibrant offices located in Barcelona, Belfast, London, and Mumbai. We are committed to employee growth, offering numerous opportunities for professional development while working on impactful projects that bring life-changing medicines to patients worldwide. Join us to be part of a team that values innovation, regulatory excellence, and the chance to make a meaningful difference in the pharmaceutical industry.
    G&L Scientific

    Contact Detail:

    G&L Scientific Recruiting Team

    StudySmarter Expert Advice 🤫

    We think this is how you could land Regulatory Affairs Manager

    ✨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 challenges and think about how your experience can help them overcome these hurdles. Show them you’re not just another candidate!

    ✨Tip Number 3

    Practice your pitch! Be ready to explain your experience in Regulatory Affairs clearly and confidently. Highlight your problem-solving skills and how you've successfully navigated complex regulatory landscapes in the past.

    ✨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 brand.

    We think you need these skills to ace Regulatory Affairs Manager

    Regulatory Affairs
    CMC Regulatory Documentation
    Post-Approval Regulatory Strategies
    Change Control Evaluation
    Regulatory Classification
    Submission Requirements
    Collaboration with Cross-Functional Teams
    Technical Regulatory Documentation
    Risk Management
    Attention to Detail
    Problem-Solving Skills
    Project Management
    Knowledge of Stability Studies
    Experience with Biological Products or Vaccines
    Fluency in English

    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 skills align with what we're looking for!

    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 variations and renewals. This will show that you’re not just familiar with the theory but have practical insights to bring to the table.

    ✨Showcase Your Problem-Solving Skills

    Prepare to share instances where you've tackled complex regulatory challenges. Think about how you identified potential issues and what strategies you implemented to keep projects on track. This will highlight your ability to think critically and act decisively in high-pressure situations.

    ✨Collaboration is Key

    Since this role involves working closely with various teams, be ready to discuss your experience collaborating across functions like manufacturing, quality control, and global regulatory teams. Highlight any successful projects where teamwork was essential to achieving compliance and meeting deadlines.

    ✨Communicate Clearly

    Practice translating complex scientific data into clear regulatory narratives. During the interview, aim to demonstrate your ability to draft and review technical documents succinctly. This skill is crucial for the role, so showing that you can communicate effectively will set you apart.

    Regulatory Affairs Manager
    G&L Scientific
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