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.
What You Bring
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.
✨ Why This Role Matters
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