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 DoingLead Post-Approval Regulatory StrategiesDevelop and implement regulatory strategies for post-approval CMC activities, including:
VariationsRenewalsMarket expansionsAnnual reports Your work ensures our products continue to meet global regulatory expectations throughout their lifecycle.Evaluate Manufacturing and Quality ChangesReview change controls and assess how manufacturing or quality updates impact regulatory filings.You'll determine:
Regulatory classification of changesSubmission requirementsGlobal regulatory impact Review Critical Scientific DataCollaborate with quality and manufacturing teams to review key reports such as:
Process validation studiesStability studiesAnalytical method validation You'll ensure all data supports regulatory submissions and meets compliance standards.Collaborate Across TeamsWork closely with colleagues across:
ManufacturingSupply ChainQuality ControlQuality AssuranceGlobal Regulatory teams Your coordination keeps submissions accurate, complete, and on schedule.Shape Regulatory SubmissionsDraft and review CMC sections of regulatory documents, including:
Variation submissionsResponses to health authority questionsTechnical regulatory documentation Your expertise helps transform complex scientific information into clear regulatory narratives.Manage Regulatory SystemsOversee projects within Regulatory Information Management (RIM) systems, ensuring global submissions are tracked, maintained, and compliant.Anticipate and Manage RiskIdentify potential regulatory challenges early and implement strategies to keep projects on track.What You BringExperience
Experience in Regulatory Affairs within the pharmaceutical industryStrong background in CMC or technical regulatory documentationExperience preparing CMC sections of regulatory submissions or variationsExperience in validation, quality assurance, or pharmaceutical production is highly valued Technical Knowledge
Strong understanding of CMC and post-approval regulatory requirementsKnowledge of:Stability studiesProcess validationAnalytical method validationComparability studiesExperience working with Biological products or vaccines is a mandatory requirement for this role. Skills That Make You Shine
Exceptional attention to detailStrong problem-solving abilityExcellent project management skillsAbility 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 MattersYour 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