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Regulatory Affairs Manager
hace 14 minutos
Shape the future of medicines with a global consultancy that values expertise, energy, and impact.G&L Scientific is a global regulatory consultancy with offices across three continents. We partner with some of the world's largest pharmaceutical and biotech companies, while also supporting innovative smaller organisations that need true end-to-end regulatory expertise. What unites all our clients is their trust in us to deliver smart, pragmatic, and high-quality regulatory solutions.Our Spanish team is well established and highly respected, supporting a diverse and loyal client base. From early development through to post-approval activities, we adapt quickly and effectively, ensuring our stakeholders have access to expert advice, strategic insight, and hands-on regulatory support when it matters most. No two projects are the same, and no challenge is too complex. Our consultants thrive on finding solutions, staying ahead of regulation, and ultimately helping ensure medicines reach patients safely and efficiently.The OpportunityWe are now looking for an experienced Regulatory Affairs Manager to join our growing team in Barcelona. This is an exciting opportunity for a confident regulatory professional who enjoys client interaction, values quality, and is motivated by variety and continuous learning.You will work across multiple projects and clients, acting as a trusted regulatory advisor, managing documentation, guiding strategy, and ensuring compliance across the product lifecycle. If you enjoy autonomy, responsibility, and working in a dynamic consultancy environment, this role will suit you perfectly.Your Responsibilities· Define and execute regulatory strategies to support product registrations in line with applicable regulations· Prepare, develop, and review CMC documentation (Module 3), quality summaries, and safety and efficacy documentation· Manage safety, efficacy, and CMC variations, including classification, documentation preparation and submission .· Support R&D, manufacturing, quality control, and quality assurance teams with regulatory input· Submit regulatory documentation to authorities ensuring compliance with the regulatory standards.· Act as the primary regulatory point of contact for assigned client accounts, ensuring high-quality communication, proactive issue identification and timely delivery of milestones.· Ensure ongoing product compliance throughout the lifecycle by monitoring regulatory changes and assessing impact· Maintain strong awareness of current and upcoming EU regulatory requirements· Support Senior Project Managers with day-to-day project activities· Mentor junior team members, providing training and internal guidance to strengthen regulatory capabilities within the team.· Manage authorisations under national and EU procedures (MRP, DCP, and Centralised)· Ensure all project work meets current regulatory guidance and internal quality standards· Write and review Modules 3, 4, and 5· Contribute to knowledge sharing and continuous improvement within the teamEducation· Bachelor's or Master's degree in a health or life science disciplineExperience· 7+ years of experience in Regulatory Affairs· At least 3 years' experience within a pharmaceutical company· Hands-on experience with European e-submission portals· Practical experience working with multiple National Competent Authorities· Experience with small and large molecules across different therapy areas and dosage forms· Experience in writing and reviewing Module 3, Module 4 and Module 5.· Experience with biological products is a strong advantage.Skills & Competencies· Strong organisational and communication skills, with the ability to manage multiple projects· Ability to lead client-facing technical discussions and influence regulatory strategy across R&D, QA, QC and manufacturing teams.· Confident, proactive, and client-focused approach· Collaborative mindset and enthusiasm for continuous learning· Excellent working knowledge of MS Office· Fluent written and spoken English and Spanish· High attention to detail, strong analytical skills, and ability to summarise complex information· Flexible, adaptable, and solutions-oriented· Expert ability to interpret regulatory requirements and define compliant strategiesWhy Join G&L Scientific?· Competitive salary aligned with your experience· Comprehensive benefits package (medical insurance, disability insurance, pension plan, flexible remuneration)· Flexible working hours· Hybrid working model (2 days per week in our Barcelona office)· Exposure to a wide variety of projects, clients, and regulatory challenges· A collaborative, international environment where your expertise is valued and your career can growIf you are a driven regulatory professional looking to make an impact in a fast-paced, consultancy environment, we would love to hear from you.
