Consultant Regulatory Affairs & PublishingLocation: Hybrid - Madrid or WarsawWe are looking for an experienced Regulatory Affairs professional to join our growing team and play a key role in managing regulatory activities for medicinal products across European markets.This position offers the opportunity to lead complex regulatory projects, contribute to regulatory strategy, and work closely with cross-functional teams and health authorities to support the successful lifecycle management of our product portfolio.What's in it for you?Make a real impact: Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma, biotech and medical devicesGrow within a community of experts: Benefit from knowledge-sharing, mentoring, and exposure to diverse, challenging assignments that broaden your expertise.Build a meaningful career: As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.A fair, competitive package: We offer tailored, transparent compensation aligned with your expertise, preferences, and local market regulations - because your contribution deserves to be valued.What you'll be doing- Lead and manage regulatory submissions, renewals, and post-approval variations for medicinal products across Europe, including National, MRP, DCP, and Centralised Procedures.- Develop and implement regulatory strategies that support business objectives and ensure compliance throughout the product lifecycle.- Serve as the regulatory lead for assigned products and provide strategic regulatory guidance to internal stakeholders.- Assess the regulatory impact of manufacturing,



quality, supply chain, and business changes and recommend optimal regulatory pathways.- Prepare, review, and coordinate regulatory documentation, including Module 1 submissions and eCTD dossiers.- Manage interactions with European and national Health Authorities, including the preparation of responses to regulatory questions and deficiency letters.- Oversee eCTD publishing and electronic submissions through applicable submission platforms.- Ensure compliance and maintenance of product information, including SmPC, PIL, and packaging artwork.- Monitor and interpret evolving regulatory requirements and assess their impact on the company's product portfolio.- Support continuous improvement initiatives within Regulatory Affairs processes and systems.- Mentor and provide guidance to junior team members, sharing expertise and best practices across the organization.What you bring- University degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.- Minimum 6-8 years of Regulatory Affairs experience within the pharmaceutical industry.- Proven experience independently managing regulatory procedures, including variations, renewals,



and marketing authorization applications.- Strong knowledge of EU pharmaceutical legislation and regulatory requirements.- Hands-on experience with National, MRP, DCP, and/or Centralised Procedures.- Demonstrated experience in regulatory strategy development and lifecycle management.- Solid knowledge of CTD/eCTD dossier structure and submission requirements.- Experience with electronic submission platforms such as CESP, EMA Gateway, or equivalent.- Experience communicating directly with regulatory authorities and managing regulatory queries.- Strong project management skills with the ability to manage multiple priorities in a dynamic environment.- Excellent analytical, organizational, and problem-solving skills.- Strong stakeholder management and communication skills.Who you areOur culture is driven by values If this sounds like you, you'll fit right in:- You're resilient and tackle challenges with a positive mindset- You're curious and always up for learning something new- You have a no non-sense approach honest, clear, respectful- You're innovative and bring ideas, not just opinions- And above all, you're serious about your work, but not too serious about yourselfWe support life sciences companies from idea to patient - offering tailored solutions in development, clinical, regulatory, compliance, production, and distribution. With 500+ experts across 8 countries, we help drive innovation in ATMP, biotech, medical devices, diagnostics, digital health, and pharma.We believe in JPEG:Joy. Partnership. Going the Extra Mile. Getting Things Done.You won't just be taking a job - you'll be joining a community where people grow, laugh, build, and contribute to something bigger.#J-18808-Ljbffr

📌 Consultant Regulatory Affairs & Publishing (Madrid)
🏢 QbD Group
📍 Madrid