Regulatory Affairs Specialist
hace 2 días
Join to apply for the Regulatory Affairs Specialist role at ESTEVE . Overview Manage the regulatory lifecycle of US FDA‑approved products, ensuring ongoing compliance and supporting regulatory activities for new product development projects. Work closely with cross‑functional teams including Global Regulatory, clinical, pharmacovigilance, and external partners to ensure timely and accurate regulatory submissions and provide strategic input throughout the product lifecycle. Key Responsibilities Prepare, review, and submit FDA documentation, including supplements, annual reports, and amendments. Monitor and interpret changes in FDA regulations and assess impact on existing products. Maintain regulatory compliance for marketed products, including labeling and post‑market surveillance. Collaborate with internal and external stakeholders on transversal projects, providing regulatory recommendations. Support regulatory activities for product development projects, developing regulatory strategies and timelines. Provide general departmental support, including meeting preparations, dossier archiving, RIMS, etc. Qualifications Required Studies: Bachelor’s degree in Life Science, Pharmaceutical Sciences, Biology, or Chemistry. Professional Experience: Minimum 3–5 years in Regulatory Affairs within a pharmaceutical company or CRO. Specialized Knowledge: Strong understanding of US FDA regulatory pathways and guidance documents. Proven experience with FDA submissions. Experience supporting development projects and working with cross‑functional teams. Excellent interpersonal communication skills (written and verbal). Proficiency with PowerPoint, Excel, and Microsoft 365. Languages: Fluent English (required). Spanish (required). Other languages are a plus. Additional Information: Referrals increase your chances of interviewing at ESTEVE by 2x. Seniority level: Mid‑Senior level Employment type: Full‑time Job function: Science Industries: Pharmaceutical Manufacturing #J-18808-Ljbffr
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Regulatory Affairs Associate
hace 5 días
Barcelona, Barcelona, España Inter Regulatory A tiempo completoRegulatory Affairs Associate (Medicines)Location:Barcelona, Spain (Hybrid – Barcelona Health Hub)Company:Inter RegulatoryEmployment Type:Full-timeAbout the roleInter Regulatory is expanding its European Regulatory Affairs team and is seeking aRegulatory Affairs Associate (Medicines)to join our consultancy based inBarcelona, primarily working from...
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Regulatory Affairs Associate
hace 2 días
Barcelona, España Inter Regulatory A tiempo completoRegulatory Affairs Associate (Medicines) Company: Inter RegulatoryEmployment Type: Full-timeAbout the role Inter Regulatory is expanding its European Regulatory Affairs team and is seeking a Regulatory Affairs Associate (Medicines) to join our consultancy based in Barcelona , primarily working from the Barcelona Health Hub .This role is suited to a...
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Regulatory Affairs Associate
hace 2 días
Barcelona, España Inter Regulatory A tiempo completoA growing regulatory consultancy in Barcelona is seeking a Regulatory Affairs Associate with 3-5 years of experience in pharmaceutical Regulatory Affairs. The role involves authoring and managing regulatory dossiers, handling CMC documentation, and supporting US regulatory applications. Candidates should have a scientific degree and be fluent in English and...
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Regulatory Affairs Specialist
hace 2 días
Barcelona, Barcelona, España ESTEVE A tiempo completoJob description:1. FUNCTIONAL CONTENTMain RoleThe Regulatory Affairs Specialist will be responsible for managing the regulatory lifecycle of US FDA-approved products, ensuring ongoing compliance and supporting regulatory activities for the ongoing new product development projects.This role requires close collaboration with cross-functional teams including...
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Global Regulatory Affairs Specialist – Nutraceuticals
hace 1 semana
Barcelona, España Solo Talento | RH Soluciones A tiempo completoUna compañía internacional del sector nutracéutico busca un Regulatory Affairs Specialist para su oficina en Barcelona. Este puesto se centra en garantizar el cumplimiento normativo global, apoyando a las operaciones comerciales y de I+D. El candidato ideal debe tener al menos 4 años de experiencia en Regulatory Affairs en nutracéuticos y un sólido...
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REGULATORY AFFAIRS SPECIALIST
hace 1 semana
Barcelona, España Solo Talento | RH Soluciones A tiempo completoCompañía internacional del sector de nutracéuticos y suplementos dietéticos busca incorporar un Regulatory Affairs Specialist para su sede en Barcelona, con foco en mercados internacionales.Este puesto es clave para garantizar el cumplimiento normativo global, dar soporte a las operaciones comerciales y de I+D, y minimizar riesgos regulatorios en todos...
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REGULATORY AFFAIRS SPECIALIST
hace 3 días
barcelona, España Solo Talento | RH Soluciones A tiempo completoCompañía internacional del sector de nutracéuticos y suplementos dietéticos busca incorporar un Regulatory Affairs Specialist para su sede en Barcelona, con foco en mercados internacionales. Este puesto es clave para garantizar el cumplimiento normativo global, dar soporte a las operaciones comerciales y de I+D, y minimizar riesgos regulatorios en todos...
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MedTech Quality
hace 2 días
Barcelona, España Ersilia A tiempo completoA medical technology company in Barcelona is looking for a Quality & Regulatory Affairs Specialist to enhance quality and regulatory processes. This role involves preparing regulatory submissions, conducting audits, and collaborating on compliance initiatives. Candidates should have a Bachelor’s degree in a relevant field and 2 years of experience in the...
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barcelona, España dsm-firmenich A tiempo completoRegulatory Affairs Documentation Specialist, Flavorings Industry Join to apply for the Regulatory Affairs Documentation Specialist, Flavorings Industry role at dsm-firmenich Job title – Regulatory Affairs Documentation Specialist, Flavorings Industry Location – Barcelona, Spain Do you enjoy being surrounded by regulatory related information and...
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Regulatory Affairs Specialist
hace 1 día
barcelona, España Grouper Technology A tiempo completoRegulatory Affairs Specialist (Full-time, Permanent) Prinova is a leading global supplier of ingredients and premix manufacturing solutions for the food, beverage and nutrition industries. Prinova holds strategic stocks in 35+ centres around the world to ensure continuity of supply and has liquid and dry premix manufacturing facilities in the UK, China and...
