Regulatory Affairs Expert

hace 1 día

Barcelona, España Project Delivery Partners A tiempo completo

Position Title: CMC RA Expert Location: Barcelona Type of Contract: Full-Time / On site PharmEng Technology, an Efor Group of Companies, is a leading pharmaceutical and biopharmaceutical consulting company committed to providing innovative solutions to the challenges facing our industries. We pride ourselves on our dedication to quality, safety, and excellence in everything we do. As we continue to grow, we are looking for a highly qualified and motivated Senior CMC RA Expert to join our team. Position Summary The Regulatory Affairs CMC Specialist ensures compliance of Chemistry, Manufacturing, and Controls (CMC) documentation across affiliated companies and Contract Manufacturing Organizations (CMOs). This role safeguards product lifecycle integrity by aligning regulatory dossiers with actual manufacturing and quality practices, preventing discrepancies that could impact approvals, renewals, or variations. This position is on-site and requires fluent Spanish and English Key Responsibilities Prepare core documentation packages for affiliated companies to submit CMC variations and dossier renewals. Assess and manage the impact of CMC changes on Regulatory Affairs compliance. Ensure alignment between dossier licensors and CMOs to prevent regulatory discrepancies. Monitor and harmonize specifications, analytical methods, and dossier sections across multiple markets. Collaborate with Quality Assurance, Production, and Regulatory Affairs teams to maintain dossier accuracy. Act as a liaison between licensors, CMOs, and internal departments to support compliance and product availability. Qualifications Bachelors or Masters degree in Pharmacy, Chemistry, Biotechnology, or related field. + 10 years of experience in Regulatory Affairs within the pharmaceutical industry, with a focus on CMC. Strong knowledge of GMP, ICH guidelines, and global regulatory frameworks. Excellent organizational, documentation, and analytical skills. Strong communication and stakeholder management abilities. Fluent Spanish and English are mandatory. What We Offer Competitive compensation based on experience and project scope. Exposure to international pharmaceutical operations and regulatory environments. Opportunity to lead high-impact injectable validation programs. Flexible work arrangements and travel support. Collaborative and technically driven work culture. Join us: If you are a dedicated and highly motivated individual with a passion for ensuring the highest standards of EHS in the Pharmaceutical Industry, we encourage you to apply. PharmEng / Efor offers a dynamic and inclusive work environment, competitive compensation, and opportunities for professional growth. Be part of our team and contribute to the success of our industry-leading solutions. PharmEng / Efor is an equal opportunity employer and welcomes applicants from all backgrounds. Thank you for your consideration and application We review all resumes and submissions, however, due to the high volume of applications we receive, only approved candidates will be contacted.

  • Regulatory Affairs Expert

    hace 3 días

    Barcelona, Barcelona, España Project Delivery Partners A tiempo completo

    Regulatory Affairs ExpertJob Description:Position Title: CMC RA ExpertLocation: BarcelonaType of Contract: Full-Time / On sitePharmEng Technology, an Efor Group of Companies, is a leading pharmaceutical and biopharmaceutical consulting company committed to providing innovative solutions to the challenges facing our industries. We pride ourselves on our...

  • Regulatory Affairs Expert

    hace 17 horas

    Barcelona, España Project Delivery Partners A tiempo completo

    Position Title: CMC RA Expert Location: Barcelona Type of Contract: Full-Time / On site PharmEng Technology, an Efor Group of Companies, is a leading pharmaceutical and biopharmaceutical consulting company committed to providing innovative solutions to the challenges facing our industries. We pride ourselves on our dedication to quality, safety, and...

  • Regulatory Affairs Expert

    hace 1 semana

    Barcelona, Barcelona, España Project Delivery Partners A tiempo completo

    Position Title: CMC RA ExpertLocation: BarcelonaType of Contract: Full-Time / On sitePharmEng Technology, an Efor Group of Companies, is a leading pharmaceutical and biopharmaceutical consulting company committed to providing innovative solutions to the challenges facing our industries. We pride ourselves on our dedication to quality, safety, and...

  • Regulatory Affairs Expert

    hace 3 días

    Barcelona, Barcelona, España Project Delivery Partners A tiempo completo

    Job Description: Position Title: CMC RA ExpertLocation: BarcelonaType of Contract: Full-Time / On sitePharmEng Technology, an Efor Group of Companies, is a leading pharmaceutical and biopharmaceutical consulting company committed to providing innovative solutions to the challenges facing our industries. We pride ourselves on our dedication to quality,...

  • Regulatory Affairs Manager

    hace 2 semanas

    Barcelona, España Hezuo Ltd A tiempo completo

    Regulatory Affairs Manager As Regulatory Affairs Manager , you’ll play a pivotal role in supporting the geographical expansion of a dietary supplement ingredient business . Based in Barcelona , you’ll coordinate regulatory activities that ensure timely and compliant product registrations, authorizations, marketing & scientific communication across...

  • REGULATORY AFFAIRS MANAGER

    hace 3 días

    Barcelona, España MCR International A tiempo completo

    BO- REGULATORY AFFAIRS SPECIALIST – NUTRACEUTICALS / DIETARY SUPPLEMENTSBARCELONACompañía 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...

  • Trainee Regulatory Affairs

    hace 1 semana

    Barcelona, España HARTMANN A tiempo completo

    En HARTMANN nos dedicamos a **ayudar**, **cuidar**, **proteger** y **crecer**. Apoyamos a los profesionales de la salud para que puedan concentrarse en lo que realmente importa: impactar positivamente en la vida de las personas. Creamos soluciones que marcan la diferencia, y con tu compromiso podrás desarrollarte profesionalmente cada día. En HARTMANN tu...

  • Regulatory Affairs Trainee

    hace 2 semanas

    Barcelona, España HARTMANN A tiempo completo

    Únete a nuestro equipo como **Regulatory Affairs Trainee** ESP-Mataró (Barcelona) Aprovecha la nueva oportunidad que te ofrece HARTMANN en el **Área de Regulatory Affairs**. **Responsabilidades** - En relación con las comunicaciones de puesta en el mercado a la AEMPS por cada producto sanitario que ponemos en el mercado: - Reunir la documentación...

  • REGULATORY AFFAIRS MANAGER

    hace 3 días

    Barcelona, España MCR International A tiempo completo

    BO- REGULATORY AFFAIRS SPECIALIST – NUTRACEUTICALS / DIETARY SUPPLEMENTS BARCELONA Compañía 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...

  • Cmc Regulatory Affairs Associate Director

    hace 2 días

    Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona, Spain (we requiere 3 days working from the office and 2 days working from home** Our **Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs** function delivers expert CMC regulatory input for projects spanning across the product lifecycle and leads the regulatory strategy for the development, manufacturing and testing of...