CMC RA Senior Specialist

hace 1 semana

Barcelona, Barcelona, España Project Delivery Partners A tiempo completo

Position Title: CMC RA Senior Specialist - Barcelona

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 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 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...

  • qa senior specialist

    hace 1 semana

    Barcelona, Barcelona, España ASINFARMA A tiempo completo

    ASINFARMA is looking for a QA Senior Specialist & Qualified Person (QP) for one of our clients in the pharmaceutical industry(The company name, located in Barcelona city, will be disclosed only to shortlisted candidates.) Position RequirementsWe are seeking a profile with: Minimum 5 years of experience  in the pharmaceutical industry in roles such as  ...

  • Senior Payroll Specialist

    hace 1 semana

    Barcelona, Barcelona, España The Adecco Group A tiempo completo

    Únete a un grupo hotelero con más de 40 años de trayectoriaDesde Adecco colaboramos con una importante Grupo Hotelero, que destaca por su diversidad de servicios, compromiso con el crecimiento sostenible y visión internacional. Y estamos en búsqueda de un/aSenior Payroll Specialistpara incorporarse a sus oficinas centrales en Barcelona.¿Te apasiona el...

  • Global Product Sustainability Specialist

    hace 1 semana

    Barcelona, Barcelona, España Werfen A tiempo completo

    Job SummaryThe Global Product Sustainability Specialist is responsible for evaluating and implementing product sustainability regulations and requirements, as well as developing, executing, and overseeing global programs that promote product sustainability and stewardship across all technology centers and relevant sites.This position oversees the...

  • Senior Technical Support Specialist

    hace 1 semana

    Barcelona, Barcelona, España Duetto A tiempo completo

    About the CompanyDuetto, the industry-leading hospitality revenue management system, leads the way in helping hotels, resorts and casinos optimize revenue and boost profit. Our leading SaaS platform, expanding suite of products, and incredibly skilled team have been at the heart of our continued success and our ambition for future growth knows no...

  • Senior Talent Acquisition Specialist F/H

    hace 3 días

    Barcelona, Barcelona, España Freeland A tiempo completo

    L'entreprise Au sein du groupe freeland, notre société Mindquest s'agrandit Nous sommes une société de services de recrutement mettant en relation des entreprises avec les meilleurs professionnels de l'IT et de la finance.Au sein de nos site à Barcelone, nous avons deux opportunités de Senior Talent Acquisition Specialist à pourvoir pour...

  • Senior Escalation Specialist, Maintenance Operation Centre

    hace 1 semana

    Barcelona, Barcelona, España Amazon A tiempo completo

    The Senior Escalation Specialist serves as a technical expert and mentor within Amazon Maintenance Operations Centre (AMOC). This role combines advanced technical troubleshooting with operational guidance, focusing on complex escalations and process improvement initiatives. The position requires an experienced professional who can handle sophisticated...

  • Senior Payroll Specialist Spain

    hace 1 semana

    Barcelona, Barcelona, España Noatum A tiempo completo

    Noatum, part ofAD Ports Group,is a leading multinational company in maritime, logistics, and port services, recognized for its more than 50 years of activity, service excellence, and specialized staff.Our activity is divided into three main business areas:Noatum Maritime Services, focused on providing maritime services;Noatum Logistics, a comprehensive...