CMC RA Senior Specialist

hace 3 días

Barcelona, España Project Delivery Partners A tiempo completo

Join to apply for the CMC RA Senior Specialist - Barcelona role at Project Delivery Partners .Position Title: CMC RA Senior Specialist - BarcelonaLocation: 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 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 SummaryThe 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 ResponsibilitiesPrepare 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.QualificationsBachelor(s) or Master(s) 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 OfferCompetitive 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.#J-18808-Ljbffr

  • CMC RA Senior Specialist

    hace 2 semanas

    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...

  • CMC RA Senior Specialist

    hace 3 días

    Barcelona, España Project Delivery Partners A tiempo completo

    Job Description: 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...

  • CMC RA Senior Specialist

    hace 6 días

    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...

  • CMC RA Senior Specialist

    hace 6 días

    Barcelona, Barcelona, España Project Delivery Partners A tiempo completo

    Job Description: Position Title: CMC RA Senior Specialist - BarcelonaLocation: 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...

  • Senior CMC RA Specialist – Barcelona

    hace 3 días

    Barcelona, España Project Delivery Partners A tiempo completo

    A leading pharmaceutical consulting firm is seeking a Senior CMC RA Specialist in Barcelona. The candidate must have a Bachelor's or Master's degree in a relevant field and over 10 years of experience in Regulatory Affairs, focusing on Chemistry, Manufacturing, and Controls (CMC). Responsibilities include preparing documentation for regulatory compliance and...

  • CMC RA Senior Specialist

    hace 7 días

    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...

  • Senior CMC Regulatory Affairs Specialist

    hace 3 días

    Barcelona, España Project Delivery Partners Pte Ltd A tiempo completo

    A leading consulting firm in Barcelona seeks a dedicated Senior CMC RA Specialist. This on-site role focuses on ensuring regulatory compliance in Chemistry, Manufacturing, and Controls (CMC) documentation. The ideal candidate has over 10 years of experience in Regulatory Affairs within the pharmaceutical industry, strong knowledge of GMP and ICH guidelines,...

  • Senior CMC RA Expert — On-Site in Barcelona

    hace 3 días

    Barcelona, España Project Delivery Partners Pte Ltd A tiempo completo

    A leading pharmaceutical consulting firm in Barcelona seeks a Senior CMC RA Expert to ensure compliance of Chemistry, Manufacturing, and Controls (CMC) documentation. The expert will oversee alignment between regulatory dossiers and manufacturing practices, requiring fluent Spanish and English. Ideal candidates have over 10 years of experience in Regulatory...

  • Senior Regulatory Executive

    hace 7 días

    Barcelona, España G&L Healthcare Advisors A tiempo completo

    Contract: Permanent Full-Time Closing Date: 31/10/25 We are a specialist consultancy providing regulatory expertise to leading global pharmaceutical and healthcare organisations. We are currently seeking an experienced Senior Regulatory Executive (CMC RA Devices) to support one of our major clients on a contract basis. In this role, you will contribute to...

  • Cmc Regulatory Affairs Director

    hace 2 semanas

    Barcelona, España AstraZeneca A tiempo completo

    Are you a strategically focussed Regulatory CMC professional and would like to play an integral part in bringing life changing medicines to patients? If you are please read on! **About AstraZeneca** At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working...