Regulatory Affairs Expert

hace 1 semana

Barcelona, 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.
  • 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.

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