SR. REGULATORY AFFARIS CMC

Job Title: Sr. Regulatory Affairs Specialist – RA-CMCLocation: Barcelona (50% home-based)Division: Life SciencesIntroduction to Oxford Global Resources:Oxford Global Resources is a trusted partner for providing specialized staffing and consulting solutions worldwide. With a focus on delivering quality, we connect highly skilled professionals to critical roles in the life sciences, healthcare, IT, and engineering sectors. Our expertise ensures agility and precision for companies looking to strengthen their teams and projects.Overview:Join Oxford’s exclusive partnership with a leading pharmaceutical company headquartered in Barcelona. This is an exciting opportunity to contribute to global regulatory affairs in a centralized, growth-driven organization committed to innovation in healthcare.Key Responsibilities:Regulatory Insight & Expertise: Provide expert advice to multidisciplinary teams on CMC/Quality regulations for successful approvals and compliance.Documentation & Submission: Prepare technical CMC documents, including MAAs, post-approval variations, IMPDs, and responses to regulatory authority questions.Global Collaboration: Coordinate CMC activities for portfolio expansion across multiple territories (LATAM, APAC, EMA).Business Development: Evaluate opportunities from a CMC perspective in collaboration with internal and external stakeholders.Compliance: Ensure adherence to international regulatory requirements and contribute to SOP development.Cross-functional Support: Build strong collaborations with Quality Assurance, Supply Chain, and Manufacturing Sites (CMOs).Required Qualifications & Skills:Education: University degree in Life Sciences, preferably in Chemistry or Pharmacy.Experience:Minimum 5 years of experience in Regulatory CMC for pharmaceutical products.Proven expertise in EU and international submissions, including successful regulatory approvals and lifecycle management.Strong CMC technical knowledge with a strategic regulatory mindset.Languages: Proficiency in English is essential.Preferred Knowledge: Regulatory frameworks for medical devices and food supplements.Why Apply?This role provides an opportunity to work with an innovative pharmaceutical leader driving impactful projects globally. You’ll collaborate with high-performing teams, influence critical regulatory processes, and contribute to expanding healthcare solutions in growing markets.For more details or to apply, connect with us directly!