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Associate Specialist, Regulatory Affairs
Abacus MedicineRegulatory Affairs Specialist managing submissions and approvals in the South of Europe HUB. Focusing on operational execution, process optimization, and collaboration with diverse teams.
Tech Stack
Tools & technologiesCloud
About the role
Key responsibilities & impact- Acquire and maintain parallel trading licenses, including dossier preparation, submissions, and lifecycle management
- Prepare and proofread packaging materials, artwork files, mock-ups, item lists, and regulatory documentation
- Communicate with competent authorities and stakeholders across assigned markets
- Participate in continuous improvement initiatives and optimization of processes and systems
- Support onboarding and training of colleagues within the team
- Evaluate regulatory legislation changes and contribute to operational implementation
- Participate in projects as an operational SME within Regulatory Affairs
- Support maintenance of SOPs, working instructions, and guidelines
Requirements
What you’ll need- 5+ years of experience within Regulatory Affairs
- A Master’s degree or PhD within Pharmacy, Health Sciences, Life Sciences, or similar
- Alternatively 8+ years of relevant Regulatory Affairs experience
- Strong understanding of EU regulatory requirements and procedures
- Professional proficiency in English
- Professional proficiency in either Spanish and Portuguese / Italian
- Experience working with packaging materials and documentation in a regulated environment
- A structured and detail-oriented approach combined with a proactive mindset
- Experience working with Adobe Creative Cloud in a technical or regulated environment is an advantage
Benefits
Comp & perks- An international workplace with colleagues across Europe
- A role with both operational responsibility and influence on improvements and ways of working
- A collaborative and supportive team environment
- Opportunities for professional and personal development
- The possibility to work closely with multiple stakeholders and markets across Europe
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory documentationpackaging materialsdossier preparationlifecycle managementEU regulatory requirementsSOPsworking instructionsguidelinescontinuous improvementoperational implementation
Soft Skills
communicationdetail-orientedproactive mindsetteam collaborationstakeholder engagementtrainingprocess optimizationproject participationevaluationstructured approach
Certifications
Master’s degreePhD