Associate Specialist, Regulatory Affairs

Responsibilities

• 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

• 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