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

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
It is an advantage if you also have experience working with Adobe Creative Cloud in a technical or regulated environment.

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

Associate Specialist, Regulatory Affairs

Key skills