Associate Specialist, Regulatory Affairs

Abacus Medicine; Madrid; On-site; EUR 45,000 - 70,000; Full time

Job summary

Jobtailor in Madrid is seeking a seasoned Regulatory Affairs expert to acquire and manage EU licenses, prepare dossiers, and ensure lifecycle integrity across markets. You will review packaging materials and regulatory documentation, interact with authorities, and contribute to continuous process improvements while mentoring colleagues.

The ideal candidate has 5+ years in Regulatory Affairs, a Master’s or PhD in Life Sciences, and strong English; Spanish/Portuguese or Italian language skills are

Qualifications

• Master’s degree or PhD in Pharmacy, Health Sciences, Life Sciences, or similar.
• 8+ years of relevant Regulatory Affairs experience.
• Strong understanding of EU regulatory requirements and procedures.
• Professional proficiency in English.
• Professional proficiency in Spanish and Portuguese or Italian.
• Experience with packaging materials and documentation in a regulated environment.
• Structured and detail-oriented approach with a proactive mindset.
• Experience with Adobe Creative Cloud in a regulated environment is an advantage.

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.

Skills

Regulatory affairs

English

Spanish

Portuguese

Italian

Attention to detail

Proactive mindset

Adobe Creative Cloud

Education

Master’s degree or PhD in Pharmacy/Health Sciences/Life Sciences

8+ years of Regulatory Affairs experience

Tools

Adobe Creative Cloud

Job description

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