EU Regulatory Affairs Specialist — Parallel Trade

Abacus Medicine Group; Alkmaar; Hybrid; EUR 55,000 - 75,000; Full time

Job summary

Abacus Medicine Group in Alkmaar is seeking an RA Associate Specialist to independently manage regulatory activities for assigned End Markets. You will ensure dossiers, packaging materials, and records meet EU requirements and internal procedures, delivering accurate and timely results with autonomy.

You will collaborate with Regulatory Affairs NL Hub, QA, Product Development, and Operations, and engage with health authorities and service providers.

Qualifications

• Bachelor’s/Master’s/PhD in Pharmacy or Life Sciences or related field, or 5+ years regulatory experience.
• Strong understanding of EU regulatory requirements and procedures.
• Professional proficiency in Dutch and English, written and spoken.
• Excellent communication and stakeholder management skills.

Responsibilities

• Prepare, coordinate, and submit national new parallel-trading license applications for assigned products and End Markets.
• Maintain existing licenses through lifecycle management, including dossier updates and submissions.
• Prepare artwork files, mock-ups, and other packaging materials, and assess whether existing materials can be reused.
• Prepare and validate item lists, and proofread packaging components, application files, and item lists.
• Own TMH notifications for assigned products and markets, including documentation review, regulatory assessment, and follow-up.
• Maintain complete, accurate, and compliant regulatory records, submissions, and supporting documentation.
• Communicate with competent authorities and relevant internal and external stakeholders.
• Monitor relevant legislation and assess the impact of regulatory changes.
• Author, edit, and review SOPs, working instructions, and guidelines in line with EU requirements and internal procedures.
• Escalate compliance risks, critical issues, and significant deviations to the Regulatory Affairs Manager in a timely manner.
• Plan and prioritize multiple activities, monitor progress, and adjust your approach to meet deadlines.
• Participate as an operational subject-matter expert in process, system, and operational improvement projects.

Skills

Regulatory Affairs

Dutch language

English language

Communication

Multitasking

MS Office

Adobe CC

Quality systems

Education

Regulatory Affairs experience

Bachelor/Master/PhD in Pharmacy or Life Sciences

Tools

Microsoft Office

Adobe Creative Cloud

Job description

Abacus Medicine Group in Alkmaar is seeking an RA Associate Specialist to independently manage regulatory activities for assigned End Markets. You will ensure dossiers, packaging materials, and records meet EU requirements and internal procedures, delivering accurate and timely results with autonomy.

You will collaborate with Regulatory Affairs NL Hub, QA, Product Development, and Operations, and engage with health authorities and service providers.