Senior Regulatory Affairs Manager - EU MAH & LCM Expert

Galderma; Amsterdam; On-site; EUR 90,000 - 140,000; Full time

Job summary

Galderma in Amsterdam is seeking a Senior Regulatory Affairs Manager to lead MAH oversight of regulatory activities for pharma products and some cosmetics. You will drive regulatory intelligence, lifecycle management, and liaise with health authorities across the EU.

This role requires a scientific degree, 10 years in RA, and strong leadership to coordinate global projects with external partners. Fluent English and Dutch are essential; you will influence cross-functional teams and ensure

Qualifications

• Scientific degree or Pharmacist qualification.
• 10 years of Regulatory Affairs experience, including Lifecycle Management activities and Health Authority inspections.
• Experience managing outsourced Regulatory Dossier activities and international projects.
• Ability to deliver results in a fast-paced environment with tight deadlines.
• Experience interacting with regulatory agencies and contributing to global regulatory strategies.
• Strong cross-functional collaboration and ability to influence and motivate teams.
• Proven transversal leadership skills.
• Excellent organizational, planning, analytical, and problem-solving skills.
• Fluent in English and Dutch.

Responsibilities

• MAH oversight of PV/Quality and RA activities with focus on pharmaceutical products.
• Oversee LCM activities and use of GSA NL in development for pharmaceuticals.
• Be the regulatory contact for GSA NL and HA inspections.
• Lead Regulatory Intelligence and impact analysis of EU pharma regulations.
• Coordinate with Regulatory Service Providers and improve processes.
• Ensure regulatory documents are tracked in EDMS and RA database.

Skills

Cross-functional collaboration

Leadership

organizational skills

Planning

Analytical skills

Problem solving

Communication skills

English Dutch fluency

Education

Scientific degree or Pharmacist qualification

Job description

Galderma in Amsterdam is seeking a Senior Regulatory Affairs Manager to lead MAH oversight of regulatory activities for pharma products and some cosmetics. You will drive regulatory intelligence, lifecycle management, and liaise with health authorities across the EU.

This role requires a scientific degree, 10 years in RA, and strong leadership to coordinate global projects with external partners. Fluent English and Dutch are essential; you will influence cross-functional teams and ensure