EU Regulatory Affairs Lead (MAH) & Lifecycle Expert

Galderma S.A. Dutch Branch; Amsterdam; On-site; EUR 90,000 - 130,000; Full time

Job summary

Galderma S.A. Dutch Branch is seeking a Senior Regulatory Affairs Manager in Amsterdam to oversee MAH regulatory activities for pharmaceutical products and contribute to lifecycle management across EU jurisdictions.

You will act as the regulatory point of contact for Health Authority inspections, lead regulatory intelligence efforts, and coordinate strategy and submissions with cross-functional teams in a fast-paced global environment. Fluency in English and Dutch is required.

Qualifications

• Scientific degree (BSc, MSc, PhD) or Pharmacist qualification.
• 10 years of experience in Regulatory Affairs, including Lifecycle Management 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.
• Fluent in English and Dutch.

Responsibilities

• MAH responsibilities with global oversight for pharmaceutical products.
• Be the point of contact for Health Authority inspections and regulatory sessions.
• Lead Regulatory Intelligence activities focusing on European regulations.
• Perform lifecycle management activities for centrally authorized products.
• Coordinate regulatory strategy and dossier preparation with core documents.

Skills

Regulatory Affairs

Lifecycle Management

Health Authority liaison

Regulatory Strategy

Regulatory Intelligence

Cross-functional leadership

English & Dutch

Education

Scientific degree or Pharmacist qualification

Job description

Galderma S.A. Dutch Branch is seeking a Senior Regulatory Affairs Manager in Amsterdam to oversee MAH regulatory activities for pharmaceutical products and contribute to lifecycle management across EU jurisdictions.

You will act as the regulatory point of contact for Health Authority inspections, lead regulatory intelligence efforts, and coordinate strategy and submissions with cross-functional teams in a fast-paced global environment. Fluency in English and Dutch is required.