Director of Regulatory Affairs

QTC Recruitment; Netherlands; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Competitive compensation package

Long-term development potential

Dynamic working environment

Job summary

QTC Recruitment is seeking an experienced Regulatory Affairs Director in the Netherlands to support EU/UK regulatory activities for an international pharmaceutical company. This high-visibility role requires a senior regulatory professional to serve as the local contact for European authorities and manage regulatory submissions.

Ideal candidates have 10+ years of experience in regulatory affairs and a strong understanding of EU procedures. Join a dynamic, growth-oriented environment with competitive compensation and development potential.

Qualifications

• 10+ years of pharmaceutical regulatory affairs experience.
• Strong expertise in EU regulatory procedures and submission pathways.
• Excellent stakeholder management and cross-cultural communication skills.

Responsibilities

• Develop and execute EU/UK regulatory strategies for pharmaceutical products.
• Act as the primary local contact for regulatory agencies.
• Lead and coordinate regulatory submissions including MAAs and CTAs.
• Provide regulatory guidance to internal global stakeholders.
• Assess regulatory risks and propose mitigation strategies.

Skills

Pharmaceutical regulatory affairs experience

EU regulatory procedures

Stakeholder management

Cross-cultural communication

Job description

QTC are partnered with an international pharmaceutical company with expanding operations across Europe in seeking an experienced Regulatory Affairs Director to support and drive EU/UK regulatory activities. The organization has a strong presence across Asian and global markets and is continuing to build its European commercial and regulatory footprint.

This is a high-visibility individual contributor role for a senior regulatory professional who can serve as the local regulatory contact point for European authorities, while partnering closely with international headquarters and cross‑functional global teams. The position is ideal for someone who enjoys strategic regulatory ownership, hands‑on submission management, and operating within an entrepreneurial, internationally expanding environment.

Key Responsibilities:

• Develop and execute EU/UK regulatory strategies for pharmaceutical products across development and lifecycle stages
• Act as the primary local contact point for regulatory agencies including EMA, MHRA, and EU competent authorities
• Lead and coordinate regulatory submissions including MAAs, CTAs, variations, renewals, and scientific advice packages
• Ensure maintenance and lifecycle management of existing product registrations across European markets
• Provide regulatory guidance to internal global stakeholders across CMC, clinical, quality, and commercial functions
• Assess regulatory risks and propose mitigation strategies to support timely approvals and compliance
• Collaborate closely with international teams to ensure high‑quality dossiers and successful submissions
• Track evolving EU/UK regulatory requirements and evaluate impact on company portfolio and strategy
• Support regulatory communications, agency correspondence, and inspection readiness activities as required

Candidate Profile:

• 10+ years of pharmaceutical regulatory affairs experience
• Strong expertise in EU regulatory procedures and submission pathways (MRP/DCP/CP)
• Proven experience with CTD/eCTD submissions and lifecycle management activities
• Hands‑on experience interacting with EMA, MHRA, and/or European competent authorities
• Ability to operate independently in a senior individual contributor capacity
• Strong understanding of EU regulatory strategy and post‑approval maintenance activities
• Excellent stakeholder management and cross‑cultural communication skills
• Experience within generics, specialty pharma, injectables, or oncology is advantageous
• Experience working with Asian/global headquarters or international matrix organizations is highly preferred

Why Join:

• Opportunity to play a key role in a growing international pharmaceutical business
• High level of ownership and visibility within European operations
• Exposure to global regulatory strategy and cross-border collaboration
• Dynamic and entrepreneurial working environment with international growth ambitions
• Competitive compensation package and long‑term development potential