Director of Regulatory Affairs

Director, Regulatory Affairs – EU/ROW Strategy

Location:

Utrecht, Netherlands
Salary:  €96,000–€144,000 gross annually
Work Arrangement:  Not specified
Industry:  Biotechnology | Pharmaceuticals
About the Role  An opportunity is available for an experienced  Director of Regulatory Affairs  to lead European and Rest of World (EU/ROW) regulatory strategies within an international biotechnology organisation focused on oncology and serious diseases.
This senior position involves overseeing complex clinical trial submissions, developing regulatory strategies for pharmaceutical development programmes, and engaging with European regulatory authorities.

Key Responsibilities   Develop and execute  EU/ROW regulatory strategies  for clinical development programmes.
Oversee complex clinical trial submissions and ensure regulatory compliance.
Represent Regulatory Affairs on clinical trial and global regulatory teams.
Lead preparation of regulatory documentation, including  Briefing Packages, Orphan Drug Designations (ODDs), and Paediatric Investigation Plans (PIPs) .
Plan and lead scientific advice meetings with the  European Medicines Agency (EMA)  and national health authorities.
Provide regulatory guidance to cross-functional clinical development teams.
Identify regulatory risks and develop mitigation strategies.
Monitor evolving European and international regulatory requirements.
Collaborate with CROs and internal stakeholders to ensure timely regulatory submissions.
Support regulatory process improvements and maintain compliance with applicable guidelines.

Required Qualifications & Experience   Bachelor's degree in a scientific or health-related discipline, or equivalent.
Minimum 8 years of Regulatory Affairs experience , preferably covering clinical development through marketing authorisation submissions.
Experience developing and executing complex clinical submission strategies.
Previous experience leading meetings with the  EMA or other health authorities .
Strong understanding of pharmaceutical drug development and  EU regulatory procedures .
Excellent project management, organisational, and problem-solving skills.
Ability to manage multiple regulatory projects independently.
Strong communication and cross-functional stakeholder management capabilities.
Experience working in an international or global regulatory environment.

Preferred Qualifications   Regulatory Affairs experience in  oncology or immunology and inflammation (I&I) .

Experience with  Paediatric Investigation Plans (PIPs) .
Knowledge of regulatory development and submission requirements in Rest of World markets.
Base salary:  €96,000–€144,000 gross annually.
Eligibility for discretionary bonuses and long-term incentives.
Pension.
Health insurance and wellness benefits.
Paid time off.
Employee support programmes.
Contract Information  The position is based in Utrecht, Netherlands. The stated policy for permanently budgeted hires in the Netherlands is an initial  12-month fixed-term contract , with potential conversion to indefinite employment subject to performance and business conditions.