Director of Regulatory Affairs

Sotalent; Utrecht; Presencial; EUR 96 000 - 144 000; Tempo integral

Resumo da oferta

Sotalent in Utrecht, Netherlands, seeks a Director of Regulatory Affairs to lead EU/ROW strategies for oncology and serious diseases. The role oversees complex submissions and engages European authorities, shaping development programs and regulatory pathways across global markets.

You will work with cross-functional teams, CROs, and regulators on PA/ODD/PIP planning, scientific advice meetings with EMA, and ongoing compliance with evolving EU and international requirements.

Qualificações

• Bachelor's degree in science or health-related field.
• Minimum 8 years Regulatory Affairs experience in clinical development to MA submissions.
• Experience leading EMA or health authority meetings.
• Strong knowledge of EU regulatory procedures.
• Ability to manage multiple regulatory projects independently.
• Excellent cross-functional communication.
• Experience in international/global regulatory environment.

Responsabilidades

• Develop and execute EU/ROW regulatory strategies for clinical development programs.
• Oversee complex clinical trial submissions and ensure regulatory compliance.
• Represent Regulatory Affairs on clinical trial and global regulatory teams.
• Lead preparation of regulatory documents including Briefing Packages, ODDs, and PIPs.
• Plan and lead scientific advice meetings with EMA and national authorities.
• Provide regulatory guidance to cross-functional 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 submissions.
• Support regulatory process improvements and maintain guidelines compliance.

Conhecimentos

Regulatory strategy

Clinical development

EMA meetings

Regulatory submissions

Project management

Cross-functional

International regulatory

Formação académica

Bachelor's degree in science/health

Descrição da oferta de emprego

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.