Director, Regulatory Affairs – EU/ROW Strategy (Oncology)

Sotalent; Utrecht; On-site; EUR 96,000 - 144,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory strategy

Clinical development

EMA meetings

Regulatory submissions

Project management

Cross-functional

International regulatory

Education

Bachelor's degree in science/health

Job description

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.