Regulatory Affairs Strategy Director
Company: Azza HealthCare Agency Agency
- Location: Utrecht, Netherlands
- Seniority: Director
- Employment type: Full-time
- Posted: 9 days ago
- Offer language: English
Job description
Role Overview
The Director, EU/ROW Regulatory Lead is a key member of the Global Regulatory Affairs team, responsible for overseeing regulatory activities related to clinical trial submissions in EU/ROW regions. This role involves representing Regulatory Affairs in Clinical Trial Teams, collaborating with CROs and stakeholders to ensure smooth progress, and serving as EU/ROW Regulatory Strategy Lead for multiple compounds, providing expert guidance on procedural and documentation requirements.
Key Responsibilities
- Lead and oversee complex clinical trial submission activities and represent RA in global teams.
- Develop and execute EU/ROW regulatory strategies, including preparing strategic documents like Briefing Packages, ODDs, and PIPs.
- Manage EMA and national Scientific Advice procedures, evaluate regulatory risks, and recommend mitigation strategies.
- Monitor regulatory guidelines, assess their impact, and maintain current knowledge of regulatory landscapes to inform development strategies.
Qualifications & Skills
- Bachelor’s degree in a scientific or health-related field; Master’s preferred.
- At least 8 years of Regulatory Affairs experience, especially in development phases up to global marketing applications.
- Experience leading health authority meetings, with a good understanding of drug development and EU regulatory processes.
- Strong project management, organizational, communication, and problem-solving skills.
- Ability to work independently, manage multiple projects, and collaborate effectively in a global environment.
- Experience in oncology/I&I and with PIPs or ROW markets is advantageous.
Personal Attributes
- Highly motivated, detail-oriented, and goal-driven.
- Excellent cross-functional teamwork and relationship-building skills.
- Adaptable to fast-changing environments with strong prioritization abilities.
