Key Skills

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.

Core Responsibilities

Lead complex clinical trial submission activities in EU/ROW regions and represent Regulatory Affairs in global teams. Develop regulatory strategies and strategic documents, manage scientific advice procedures, assess regulatory risks, and monitor guidelines to inform development plans.

Requirements

Requires a bachelor's degree in a scientific or health-related field, with a master's preferred, and at least eight years of Regulatory Affairs experience. Candidates should have experience leading health authority meetings and knowledge of drug development and EU regulatory processes, along with strong project management, communication, and collaboration skills.