Key Skills

Job Description

Role Overview The position is for a Director, EU/ROW Regulatory Lead within the Global Regulatory Affairs team. The role involves representing Regulatory Affairs (RA) in Clinical Trial Teams, overseeing clinical trial submission activities, and working closely with CROs and internal stakeholders to ensure regulatory progress in EU/ROW markets. The candidate may serve as the EU/ROW Regulatory Strategy Lead for multiple compounds, providing expertise on procedural matters and documentation to optimize regulatory strategies. The role requires developing and executing regulatory strategies, preparing strategic documents, and leading EMA or national scientific advice procedures. Monitoring regulatory guidelines, assessing risks, and maintaining knowledge of evolving regulations are essential. The position demands a proactive, detail-oriented professional with strong project management and cross-functional collaboration skills, capable of working independently and in a global team environment. Qualifications & Skills Bachelor’s degree or higher in a scientific or health-related field; Master’s preferred. At least 8 years of Regulatory Affairs experience, especially in development phases and submissions. Experience with complex clinical submission strategies, health authority meetings, and EU regulatory procedures. Knowledge of oncology, I&I, PIPs, and ROW markets is advantageous. Strong organizational, communication, and problem-solving skills with the ability to prioritize in a fast-paced environment. Excellent teamwork, relationship-building, and independent project leadership abilities. Key Duties Lead and oversee clinical trial submissions and regulatory activities. Develop and implement EU/ROW regulatory strategies. Prepare strategic regulatory documents and lead discussions with regulatory authorities. Evaluate regulatory risks and advise cross-functional teams. Stay current with regulatory guidelines and landscape changes. This role offers a challenging opportunity to contribute to innovative cancer treatments within a dynamic, collaborative environment focused on making a meaningful impact on patients' lives.

Core Responsibilities

Lead clinical trial submissions and develop and execute regulatory strategies for EU and rest-of-world markets. Prepare strategic documents, lead regulatory authority discussions, assess risks, and advise cross-functional teams on regulatory requirements and changes.

Requirements

Requires a bachelor's degree or higher in a scientific or health-related field, with a master's degree preferred, and at least eight years of Regulatory Affairs experience. Candidates should have experience with development-phase submissions, complex clinical submission strategies, health authority meetings, and EU regulatory procedures; oncology, I&I, PIPs, and rest-of-world market knowledge are advantageous.