Senior Director Regulatory Affairs

Position Summary

12 – 24 Month Contract – Home Based Europe.

My Client a Clinical Stage Oncology Biotech, has filed their BLA and are now aiming for their MA in 2026. The role, Senior Director, will be the EU Lead and take responsibility inline with the Vice President, to ensure successful filing with the EMA.

This individual will serve as the primary liaison to the European Medicines Agency (EMA) and other regulatory bodies, ensuring compliance with regional and global regulatory requirements. The role requires strong expertise in biologics development and experience leading major regulatory submissions.

Key Responsibilities

• Serve as the primary point of contact with EMA and other European health authorities.
• Lead and manage the Marketing Authorization Application (MAA)
• Provide oversight and strategic direction for regulatory vendors and Contract Research Organizations (CROs).
• Act as the regulatory project lead for assigned programs, ensuring adherence to European regulatory requirements.
• Support commercialization efforts and ensure regulatory alignment for product launches in Europe.
• Stay informed of regulatory policies and guidance in Europe, assessing their impact on business strategies.
• Develop and implement regulatory strategies for European and global markets, ensuring compliance throughout product development stages.
• Lead cross-functional teams and manage regulatory project timelines effectively.
• Mentor and guide junior staff supporting regulatory initiatives.

Required Qualifications & Experience

• Advanced degree in Life Sciences (Master’s required; Ph.D., MD, or PharmD preferred).
• 10-15 years of experience in the biopharmaceutical industry
• Hands-on experience in MAA/CMA submissions with a successful track record of approvals.
• Proven experience in biologics development and leading formal meetings with EMA and other regulatory agencies.
• Strong understanding of EMA submission requirements, content, and technical guidelines.
• Ability to work in a fast-paced environment with shifting priorities and high-pressure deadlines.
• Excellent communication and interpersonal skills, with the ability to influence stakeholders at all levels.