Overview:

The Director will serve as the EU regulatory lead, partnering with global regulatory teams and affiliates to drive EU-specific regulatory strategies across the product lifecycle. This role focuses on strategic guidance for clinical development, regulatory submissions, and early patient access, ensuring alignment with EMA requirements and global objectives.

Key Responsibilities:

• Lead EU regulatory strategy from early to late-stage development.
• Act as primary liaison with the EMA and other European regulatory bodies.
• Advise on regulatory pathways and risk mitigation strategies.
• Support regulatory submissions and scientific advice meetings.
• Ensure regulatory strategies support market access and business goals.
• Maintain up-to-date knowledge of EU regulations and contribute to global regulatory planning.
• Represent Regulatory Affairs on cross-functional teams.

Qualifications:

• Advanced degree in Life Sciences; regulatory specialization preferred.
• 8 years of regulatory experience in pharma/biotech or health authority.
• Experience in both large pharma and small biotech environments is ideal.
• Proven success in EU product registrations and innovative regulatory strategies.
• Strong leadership, communication, and cross-functional collaboration skills.
• Orphan drugs, PIP expertise is an asset