Senior Director of Regulatory Affairs

Job Summary

Driving global regulatory strategy, the full-time Senior Director of Regulatory Affairs will manage regulatory submissions and interactions with health authorities while collaborating with cross-functional teams to ensure compliance and accelerate product development in a remote setting.

Key responsibilities

• Develop and own global regulatory strategies for pipeline and marketed products throughout their lifecycle
• Lead cross-functional development teams, aligning regulatory planning with clinical and commercial objectives
• Oversee major regulatory filings and ensure compliance with eCTD standards and submission readiness

Required qualifications

• Bachelor's degree in life sciences, pharmacy, chemistry, or related field; advanced degree preferred
• 12+ years of regulatory affairs experience in the pharmaceutical, biotechnology, or medical device industry
• Proven success in leading BLA, NDA, or MAA submissions from initiation through approval
• Deep expertise in FDA regulations and guidance, with knowledge of EMA and other regulatory frameworks
• Strong leadership skills with experience managing and developing teams of regulatory professionals