Director, Regulatory Affairs

As the Director, Regulatory Affairs, you will develop and execute global regulatory strategies for early-stage and advanced therapy products, preparing key submissions and ensuring alignment with U.S. and international requirements.

Requirements

• Doctorate level or masters degree required (MD or PhD, MS in Science/Biotechnology/Regulatory or equivalent)
• At least 10 years of relevant experience required
• Experience in gene therapy preferred
• Demonstrated ability to lead and motivate people
• Ability to proactively predict issues and solve problems
• Flexible, resilient, resourceful, entrepreneurial, innovative, and conducts all activities in a highly ethical manner
• Experience with global regulatory quality requirements
• Proactive approaches to problem-solving with strong decision-making capability
• Strong written and oral communication skills; comfortable communicating with and building relationships with various stakeholders including external partners and health authorities
• Experience with preparation of high-quality FDA/EMA submission documentation and Health Authority meeting preparations preferred

Benefits

• Market-competitive salaries
• Annual bonus program
• Education assistance
• Retirement plan with employer match
• Stock options at all levels
• Summer hours