Full-Time Associate Director, Regulatory Affairs

The Role: The Associate/Director, Regulatory Affairs will join a highly motivated team, shaping regulatory strategies for oncology products through development phases.

What You’ll Do:

• Develop regulatory strategies for oncology programs (from FIH to post-marketing).
• Provide regulatory solutions and guidance to cross-functional teams.
• Monitor global regulatory changes affecting asset development.
• Offer tactical support and operational expertise.
• Ensure compliance of regulatory strategies and submissions.
• Assess project plans and timelines; manage staff.
• Contribute to process improvement.

What You’ll Bring:

Required Qualifications:

• B.S./M.S. and 8+ years of regulatory affairs experience in pharmaceuticals.
• 5+ years of global development and submission experience.
• Advanced knowledge of oncology drug development regulations (US and EU).
• Experience filing INDs and/or NDAs with FDA and other regulatory bodies.

Preferred Qualifications:

• Strategic thinking and innovative problem-solving skills.
• Strong verbal and written communication skills.
• Regulatory team management experience.

What is the last date for applying to the job?

Which countries are accepted for this remote job?