Associate Director, Regulatory Affairs

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Regulatory Affairs based in United States.

• The Associate Director, Regulatory Affairs is a key member of a global regulatory organization, helping shape and execute regulatory strategies across the product lifecycle.
• You will serve as a trusted advisor and business partner, with a strong focus on US regulatory activities and FDA engagement.
• The role spans pre-approval, filing, launch, distribution, and post-approval activities for innovative medicines.
• You will work closely with clinical, medical, legal, quality, pharmacovigilance, and commercial teams to support critical business decisions.
• As a primary regulatory contact, you will lead agency interactions and contribute to high-quality submissions and responses.
• The position combines strategic thinking with hands-on execution in a fast-paced, science-driven environment.
• It offers the opportunity to influence regulatory strategy, support successful product launches, and contribute to medicines addressing significant patient needs.