Associate Director, Regulatory Affairs

Job Summary

Executing regulatory oversight for advertising, promotion, and labeling, the full-time Associate Director, Regulatory Affairs will develop and implement regulatory strategies for product communications while ensuring compliance with US FDA, EMA, and global regulations in a remote setting.

Key responsibilities

• Serve as regulatory lead for promotional and medical review committees, providing guidance on claims and communications
• Provide strategic regulatory guidance on the development of promotional and educational materials across various channels
• Lead interactions with the US FDA and manage responses to enforcement letters and advisory comments

Required qualifications

• BS or MS with requisite experience; advanced life sciences or medical degree (MD, PhD, PharmD) preferred
• 8+ years of biopharmaceutical Regulatory experience, including at least 6 years in advertising and promotion
• Expertise in FDA promotional regulations and OPDP interactions
• Demonstrated product launch and lifecycle management experience; growth-stage biotech experience preferred
• Experience with Veeva PromoMats or similar systems