Regulatory Affairs Associate Director

Job Summary

Leading regulatory review and approval processes for commercial materials, the full-time salaried Regulatory Affairs Associate Director will coordinate interactions with the FDA Office of Prescription Drug Promotion, manage promotional review systems, and ensure compliance with advertising and promotional regulations in a remote environment.

Key responsibilities

• Review and approve product labeling and promotional materials to ensure compliance with FDA regulations and company policies
• Lead the promotional review processes and manage operational systems including Veeva Vault PromoMats
• Develop and implement regulatory strategies for labeling and promotion of new and existing products

Required qualifications

• Bachelor's degree with a minimum of 7 years of experience in Regulatory Affairs or a related discipline
• Thorough knowledge of FDA regulations and guidelines related to advertising and promotional materials
• Experience in managing complex regulatory issues and providing clear risk-based guidance
• Proven ability to communicate effectively with cross-functional teams and regulatory authorities
• Strong organizational skills and the ability to adapt to a rapidly changing environment