Strategic Regulatory Ad & Promo Director

EPM Scientific; Boston (MA); Sur place; USD 140 000 - 190 000; Plein temps

Résumé du poste

EPM Scientific is seeking an Associate Director of Regulatory Affairs Advertising & Promotion in the Greater Boston area. This role provides regulatory oversight for commercial communications, promotional materials, and product labeling, acting as a key partner to cross-functional teams to ensure compliance with FDA and industry standards.

The position governs promotional review processes, submissions, and labeling strategy, collaborating with regulatory, legal, and marketing stakeholders to

Qualifications

• Bachelor's degree with 8+ years of regulatory affairs experience; Master's with 6+ years; PhD with 5+ years.
• Experience supporting advertising and promotion, product labeling, regulatory strategy, or commercial regulatory affairs.
• Strong understanding of FDA regulations and compliance governing promotional communications and product labeling.

Responsabilités

• Provide strategic regulatory guidance for advertising and promotion in support of commercial objectives.
• Serve as regulatory representative on cross-functional review committees evaluating promotional materials.
• Review and oversee promotional materials, product communications, advertising campaigns, and digital content.
• Develop and implement regulatory strategies related to labeling, advertising, and promotion for marketed products.
• Assess promotional claims, messaging, and scientific content for consistency with labeling and risk communication.
• Collaborate with commercial, medical, legal, and compliance teams to evaluate regulatory risks and provide recommendations.
• Develop regulatory assessments and position statements for promotional and labeling activities.
• Provide training to internal stakeholders on promotional compliance requirements and review processes.

Connaissances

Regulatory affairs

Advertising & promotion

FDA regulations

Product labeling

Cross-functional collaboration

Regulatory strategy

Communication

Project management

Formation

Bachelor's degree in a life sciences field

Master's degree (preferred)

PhD (optional)

Description du poste

EPM Scientific is seeking an Associate Director of Regulatory Affairs Advertising & Promotion in the Greater Boston area. This role provides regulatory oversight for commercial communications, promotional materials, and product labeling, acting as a key partner to cross-functional teams to ensure compliance with FDA and industry standards.

The position governs promotional review processes, submissions, and labeling strategy, collaborating with regulatory, legal, and marketing stakeholders to