Director, Regulatory Affairs - Advertising & Promotion

Green Key Resources; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Green Key Resources in the United States is seeking a Director of Regulatory Affairs, Advertising & Promotion to lead strategic regulatory oversight of promotional materials for marketed products. You will partner with Marketing, Medical Affairs, Legal and Commercial teams to ensure communications comply with FDA regulations and labeling.

The role includes chairing cross-functional review committees, staying ahead of regulatory guidance, and shaping advocacy-regulatory strategy for advertising

Qualifications

• Bachelor’s degree in a health or science-related field; advanced degree preferred.
• 10+ years of Regulatory Advertising & Promotion experience within the pharmaceutical or biotech industry.
• Deep understanding of clinical trial design and interpretation of clinical data.
• Strong communication skills and ability to influence across all levels of the organization.
• Ability to anticipate emerging trends and shape regulatory strategy accordingly.

Responsibilities

• Oversee and review product and disease-state materials to ensure compliance with FDA regulations and approved labeling.
• Provide strategic regulatory guidance to internal stakeholders and offer solutions to complex promotional challenges.
• Serve as a core member—and often chair—of cross-functional review committees.
• Maintain expert knowledge of FDA laws, regulations, and guidelines related to advertising and promotion.
• Train internal teams on promotional regulatory requirements.
• Lead efforts to streamline and optimize review processes.
• Act as primary contact with regulatory authorities for assigned products, including submission of promotional materials.

Skills

Communication skills

Cross-functional collaboration

Regulatory affairs knowledge

Strategic thinking

Education

Bachelor’s degree in health/science field

Job description

A leading biopharmaceutical organization is seeking an experienced Director of Regulatory Affairs, Advertising & Promotion to join its growing Regulatory function. This role is ideal for a seasoned regulatory professional who thrives in cross-functional environments and enjoys shaping compliant, strategic promotional communication for marketed products.

About the Role

In this position, you will serve as a key regulatory partner to Marketing, Medical Affairs, Legal, and Commercial teams. You’ll provide expert guidance on advertising and promotion activities, ensuring all external communications align with FDA regulations, current industry standards, and product labeling. This role also includes leadership within internal review committees and direct interaction with regulatory authorities.

Key Responsibilities

• Oversee and review product and disease-state materials to ensure compliance with FDA regulations and approved labeling.
• Provide strategic regulatory guidance to internal stakeholders and offer solutions to complex promotional challenges.
• Serve as a core member—and often chair—of cross-functional review committees.
• Maintain expert knowledge of FDA laws, regulations, and guidelines related to advertising and promotion.
• Train internal teams on promotional regulatory requirements.
• Lead efforts to streamline and optimize review processes.
• Act as primary contact with regulatory authorities for assigned products, including submission of promotional materials.

Qualifications

• Bachelor’s degree in a health or science-related field; advanced degree preferred.
• 10+ years of Regulatory Advertising & Promotion experience within the pharmaceutical or biotech industry.
• Deep understanding of clinical trial design and interpretation of clinical data.
• Strong communication skills and ability to influence across all levels of the organization.
• Ability to anticipate emerging trends and shape regulatory strategy accordingly.