Global Regulatory Ad & Promo Associate Director

Moderna Therapeutics; Cambridge (MA); Vor Ort; USD 142.500 - 256.500; Vollzeit

Benefits dieser Stelle

Competitive pay

Comprehensive benefits

In-office collaboration model

Zusammenfassung

Moderna is seeking an Associate Director, Global Regulatory Advertising and Promotion to ensure FDA and global promotional compliance across channels. You will serve as a liaison among Regulatory Affairs, Legal, Medical, and Commercial teams to align regulatory strategy with business goals.

The role requires 5+ years in regulatory affairs with a focus on advertising and promotion, experience with PMRT/MRC, and familiarity with EMA, Health Canada, and UK authorities.

Qualifikationen

• Minimum 5 years of experience in Regulatory Affairs, with at least 2 years focused on advertising and promotion in the pharmaceutical, biotech, or medical device industry.
• Strong knowledge of applicable regulations and enforcement trends.
• Prior experience working with cross-functional review committees in a regulated environment.
• Global regulatory knowledge (EMA, Health Canada, UK etc.) is a plus.

Aufgaben

• Review and approve promotional materials to ensure compliance with FDA and other applicable regulatory requirements.
• Guide promotional strategy as the Regulatory Ad Promo representative during early stages of product development.
• Lead PMRT and MRC discussions with Marketing, Medical, Legal, and Compliance teams to develop compliant promotional material.
• Support interactions with FDA's Advertising and Promotional Labeling Branch (APLB) and other regulatory authorities; prepare regulatory submissions for promotional materials (e.g., 2253 filings).
• Develop and deliver training programs on promotional regulations for internal stakeholders; refine internal SOPs and review processes.
• Monitor enforcement actions and industry trends to mitigate regulatory risks.

Kenntnisse

Regulatory knowledge

Cross-functional collaboration

Global regulatory knowledge

Communications skills

Attention to detail

Ausbildung

Bachelor’s degree in Life Sciences/Regulatory Affairs

Advanced degree (PharmD/JD/Regulatory Affairs)

Jobbeschreibung

Moderna is seeking an Associate Director, Global Regulatory Advertising and Promotion to ensure FDA and global promotional compliance across channels. You will serve as a liaison among Regulatory Affairs, Legal, Medical, and Commercial teams to align regulatory strategy with business goals.

The role requires 5+ years in regulatory affairs with a focus on advertising and promotion, experience with PMRT/MRC, and familiarity with EMA, Health Canada, and UK authorities.