Regulatory Affairs Leader, Advertising & Promotion

Teva; West Chester (Chester County); On-site; USD 140,000 - 175,000; Full time

Benefits offered by this job

Generous annual leave

Bonus plans

Flexible working schedules

Tailored health support

Community involvement initiatives

Job summary

Teva, a leading biopharmaceutical company, seeks an Associate Director of Regulatory Affairs for Advertising and Promotion to lead regulatory reviews of promotional materials and drive compliance. You will chair PARC meetings, coordinate with Medical Affairs, Legal, and Compliance, and manage FDA 2253 submissions for multiple products.

This role reports to the Senior Director and supports pipeline and marketed products, shaping promotional strategy and handling enforcement trends while guiding

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree (PharmD, MS, PhD) a plus.
• 4+ years in pharmaceutical/biotech regulatory affairs, with at least 2 years in Advertising and Promotion.
• Experience across multiple promotional channels including HCP materials, DTC, digital and payer communications.

Responsibilities

• Lead regulatory review of promotional and educational materials for assigned products across channels.
• Chair PARC review meetings, assess substantiation, fair balance, and indication accuracy.
• Collaborate with Medical Affairs, Legal, and Compliance on promotional activities and regulatory strategy.
• Oversee Form FDA 2253 submissions and serve as regulatory contact for OPDP correspondence.
• Help develop and maintain review standards, templates, and precedent documentation.

Skills

Regulatory affairs

OPDP enforcement

FDA submissions

Cross-functional collaboration

Promotional materials review

Education

Bachelor's in life sciences

Tools

Veeva Vault PromoMats

Zinc MAPS

Job description

Teva, a leading biopharmaceutical company, seeks an Associate Director of Regulatory Affairs for Advertising and Promotion to lead regulatory reviews of promotional materials and drive compliance. You will chair PARC meetings, coordinate with Medical Affairs, Legal, and Compliance, and manage FDA 2253 submissions for multiple products.

This role reports to the Senior Director and supports pipeline and marketed products, shaping promotional strategy and handling enforcement trends while guiding