Senior Director, Regulatory Advertising & Promotions

Tris Pharma; South Brunswick (NJ); Hybride; USD 160 000 - 230 000; Plein temps

Avantages offerts par ce poste

Bonus eligible

Medical insurance

Dental insurance

Vision insurance

401K with match

Paid holidays

PTO

Volunteer time

Employee resource groups

Résumé du poste

Tris Pharma, Inc. in Monmouth Junction, NJ, invites applications for an Associate Director or Director, Advertising & Promotions to oversee regulatory review of promotional materials.

The role reports to the Head of Regulatory Affairs Advertising and Promotion and supports compliant business execution. The incumbent provides strategic regulatory guidance, manages FDA submission requirements, and leads reviews to ensure accuracy, balance, and FDA compliance.

Qualifications

• PhD or PharmD in life sciences with 3+ years of regulatory review experience
• Bachelor's degree in life sciences with 7+ years of regulatory review experience
• Direct FDA interaction experience required
• In-depth knowledge of FDA regulations and interpretation for prescription drug advertising, promotion, and labeling required

Responsabilités

• Reviews and approves advertising and promotional materials for FDA compliance
• Provides strategic regulatory input for compliant yet competitive advertising
• Serves as regulatory advisor on promotional initiatives across the company
• Maintains awareness of new FDA regulations and communicates to management
• Prepares and approves FDA-2253 submissions to OPDP
• Drives process improvements in Advertising and Promotion regulatory areas

Connaissances

Regulatory affairs

FDA knowledge

Stakeholder influence

Regulatory submissions

Formation

PhD or PharmD in life sciences

Bachelor's degree in life sciences

Description du poste

Tris Pharma, Inc. in Monmouth Junction, NJ, invites applications for an Associate Director or Director, Advertising & Promotions to oversee regulatory review of promotional materials.

The role reports to the Head of Regulatory Affairs Advertising and Promotion and supports compliant business execution. The incumbent provides strategic regulatory guidance, manages FDA submission requirements, and leads reviews to ensure accuracy, balance, and FDA compliance.