Director, Advertising & Promotions Regulatory Affairs

Tris Pharma, Inc.; New Jersey; Hybrid; USD 160,000 - 230,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Rx insurance

401K with match

Life insurance

Paid holidays

PTO

Volunteer time off

Employee Resource Groups

Job summary

Tris Pharma, Inc. is seeking an experienced Associate Director or Director in our Regulatory Affairs team in Monmouth Junction, NJ, to lead advertising and promotion oversight.

The role requires senior regulatory expertise to ensure promotional materials comply with FDA labeling and guidance while aligning with business goals. The incumbent will review materials, provide strategic regulatory input, interact with the FDA OPDP, and lead submission processes.

Qualifications

• In-depth knowledge of FDA regulations and their interpretation required.
• Direct experience interacting with FDA OPDP required.
• Ability to influence without direct authority required.

Responsibilities

• Reviews and approves advertising and promotional materials for regulatory compliance.
• Provides strategic regulatory input to develop compliant yet competitive promotions.
• Serves as regulatory advisor for promotional initiatives across the company.
• Keeps current with FDA rules, guidance, and enforcement actions affecting advertising and labeling.
• Delivers training on FDA expectations for advertising and promotion.
• Prepares Form FDA-2253 submissions to OPDP.
• Drives improvements in regulatory review processes for advertising and promotion.

Skills

FDA regulations

FDA interactions

Influence without authority

Education

PhD or PharmD

Bachelor's degree with experience

Job description

Tris Pharma, Inc. is seeking an experienced Associate Director or Director in our Regulatory Affairs team in Monmouth Junction, NJ, to lead advertising and promotion oversight.

The role requires senior regulatory expertise to ensure promotional materials comply with FDA labeling and guidance while aligning with business goals. The incumbent will review materials, provide strategic regulatory input, interact with the FDA OPDP, and lead submission processes.