Senior Director, Regulatory Affairs (Ad Promo)

Bausch Health Companies Inc.; New York (NY); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics Senior Director of Advertising & Promotion in Regulatory Affairs oversees regulatory review of promotional materials for prescription, OTC, and cosmetic products in the US, with Canada support. You will manage review teams, ensure FDA compliance, and provide strategic guidance on claims.

The role requires a strong background in pharma regulatory affairs, with 10+ years of experience, a bachelor's in a science/health field, and advanced degrees preferred.

Qualifications

• Bachelor's in science or health-related field required.
• 10+ years in pharmaceutical regulatory affairs focused on advertising and promotion.
• Advanced degrees (PhD, MD, MS, PharmD) preferred.
• Experience with FDA, OPDP, and PAAB regulations.

Responsibilities

• Manage regulatory promotional review teams.
• Ensure adherence to FDA and Canadian regulations.
• Provide strategic guidance on claims.
• Monitor industry regulatory trends.
• Handle escalations and discussions with authorities.
• Conduct regulatory training.
• Collaborate with Legal, Compliance, Medical Affairs, and Quality departments.

Skills

FDA/OPDP/PAAB regs

Education

Bachelor's in science or health-related field

Advanced degrees preferred (PhD/MD/MS/PharmD)

Job description

Role: Senior Director of Advertising & Promotion - Regulatory Affairs

Overseeing regulatory compliance for promotional materials of prescription, OTC, and cosmetic products primarily in the US, supporting Canada.

Responsibilities

• manage regulatory promotional review teams
• ensure adherence to FDA and Canadian regulations
• provide strategic guidance on claims
• monitor industry regulatory trends
• handle escalations and discussions with authorities
• and conduct regulatory training.
• Collaborate with Legal, Compliance, Medical Affairs, and Quality departments.

Qualifications

• Bachelor's in science or health-related field
• 10+ years in pharmaceutical regulatory affairs focused on advertising and promotion
• advanced degrees (PhD, MD, MS, PharmD) preferred
• strong industry knowledge, interpersonal skills, and experience with FDA, OPDP, and PAAB regulations.

HighValue: experience in pharma advertising regulation, FDA/Canada compliance, cross-functional collaboration, and leadership in a complex regulatory environment.

Work Setup

multiple US locations, no specific travel details provided.