Senior Director, Regulatory Affairs — Ad/Promo & Labeling

SK Life Science; Paramus (NJ); On-site; USD 180,000 - 230,000; Full time

Job summary

SK Life Science is seeking a Senior Director of Regulatory Affairs, Advertising, Promotion and Labeling in Paramus, NJ. The role leads regulatory strategy for promotional materials and labeling, working to ensure compliance with US FDA, EMA and global regulations.

You will oversee PRC/MSRC activities, guide cross-functional teams, and manage labeling development for CCDS and USPI while coordinating with Global Regulatory Leads. Strong leadership and communication essential.

Qualifications

• BS or MS with requisite experience and demonstrated capability; advanced degree preferred.
• 10+ years in regulatory pharmaceutical industry with extensive experience in advertising and promotion regulatory affairs including PMRC participation.

Responsibilities

• Serve as Regulatory Lead and primary regulatory approver for PRC and MSRC for assigned products.
• Provide strategic regulatory guidance on development of promotional, advertising, and educational materials to ensure fair balance with USPI.
• Lead interactions with FDA OPDP and APLB including pre-submission advisory comments and responses to enforcement letters.
• Oversee preparation and timely submission of all approved promotional materials to FDA on Form FDA 2253 and other submissions.
• Monitor regulatory landscape and advise leadership on risk mitigation.

Skills

Regulatory affairs

Advertising & Promotion

Leadership

English fluency

Veeva PromoMats

Communication skills

Education

BS/MS in relevant field

Advanced degree (MD/PhD/PharmD) preferred

Tools

Veeva PromoMats

Job description

SK Life Science is seeking a Senior Director of Regulatory Affairs, Advertising, Promotion and Labeling in Paramus, NJ. The role leads regulatory strategy for promotional materials and labeling, working to ensure compliance with US FDA, EMA and global regulations.

You will oversee PRC/MSRC activities, guide cross-functional teams, and manage labeling development for CCDS and USPI while coordinating with Global Regulatory Leads. Strong leadership and communication essential.