US Regulatory Advertising & Promotion Manager

Viatris; Washington (District of Columbia); On-site; USD 120,000 - 160,000; Full time

Job summary

Viatris seeks a Manager Advertising and Promotion Regulatory Affairs to lead US regulatory strategy for promotional materials and labeling, ensuring compliance with FDA rules. You will coordinate with cross-functional teams including Commercial and Clinical Affairs, and serve as the regulatory liaison with the FDA on PRC matters.

The role requires familiarity with DDMAC/OPDP processes, lifecycle management input, and proactive risk assessment to support commercial growth while safeguarding

Qualifications

• Bachelor's degree and 2–4 years of experience; BS in Pharmacy or Nursing with 5 years A/P RA or 5–7 years cross-functional regulatory experience preferred.
• Knowledge of US pharmaceutical marketplace and medical terminology required.
• Experience supporting regulatory review of promotional materials and interactions with DDMAC or OPDP.
• Ability to balance projects with day-to-day duties and manage priorities.

Responsibilities

• Provide US regulatory expertise for FDA advertising, promotion, and labeling activities for Viatris' sales and marketing initiatives.
• Oversee implementation of regulatory objectives and review proposed marketing plans and actions.
• Offer regulatory leadership to Commercial, Clinical Affairs, and other functions to maximize product promotion value.
• Provide input to global organization on domestic regulatory strategies and lifecycle management.
• Coordinate, review, and follow up on regulatory submissions related to advertising and promotion.
• Build Relationship Management with FDA; coordinate with agency contacts and PRC committee.
• Provide Regulatory training for Marketing, Clinical Affairs, Sales, and other functions.
• Stay current on FDA regulations and guidance related to advertising and regulatory applications.

Skills

FDA advertising compliance

Regulatory affairs

Cross-functional collaboration

Medical terminology

Regulatory strategy

Education

Bachelor's degree in Pharmacy or Nursing

Tools

Regulatory submissions management

Job description

Viatris seeks a Manager Advertising and Promotion Regulatory Affairs to lead US regulatory strategy for promotional materials and labeling, ensuring compliance with FDA rules. You will coordinate with cross-functional teams including Commercial and Clinical Affairs, and serve as the regulatory liaison with the FDA on PRC matters.

The role requires familiarity with DDMAC/OPDP processes, lifecycle management input, and proactive risk assessment to support commercial growth while safeguarding