Director Dermatology Ad Promotions & Compliance

Organon; Harmonville (PA); On-site; USD 152,000 - 259,000; Full time

Job summary

Organon is seeking a Senior Regulatory Affairs professional to oversee day-to-day review and approval of US Dermatology promotional materials. You will ensure materials are accurate, balanced, and supported by current evidence, while coordinating with FDA on advertising issues.

You will drive regulatory strategy with cross-functional teams, participate in labeling and product development meetings, and mentor staff.

Qualifications

• Bachelor's degree in life science or equivalent; advanced degree preferred.
• Experience in dermatology is preferred.
• Minimum 7 years’ pharmaceutical experience with advertising/promo.
• Strong understanding of regulatory advertising and promotion regulations.
• Excellent negotiation and communication skills; able to work with senior leadership.
• Experience interacting with the FDA.

Responsibilities

• Review and approve day-to-day US Dermatology promotional materials.
• Ensure materials are accurate, truthful, and not misleading per labeling and evidence.
• Serve as liaison with FDA on advertising/promotional issues.
• Communicate regulatory risks to Senior Marketing, PRC, Global Regulatory, Medical Affairs.
• Drive regulatory strategy in collaboration with Commercial, PRC, Global Regulatory Liaisons.
• Participate in labeling and product development meetings.
• Develop and implement departmental strategic initiatives; advise leadership on risk.
• Improve regulatory environment through agency contacts and associations.
• Foster cross-organizational collaboration across review committees.
• Provide regulatory training to team members.

Skills

Regulatory advertising

Negotiation

Communication skills

Leadership collaboration

FDA interactions

Dermatology experience

Education

Bachelor’s degree in life science

Advanced degree preferred

Job description

Organon is seeking a Senior Regulatory Affairs professional to oversee day-to-day review and approval of US Dermatology promotional materials. You will ensure materials are accurate, balanced, and supported by current evidence, while coordinating with FDA on advertising issues.

You will drive regulatory strategy with cross-functional teams, participate in labeling and product development meetings, and mentor staff.