Director, Regulatory Advertising & Promo

328051BR
USA

Job Description

769 million patients were impacted by Novartis products in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

The Director Regulatory Advertising & Promo is responsible for strategic leadership of regulatory reviews and guidance relating to promotional activities for assigned products/Franchise.

Your responsibilities will include:

•Serves as a regulatory reviewer for assigned products/Franchise. Ensures regulatory compliance while effectively managing business risks.
• Directs the activities of regulatory personnel responsible for submissions of promotional materials to FDA.
• Provides strategic regulatory advice and guidance as a member of the Franchise Governance Board.
• Ensures that strategic regulatory subject matter expertise is provided on advertising and promotion materials/activities for Franchise products in accordance with business goals and objectives, FDA regulations/guidances, PhRMA guidelines and company policy.
• Reviews relevant medical and clinical development non-promotional materials in accordance with company policies.
• Engages in onboarding new hires, junior colleagues, fellows and interns within the Reg A&P group and may offer training/mentoring/coaching to these individuals.
• Represents Reg A&P on internal, cross-functional, cross divisional initiatives relevant to promotion of prescription products in the US.
• Primary liaison with Office of Prescription Drug Promotion (OPDP) regarding advertising and promotion for Franchise products, including authoring submissions for Requests For Advisory Comments, responses to OPDP letters and complaint letters to OPDP.

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
PHARMA
US PHARMA
USA
East Hanover, NJ
Research & Development
Full Time
Regular
No
careers default image
328051BR

Director, Regulatory Advertising & Promo

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