Regulatory Affairs Manager – Advertising & Promotion

Sanofi; Morristown (NJ); Híbrido; USD 122.000 - 177.000; Jornada completa

Descripción de la vacante

Sanofi is seeking a Manager Regulatory Affairs Advertising and Promotion to join our team in Cambridge, MA or Morristown, NJ. You will lead regulatory strategies for ads and promotional materials, aligning with brand teams and the global regulatory organization.

The role requires a Bachelor’s degree and 1+ year in pharmaceutical or medical device regulatory affairs, with a proven ability to navigate cross-functional groups and ensure compliant advertising and promotion in the U.S. market.

Formación

• Experience within pharmaceutical or medical device Regulatory Affairs.
• Successful track record with ideally 1-3 years relevant regulatory experience.
• Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.
• Experience in Advertising and Promotion in Regulatory required.

Responsabilidades

• Identifies product-specific or therapeutic area A&P issues and works with other teams to propose and implement solutions.
• Identifies different strategies for addressing issues; advises of risk/benefit of each and assists clients with making sound business decisions with the understanding of the potential risk/benefits with respect to intervening regulatory matters.
• Oversees and bears responsibility for the successful implementation of regulatory strategic objectives and projects with minimal supervision.
• Active participant and Regulatory representative on brand teams and Review Committees (RC) for commercial and medical materials, respectively.
• Provides guidance and feedback to internal Sanofi constituencies (commercial groups, R&D) to maximize the competitive impact of product development as well as ultimate promotion, advertising, and reimbursement.
• Provides input to the Global organization on domestic regulatory strategies for in-line products through life cycle management programs.
• Contribute A&P expertise to the development of optimal labeling on new and supplemental new drug applications.
• Provides product-specific Regulatory strategies to mitigate risk; works in conjunction with brand team management to provide advice and risk/benefit analysis to maximize value to stakeholders.
• Performs other duties as assigned.

Conocimientos

Pharma regulatory affairs

Cross-functional collaboration

Advertising & Promotion

Regulatory strategy

Educación

Bachelor’s degree

Descripción del empleo

Sanofi is seeking a Manager Regulatory Affairs Advertising and Promotion to join our team in Cambridge, MA or Morristown, NJ. You will lead regulatory strategies for ads and promotional materials, aligning with brand teams and the global regulatory organization.

The role requires a Bachelor’s degree and 1+ year in pharmaceutical or medical device regulatory affairs, with a proven ability to navigate cross-functional groups and ensure compliant advertising and promotion in the U.S. market.