Senior Manager Regulatory Affairs Advertising and Promotion

Main Responsibilities

• 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.

About You

Basic Education Qualifications: Bachelor’s degree from an accredited four-year college or university; Science focus preferred but not required.

Work Experience Required: 3+ Years experience in the within pharmaceutical or medical device advertising and promotional review. Successful track record with ideally 1-3 years relevant regulatory experience. Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.

Knowledge, Skills and Equivalent Experience

• Knowledge and understanding of complex medical and scientific subject matter.
• Ability to work well within cross-functional teams.
• Demonstrates solid oral communication and writing skills.
• Understanding of the U.S. pharmaceutical marketplace, and familiarity with medical terminology.
• Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
• Develops collaborative relationships to facilitate the accomplishment of work goals.
• Develops and proposes innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.
• Shows ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans.
• Can build collaborative internal networks to obtain cooperation.
• Unquestionable ethics, professional integrity and personal values consistent with the Sanofi values.
• Is able to balance projects with day-to-day duties, ensuring participation from other members of the department as needed.
• Is able to establish priorities and timelines to effectively manage workload.
• Is able to multi-task well.
• Deals with people in an honest and forthright manner representing information and data accurately.