Position Overview:

With minimal direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches. As the product AP expert, contribute to the development and implementation of regulatory strategies for labeling, product defense, and development projects. Serve as the primary liaison with FDA, for assigned products, on matters related to advertising and promotional compliance matters.

Key Responsibilities:

Identifies product specific or therapeutic area AP 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, RD) 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.

Responsible for assigning material type codes on FDA Form 2253 as appropriate, relevant comments, submission review and finalization.

Contribute AP 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.

Basic Qualifications:

Bachelor’s degree in Life Sciences from an accredited four-year college or university.Work Experience Required:

1-3 Years experience in the following areas:

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.

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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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