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Senior Manager, US Advertising and Promotion, Global Regulatory Affairs

Bridgewater, NJ;Swiftwater, PA

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our Sanofi Pasteur Swiftwater, PA site, where we both research and manufacture vaccines since 1897, has had a tremendous impact on global health and the quality of human life. Nestled among the Pocono Mountains in Swiftwater, Pennsylvania, Sanofi Pasteur is home to state-of-the-industry facilities—and a rich and unique history. Our Swiftwater campus is more than 500 acres, housing 44 buildings and encompassing more than one million square feet of building space. Many of our facilities, while bright and modern, still retain the rustic charm of the original stonework.

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  • PAID TIME OFF

    Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!

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Responsibilities

Job overview

Under the direction of the Director, this individual will be responsible for providing US regulatory review and approval of promotional and other product and disease-related materials within the Medical Affairs and Commercial Operations groups.  As the product expert, this individual helps to develop and implement regulatory strategies related to promotion and advertising campaigns, promotional labeling, product defense and development projects. Provides input into GRA Labeling organization for labeling strategies impacting the Advertising and Promotion of investigational and marketed products.  Liaises with the Office of Prescription Drug Promotion (OPDP) and/or the Advertising and Promotional Labeling Branch (APLB) of the FDA.

Responsibilities

  • Represent GRA (US AdPromo) as a member of cross-functional brand and portfolio team review committees (RC), providing regulatory input into the review and approval of advertising, promotion, disease-state, medical, market access, and press materials. Submit materials on form FDA 2253 when applicable. 
  • Provides US AdPromo strategies and opinions for investigational and marketing products to mitigate risk, provide advice and give risk/benefit analysis to meet both short- and long-term growth targets. Consults with senior management and provides input to the Global organization when necessary. 
  • Contribute AdPromo expertise to the development of optimal FDA labeling on original and supplemental New Drug Applications and/or Biologics License Applications. 
  • Primary Liaison with OPDP/APLB and effectively manages relationships with FDA contacts; establishes and maintains strong collaborative relationships with Regulatory and other R&D colleagues, as well as other functions (e.g., Legal, Medical, Marketing, Communications and Compliance)
  • Participate in the development, monitoring and updating of standards and processes related to drug, device, and biologics AdPromo regulations and guidance’s.

Requirements & Qualifications

Educational Background:

Bachelor’s degree from an accredited four-year college or university (Area of specialization: Life Sciences)

Job-Related Experience:

1-5 Years

  • Experience within pharmaceutical and/or medical device Regulatory Affairs
  • Successful track record with ideally 1-5 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.
  • Can demonstrate solid oral communication and writing skills.
  • Understanding of the U.S. pharmaceutical market place, 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 solutions.
  • Develops collaborative relationships to facilitate the accomplishment of work goals.
  • In conjunction with the Director, generates 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 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

Terms of employment

This is a desk job using standard office equipment with no specific physical requirements.

What makes this position unique?

The regulatory AdPromo space is a niche area of expertise, with a narrow pool of candidates.  Moreover, the US regulatory environment has been undergoing significant changes in terms of FDA regulation on AdPromo and other manufacturer communications.  Our AdPromo group lives in two distinct parts of the Sanofi group, being part of the GRA organization in R&D while also having a clear business-facing role.

Benefits of working in this role

  • New and exciting opportunity to become part of a dynamic multidisciplinary team working together to review and approve vaccine-associated disease awareness and promotional materials for the marketplace. 
  • Participate as the recognized regulatory lead in the important post-approval efforts to support public health as new vaccines are developed and marketed.

Location information

This position can be located in Swiftwater, PA or Bridgewater, NJ.  If located in Bridgewater, NJ, this individual would be expected to travel to Swiftwater, PA at most once/week.  

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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