Sanofi Group Senior Manager, Regulatory Affairs, Advertising and Promotion in Cambridge, Massachusetts
Under the direction of the Senior Director, this individual will be responsible for providing US regulatory review and approval of promotional and other product and disease-related materials for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio. 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.
This position can be located in Cambridge, MA or Bridgewater, NJ. Completely remote working arrangement can also be considered.
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, 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:
Bachelor’s degree from an accredited four-year college or university (Area of specialization: Life Sciences)
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 Senior 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
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.