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Sanofi Group Manager, US Regulatory Affairs in Bridgewater, New Jersey

Under the direction of their supervisor, this individual will be responsible for managing US regulatory support for marketed products, contributing US Regulatory strategies as a member of applicable Global Regulatory Teams.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

  • Contributes to the development and oversees the successful implementation of regulatory strategies for assigned products and/or projects, including submission and maintenance activities related to NDAs, such as annual reports, safety reports, and labeling.

  • Leads and/or participates on multi-disciplinary matrixed project teams that work to project deadlines while adhering to regulatory requirements for products and/or projects.

  • Consults with management to develop and communicate robust product-specific regulatory strategies to mitigate risk; works in conjunction with brand team management and GRTL to provide advice and risk/benefit analysis to maximize value to stakeholders.

  • Serves as primary contact with FDA, manages FDA relationships ensuring communications are documented; establishes and maintains strong collaborative relationships with GRA and other R&D colleagues, as well as other functions (e.g., Legal, Medical, Marketing, Compliance).

  • Manages and participates in the development, monitoring and updating of standards and processes related to drug, device, and biologics regulations.

  • Performs other duties as assigned.

REQUIRED EDUCATIONAL BACKGROUND AND JOB-RELATED EXPERIENCE:

  • 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 solution.

  • Develops collaborative relationships to facilitate the accomplishment of work goals.

  • In conjunction with their supervisor, 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-aventis 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.

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health.This position will require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

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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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.

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