Sanofi Group Global Regulatory Lead GEM in Bridgewater, New Jersey
Global Regulatory Lead GEM
About the Opportunity
Sanofi currently has a great opening for a Global Regulatory Lead to join our Global Regulatory Affairs (GRA) team within the General Medicines and Emerging (GEM) Markets Global Business Unit.
As Global Regulatory Lead you will be the global regulatory lead responsible for new development opportunities and executing the maintenance activities for their assigned products within the GEM portfolio. Additionally, you will act as the global regulatory lead responsible for developing/facilitating product regulatory strategies and presenting to the appropriate governances as applicable.
We are open for the candidate to be based in the USA (Cambridge), the Netherlands (Naarden, moving to Amsterdam at the end of 2018) and in the Czech Republic (Prague).
Lead a portfolio of marketed products for assigned Therapeutic Area (TA) by actively contributing to the development and implementation of regulatory strategies and timelines
Interact with a cross-functional team in the collection, review and assembling of the scientific, clinical, manufacturing and administrative section documents for global submissions to regulatory authorities
Ensure the appropriate peer review of key regulatory documents and submissions across programs in the portfolio
Proactively identifies and communicates to higher management all potential risks and options for issue resolution (e.g. maintenance issues, submissions, etc.)
Research and analyze regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes
Ensure compliance with all internal and external requirements and procedures
While our preference is for someone with a background in Regulatory Affairs, we are open to consider an experienced professional with similar experience (in Medical Affairs, Medical Information, etc) who possesses the skills needed to be successful and has a passion for Regulatory Affairs.
To excel in this role you will need to have:
Bachelor's degree and at least 5 years in Regulatory Affairs or relevant industry experience
Master’s, PharmD, PhD degree and 3 years in Regulatory Affairs or relevant industry experience
Education area of study in a scientific discipline/MS or Doctoral degree/Pharm D a plus.
Demonstrated ability to prioritize multiple projects
Strong multicultural awareness is a must.
Excellent communication and organizational skills as well as attention to detail.
Ability to work in a matrix team environment with strong interpersonal skills (collaborative, tactful and diplomatic).
Motivated, self-starter, and ability to work independently with minimal supervision.
What Sanofi can offer you
A role where you are instrumental to creating best practice and as the organisation grows, you can too.
We offer a generous package including flexible benefits, and are committed to helping you have a healthy work-life balance throughout your career with us.
Empower Life Everyday
At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.
Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we’re not there to try to solve everybody’s problems. We want to focus on those areas where we know we are making a difference.
The values we are live by are teamwork, courage, respect and integrity.
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.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life