Associate Director, Regulatory Affairs
Swiftwater, Pennsylvania, Meriden, Connecticut
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Sanofi is recruiting for an Associate Director, Regulatory Affairs to lead the US regulatory activities in support of our mRNA vaccine portfolio. The preferred location is one of the following US sites Meriden (CT), Bridgewater (NJ), Swiftwater (PA), or Cambridge (MA) however flexible arrangements can be discussed.
At Sanofi, we believe in a world in which no one suffers or dies from vaccine-preventable diseases. And while the pandemic has shaken up our industry, creating new opportunities and risks, we believe the acceleration of innovation with mRNA technology means vaccines for more people faster than before. That’s why we’re looking for bold, optimistic world-changers to support our mRNA Center of Excellence.
A robust regulatory strategy is critical for the success of the business and has a direct impact on time to market access. The Associate Director, Regulatory Affairs will work in close collaboration with the Global Regulatory Team as well as cross-functional teams to provide oversight and management of our vaccine development programs with a focus on the continued growth of Sanofi’s mRNA vaccines from development through licensure.
Responsible for the development and implementation of US regulatory strategy
Lead and facilitate cross functional activities related to US strategy by participating in Global Regulatory Teams as well as product related teams
Serve as the primary point of contact with US FDA on matters related to assigned products
Within the context of global strategy, determine appropriate timing of US strategy and US FDA interactions in line with the product plan
Lead and participate in meetings with US regulatory agencies as appropriate
Ensure that responses to FDA questions are handled in a timely manner and in line with the approved product strategy
Lead and execute key regulatory activities, including planning, authoring, gathering, and review of documents necessary to support regulatory submissions. This may include but is not limited to new IND and BLA submissions, formal meeting requests, briefing packages, and responses to queries from regulatory agencies concerning clinical development.
Identify and mitigate risks that impact submission timelines
Maintain working knowledge of laws, guidances, and requirements related to biologics/vaccines in addition to general regulatory knowledge
A minimum of a Bachelor’s degree in a scientific or medical field of study
An advanced degree (e.g. M.S., Ph.D., PharmD) is preferred
Minimum of 5 years of experience working in a regulatory affairs function preferred
Thorough knowledge of the vaccine development process and eCTD submissions
An understanding of product lifecycle from discovery to clinical trials to marketing is preferred
Previous experience interacting with health authorities
Flexible, detail-oriented, and willingness to work in a dynamic and fast-paced environment while managing multiple priorities
Ability to work independently, within a group setting, and interact effectively across cross-functional departments
Strong communication skills (oral, written, and interpersonal)
Critical-thinking and ability to identify and recommend solutions to problems
Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
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.
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.
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