Regulatory Affairs Innovation Lead - VIE Contract

Regulatory Affairs Innovation Lead - VIE Contract

• Location: USA, Cambridge
• Target start date: 01/12/2025

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address.

About the job

As Regulatory Affairs Innovation Lead VIE within our Global Regulatory Operations team, you’ll be at the forefront of transforming how we approach regulatory strategy and operations.

In this role, you'll work on the innovation funnel for discovery and validation of innovative ideas, solving tomorrow's problems today and making ideas from good to great.

You will be a key catalyst for change, collaborating closely with Digital teams, R&D Data Office, Business Process Owners, Capabilities Leads, and other key stakeholders to identify breakthrough opportunities and drive transformational initiatives. Your work will directly impact our ability to bring life-changing treatments to patients faster and more efficiently.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible.

Ready to get started?

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main responsibilities:

• Analyze current GRA processes to identify inefficiencies and opportunities for automation or digitization, and design and implement process improvements that enhance quality, reduce timelines, and increase operational efficiency.
• Support the adoption of digital tools, AI/ML applications, and data analytics within regulatory operations.
• Support data standardization and management initiatives to improve decision-making and regulatory intelligence and collaborate with data science teams to develop predictive analytics and insights for regulatory planning.
• Partner with GRA leadership to communicate innovation strategy and secure buy-in for transformational initiatives.
• Build relationships with external innovation partners, vendors, and regulatory authorities to stay informed of industry trends, and present innovation updates and results to senior leadership and cross-functional teams.
• Establish and maintain innovation frameworks, methodologies, and governance structures and document and share lessons learned, best practices, and success stories across the GRA organization.

About you

Experience:

• Minimum 1 year of full-time work experience in regulatory affairs, life sciences consulting, process improvement, digital transformation, or innovation management within the pharmaceutical/biotech industry.
• Experience with project management methodologies (Agile, Lean, Six Sigma) and change management principles and/or familiarity with Innovation Portfolio Management processes, Strategyzer innovation methodology, Design Thinking principles, and Strategic Foresight techniques would be a strong advantage.
• Familiarity with regulatory processes, submissions, and health authority interactions is preferred.
• Experience with digital tools, data analytics, or emerging technologies in regulatory context is a plus.

Soft and technical skills:

• Strong communication and presentation skills with ability to influence stakeholders at all levels.
• Entrepreneurial mindset with comfort in ambiguous, fast-paced innovation environments and in global, diverse teams.
• Excellent project management skills with ability to manage multiple innovation initiatives simultaneously, ability to think strategically while executing tactically with attention to detail.
• Strong analytical and problem-solving abilities and advanced critical thinking skills with a systematic approach to innovation funnel management.

Education:

• Master's Degree in Life Sciences, Engineering, Business Administration, or related field (degree in Regulatory Science, Digital Health, or Innovation Management is advantageous).

Languages:

• Excellent proficiency in English is mandatory.
• Additional languages would be an asset (French, Italian or other).

Why choose us?

iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow. 

• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.
• Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to spark new ideas and drive breakthroughs.
• Accelerate your professional development with structured career paths designed for both scientific and leadership advancement. Grow in ways you never imagined through bold moves that stretch your potential, cross moves into other business areas, and short-term gigs that build your scientific expertise.
• Join a workplace where diversity, equity, and inclusion are at the core, with Employee Resource Groups and leadership programs that celebrate every voice.
• Achieve genuine work-life balance in a supportive R&D environment.
• Enjoy outstanding benefits, including flexible working options, comprehensive healthcare, and well-being programs designed to help you thrive.

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