Digital Product Management - Global Head of Digital Regulatory Affairs

Job title : Digital Product Management - Global Head of Digital Regulatory Affairs

Location : Cambridge, MA

About the Job

At Sanofi, we’re committed to providing the next-gen healthcare that patients and customers need. It’s about harnessing data insights and leveraging AI responsibly to search deeper and solve sooner than ever before. Join our Digital Clinical Development Operations Team as lobal Head of Digital Regulatory Affairs and you can help make it happen. Your job? To ensure the success of Sanofi’s Research and Development strategy, Digital Regulatory drives the strategy, delivery, and management of the Digital ecosystem (incl. applications, data foundation, analytics, AI / ML) supporting all aspects of the Global Regulatory Affairs business function’s work.

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?

Main Responsibilities :

They will enable business growth and transformation through best-in-class digital innovation and operational excellence that enable regulators, partners, and internal stakeholders to have meaningful and positive interactions with Sanofi through regulatory information, submissions, and insights.

Working as an extended member of the Global Regulatory Affairs leadership team, they will be a change agent and thought leader on Digital opportunities and priorities.They will also maintain Sanofi’s license-to-operate through scaled, high-quality delivery of Digital capabilities globally.

They will work across the Sanofi enterprise with business teams, other Digital R&D portfolio leaders (e.g. Digital Development, Digital PV), and interface to the global Digital core functions (e.g. Tech, Data / AI, Architecture, etc), as needed.

Unify Regulatory departmental strategy and operational improvement plans into clear, coherent, and value-based digital strategy and roadmap across technologies involved in Regulatory delivery.

Strategically plan and prioritize product roadmaps for all Regulatory digital products (applications, data, models), interfacing to relevant R&D and Digital governance bodies for decisions.

Operationally plan delivery through in-house, outsourced, and co-developed models and through product-aligned, Agile ways of working.

Deliver within allocated budgets and resources and aligned timeframes associated with roadmap delivery.

In collaboration with Global Regulatory Affairs, monitor the global regulatory environment for evolving regulations, data and document standards, and submission tooling, leading Sanofi’s position on innovating to improve outcomes of interaction with Health Authorities.Balance and mitigate risks to maintain steady progression of innovative methodologies.

Monitor the commercial software market for innovations, bringing an advisory point of view to build / buy / partner decisions, including engaging in Digital Strategic Partnering initiatives, as needed.

Be accountable for oversight and quality delivery by digital vendors (software companies, SaaS platform providers, consultancies) working in the Regulatory space.

Foster alignment and adherence to the global data architecture, modernization of data and analytic platforms, as well as the delivery of modern data solutions.

Lead the community of Regulatory Digital practitioners, direct and matrix, accountable for team engagement, talent management, and capability development to keep pace with the rapidly evolving technology landscape.

Engage in Sanofi Digital communities of practice, transformation initiatives, and Extended Leadership Team as a catalyst for change and continuous improvement. ​

About You

A minimum of a bachelor’s degree is required. (A master’s degree in Science, Engineering, or MBA degree preferred).

A minimum of 12 years of industry background and understanding.

Significant industry experience in Regulatory and / or digital product delivery.

Business acumen and demonstrable experiences delivering global scale digital solutions in a pharmaceutical or vaccines R&D setting, preferably with direct experience in Regulatory Affairs (business or digital).

Demonstrable recent experiences with content and data management digital tools, including exposure to data management and AI / ML in R&D.

Direct experience leading teams with demonstrable skills developing people and capabilities in a matrixed, multi-cultural, global organization.

Ability to trave up to 30% overall to Sanofi headquarters and major R&D centers globally.

Fluency in English.(Business fluency in French a plus.)

Diverse experience in different geographical and cultural settings

Seasoned team player with outstanding communication skills, positive attitude, and confident demeanor.

Successful at building a culture of performance and accountability with an orientation to measurable results.

Ability to both “think big” and manage the details to ensure impactful execution

Why Choose Us

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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.

GD-SA ​

LI-SA

LI-Hybrid

DBBUS

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing : a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https : / / www.youtube.com / watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https : / / www.sanofi.com / en / our-responsibility / equality-and-inclusiveness) !

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

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. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https : / / youtu.be / 96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http : / / www.youtube.com / watch?v=SkpDBZ-CJKw&t=2s)