Head of Regulatory Affairs Master Data Management, Security, Interfaces, and Business Data Model

Job Title: Head of Regulatory Affairs Master Data Management, Security, Interfaces, and Business Data Model

Location: Cambridge, MA Morristown, NJ

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

Join our Regulatory Data, Digital and AI team as Head of Regulatory Affairs Master Data Management and you’ll drive transformative change by developing and executing master data strategies that ensure regulatory compliance and optimize data architecture and data interoperability across internal and external systems. The role encompasses oversight of interfaces, connectors, conceptual and logical data models, master data life-cycle management, and security within our Regulatory Affairs Technology Stack. A critical aspect of this role is fostering integration and collaboration across R&D Data Office, Digital, Research & Development (R&D), Manufacturing & Supply (M&S), and Commercial divisions to enhance organizational synergy and efficiency, promoting Sanofi's vision to influence standards and technology evolutions.

Additionally, this role requires a shift in mindset towards a data coding approach, focusing on transitioning from traditional terminologies to data keys and their interoperability across regions. This change will empower teams to leverage data more effectively, drive innovation, and enhance consistency and data quality within and between applications.

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:

• Strategic Leadership:Develop and implement a forward-thinking master data strategy that aligns with Sanofi's regulatory and business objectives, ensuring compliance and operational excellence.

• Cross-Functional Collaboration:Foster strong partnerships with Digital, R&D, M&S, and Commercial teams to ensure cohesive integration of master data management strategies across all business units and ensure robust data governance within Regulatory Affairs.

• Digital and AI Integration: Drive the adoption of digital technologies and AI solutions within regulatory affairs to enhance efficiency and compliance.

• Change Management: Lead organizational change initiatives, particularly in digital transformation, to drive innovation and adaptability within the regulatory landscape.

• Regulatory Expertise: Ensure all data management practices meet global regulatory requirements and support business goals while respecting Sanofi's intellectual property security policy.

• Data Flow Management: Oversee the documentation and management of data flows, both upstream and downstream, in relation to Vault RIM. Ensure seamless data integration, interoperability, and compliance across systems to enhance regulatory operations and decision-making.

About You

• Experience: Proven track record of leadership in the pharmaceutical or biotechnology industry, with deep expertise in regulatory affairs and data management. Demonstrated ability to drive strategic initiatives, foster cross-functional collaboration, and implement effective data governance practices.

• Technical Skills:Deep understanding of global regulatory requirements, data governance principles, system validation, data security, and emerging technologies such as AI and machine learning.

• Leadership Abilities: Proven capability to lead global, cross-functional teams; strong strategic thinking; excellent communication skills; and experience in change management.

• Collaborative Expertise: Demonstrated ability to foster cross-functional collaboration, particularly between R&D, M&S, and Commercial divisions, to drive integrated data management solutions.

• Track Record: Proven history of leading successful initiatives in master data management within a regulatory context, showcasing measurable compliance and operational efficiency improvements.

• Impact: Your leadership will be pivotal in navigating the complexities of regulatory compliance and digital transformation. Establishing robust data management practices and fostering cross-functional collaboration will enable Sanofi to make informed decisions, accelerate regulatory submissions, and bring life-changing therapies to patients more efficiently.

• Education: Advanced degree (Master's or PhD) in Regulatory Affairs, Information Management, Computer Science, Life Sciences, or a related field.

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-Onsite
 #vhd