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Digital Regulatory Information Management Lead

Synthorx

Synthorx

IT, Legal
Multiple locations
Posted on Wednesday, November 29, 2023

Digital Regulatory Information Management Lead

Location: Bridgewater, NJ

Remote Work: Hybrid model

Travel Expected: 10% - 20%

Job Type: Full time

About the Job

At Sanofi Consumer Healthcare, we have one shared mission – we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come.

In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view.

Everything we do is centered around people’s interests – our consumers, our customers, healthcare professionals, and our employees – across the world.

We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu.

We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best.

Our Team

As the CHC Health and Science Global function within the Digital Division, our mission is clear: we are dedicated to revolutionizing healthcare. We act as strategic partners, providing an organization-wide perspective while effectively utilizing available resources. Our primary focus is on enhancing information systems and refining core competencies in R&D, Regulatory, Sustainability & packaging, Medical, and Development, all to maximize value for our consumers. Our unwavering commitment to consumer-centric transformation is central to our mission, driving us to improve lives and instigate significant change. By seamlessly merging scientific expertise with consumer insights, we're reshaping our approach to research, development, and the delivery of science-driven solutions that positively impact global health. Our dedication to consumer-centric transformation empowers individuals to actively engage in their healthcare journey and fosters a culture of collaboration, co-creation, and the pursuit of ground-breaking scientific achievements through partnerships with consumers.

As the Digital Regulatory Information Management Lead, you will assume a crucial role in orchestrating the implementation and support of digital solutions and information management systems, essential for facilitating effective regulatory compliance and information flow. This position will require strong strategic leadership, team management, and collaborative efforts with various departments to enhance regulatory processes and data management. This role will oversee selection of a Global RIM platform Fit for CHC business.

In your capacity as the Digital Regulatory Information Management Lead, you will act as the primary point of contact for business stakeholders in the realm of regulatory information management, with the objective of optimizing the value derived from digital investments and technology partnerships. This role necessitates a comprehensive grasp of regulatory frameworks and compliance requirements. It is a highly integrated position, underscoring your ability to influence, negotiate, plan, and oversee projects to drive alignment and performance across the organization.

Success in this role will be contingent upon your enthusiasm, meticulous attention to detail, and unwavering dedication to advancing regulatory information management to meet industry standards and contribute to the organization's overall success.

Main Responsibilities

  • RIM Strategy: responsible for partnering with internal and external stakeholders in executing the RIM strategy and vision for the organization. This includes activities related to RIM Platform, planning and budgeting (in partnership with Science- Regulatory affairs), for key systems implementation/roadmap, analysis of current submission and registration information processes, and preparing a business case for Change.

  • Regulatory Compliance: Ensure that all digital solutions and systems align with local and international regulatory standards in the consumer healthcare sector. The role has primary responsibility in RIM Digital Platform and Data Management Standards, Data Governance & supporting business Operations.

  • Information Management: Develop and execute Digital platform strategies for effective management of regulatory information, including product submissions, approvals, and compliance documentation.

  • Digital Transformation: Drive the digital transformation agenda within regulatory affairs, leveraging technology to streamline processes, enhance data analytics, and improve decision-making. A key responsibility of this role is to identify and recommend improvements to business processes, regulatory data, and data definitions for the RIM platform, while working in close collaboration with Global Science- Regulatory affairs leadership & teams (and cross-functional stakeholders (e.g., Clinical, Nonclinical, Quality etc)

  • Team Leadership: Build and lead a high-performing team of digital and regulatory experts (both internal & external), fostering a culture of innovation and continuous improvement.

  • Stakeholder Collaboration: Collaborate with cross-functional teams, including regulatory affairs, quality assurance, and product development, to ensure alignment and seamless integration of digital solutions.

  • Vendor Management: Oversee relationships with technology vendors and service providers, ensuring the delivery of high-quality solutions and services.

  • Risk Management: Identify and mitigate digital and regulatory risks, proactively addressing issues that may impact compliance or operations.

  • Platform management: Lead implementation/ maintenance, and governance of E2E RIM program: plan, configure and manage E2E RIM implementation. Ensure users requirements are adequately documented and serve as the basis for system continuous improvement, reengineering, and/or new system selection.

  • Budget Oversight: Manage the budget for digital initiatives within regulatory information management, optimising resources for maximum impact.

About You

Experience

  • Proven experience (8+ years) in regulatory information management.

  • Life sciences and/or consumer healthcare industry.

  • Strong knowledge of regulatory compliance requirements and best practices.

  • Experience in digital transformation projects, including in systems management or implementation in the life sciences industry or regulated industry.

  • Excellent leadership and team management skills.

  • Exceptional communication and stakeholder engagement abilities.

  • Problem-solving and Agile mindset and a track record of successful project delivery.

  • Regulatory certifications (e.g., RAC) are a plus.

Soft Skills

  • Strong communication, negotiation, and interpersonal skills

  • Demonstrated conflict resolution & problem-solving skills in a global environment

  • Strong appetite to learn and discover, entrepreneur mindset

  • Adaptable and open to change

  • Team player, service-oriented

  • Analytical and synthetic, able to formalize solutions, good writing skills

  • Strong oral and written communication skills

  • With leadership attitude, autonomy and results driven

  • Role model our 4 values: teamwork, integrity, respect, courage

Education:

  • Bachelor's degree in Information Technology, Computer Science or Regulatory Affairs.

  • Master’s degree preferred.

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, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

#GD-SA

#LI-SA

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.