Regulatory Data Strategy and Governance Lead

Company Overview:

Opella, a consumer healthcare business unit of Sanofi, focuses on Over-The-Counter (OTC) products and Vitamins, Minerals, and Supplements (VMS). Opella is the third-largest global player in this market and is committed to empowering individuals to take charge of their health. Their product portfolio includes over 100 brands, such as Allegra, Dulcolax, and Buscopan, which are trusted by over half a billion consumers worldwide. Opella strives to lead the industry with science-based, consumer-driven self-care products and has earned B Corp certification for their commitment to sustainability.

Key Responsibilities:

As the Regulatory Data Strategy and Governance Lead, you will play a critical leadership role in shaping and executing Opella’s regulatory data governance strategy. Your responsibilities include:

Development and Leadership of Data Strategy and Vision:

• Lead and Develop the Regulatory Data Strategy: Drive the vision, roadmap, and execution of the data governance strategy for regulatory affairs (GRA), Master Data Management (MDM), and Structured Data Strategy (SDS). You’ll create a clear plan to align all data initiatives with Opella’s business and regulatory goals.
• Data Governance and Compliance: Ensure regulatory data governance and compliance processes are well-defined, including data quality standards, data mapping, and information flow across systems.

Team Management and Leadership:

• Manage Functional Leads: Oversee the work of the Leads within Data Governance, MDM, and SDS functions. Mentor and provide leadership to a team of project managers, analysts, and support staff, ensuring that all projects under these capabilities are executed successfully.
• Collaborative Leadership: Work cross-functionally with various teams (e.g., Digital, R&D Data Office, M&S Data Office) to ensure that data strategies and projects are harmonized across the organization and meet evolving regulatory requirements.
• Transversal Collaboration: Lead efforts to establish data standards, definitions, and processes that will be adopted organization-wide and beyond. Drive coordination with stakeholders across various regulatory bodies and operational teams.

Project Oversight and Management:

• Oversee Project Delivery: Ensure successful project execution within the GRA DG, MDM, and SDS roadmaps. Monitor project progress and provide support where necessary to meet deadlines and quality expectations.
• Global Project Representation: Represent Opella and Sanofi in internal and external regulatory projects related to data strategy, governance, mapping, and master data management. This includes collaborating with industry bodies and ensuring alignment with global regulatory frameworks.

Strategy and Standards Alignment:

• Define and Implement Data Standards: Establish and enforce best practices for data governance, ensuring alignment with industry standards (e.g., ISO IDMP). Ensure consistent regulatory data practices across regions, including compliance with FDA, EMA, ICH, and other relevant guidelines.
• Data Flow Management: Lead the design and implementation of standardized data flows to ensure accurate and timely regulatory data sharing and reporting.

Skills & Competencies:

To excel in this role, you’ll need the following skills and expertise:

Regulatory Knowledge:

• A deep understanding of global regulatory requirements (EMA, FDA, ICH) and compliance, especially related to data, is critical.
• Familiarity with data standards such as ISO IDMP and controlled vocabularies for regulatory data is essential.

Strategic Thinking:

• The ability to think strategically and translate business and technical objectives into actionable data strategies, roadmaps, and projects.
• Ability to align data governance objectives with broader business and regulatory goals, driving continuous improvement in data processes.

Leadership and Team Management:

• Proven leadership experience managing cross-functional teams in a fast-paced, global environment.
• Ability to mentor and guide team members, ensuring that they meet project milestones and deliver high-quality outputs.

Data Governance & Compliance Expertise:

• Strong expertise in data governance principles, master data management, and structured data strategy.
• Experience implementing data standards, ensuring data quality, and maintaining compliance with relevant industry regulations.

Collaboration & Communication:

• Exceptional interpersonal, communication, and negotiation skills to engage with various stakeholders, including senior leadership, regulatory authorities, and cross-functional teams.
• Collaborative mindset to drive changes and align diverse teams around common goals.

Project Management:

• Experience in leading complex, global projects involving regulatory data, governance, and compliance requirements.
• Ability to manage multiple projects simultaneously, balancing priorities, timelines, and resources effectively.

Qualifications:

• Educational Requirements:
  • A Bachelor’s degree in Science, Engineering, or a related field is required; a Master’s in a relevant discipline is preferred.
• Experience:
  • 15+ years of experience in the pharmaceutical industry with a strong background in regulatory affairs, data governance, or data management.
  • Demonstrated success in driving cross-functional teams to establish governance, data standards, and data quality processes across global operations.
• Industry Knowledge:
  • Extensive knowledge of the regulatory domain and data-related compliance requirements globally and regionally (e.g., EMA, FDA, ICH).
  • Ability to navigate the complexities of global regulatory standards and adapt to changing industry needs.

Why Join Opella (Sanofi):

• International Work Environment: Work with a diverse, globally distributed team where you can develop your skills and contribute to innovations that impact healthcare.
• Flexible Work Options: Sanofi offers a flexible working model with the option to work up to 60% of your time from home.
• Career Development: Sanofi is committed to fostering both professional and personal development. They provide structured onboarding, continuous training, and mentorship from senior leaders.
• Competitive Compensation and Benefits: Attractive salary package with market-oriented salary, cafeteria benefits, life and accident insurance, and yearly medical check-ups.
• Diversity and Inclusion: Sanofi is committed to diversity, ensuring that all employees are respected and empowered to contribute their best work.

This position offers a unique opportunity for a seasoned professional to influence data governance strategy within a leading global healthcare company. If you have strong expertise in regulatory data management and governance, along with a passion for driving strategic change, this role could be a perfect fit.

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