Job title: Product Owner– Regulatory Information Management (RIM)

• Location: Hyderabad

At Sanofi Consumer Healthcare, our Digital teams are committed to delivering exceptional solutions and services, with a passion for excellence to build a future where technology rapidly enhances and transforms Fast Moving Consumer Healthcare. Join our CHC Digital Health and Science team as Product Owner– Regulatory Information Management (RIM) and you can help make it happen.

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 CHC Digital Health and Science team as Product Owner– Regulatory Information Management (RIM) and you can help make it happen. Developing globally scalable AI and machine learning solutions that help us get new clinical products to patients faster and more efficiently.

About you

Key responsibilities:

• Product Vision and Strategy:
• Define and communicate a clear Product vision, roadmap, and strategy for Regulatory Systems (RIM, Submission Publishing, Advertising and Promotional Material, Regulatory Intelligence etc.) aligning with overall company goals and market trends.
• Continuously monitor industry trends, regulatory requirements changes, vendor updates and customer feedback to identify opportunities for product improvements and enhancements.
• Product Backlog Management:
• Maintain and prioritize the product backlog for the above stated regulatory applications, ensuring that user stories and requirements are clearly defined, properly sized, and aligned with the product vision and regulatory requirements.
• Facilitate backlog preparation sessions with the development team and subject matter experts to clarify requirements and ensure a shared understanding.
• Break down complex features into actionable tasks and user stories for development teams.
• Continuously refine and adjust the backlog based on changing priorities, regulatory requirements, and stakeholder feedback.
• Stakeholder Collaboration and Communication:
• Act as the primary point of contact for stakeholders, including regulatory affairs, quality, CMC, labelling, commercial, safety, pharmacovigilance, medical affairs, Compliance and Legal, Market Access and Reimbursement, Customer Relationship Management, etc.
• Gather requirements, feedback, and insights from stakeholders to ensure that the platforms meet their needs and address regulatory requirements and concerns.
• Effectively communicate product decisions, roadmaps, and progress to stakeholders, fostering transparency and building trust.
• Release Planning and Execution:
• Develop and maintain a product roadmap, outlining feature releases and product enhancements for all the Regulatory systems.
• Coordinate with cross-functional teams for testing, validation, and user acceptance, ensuring product quality and regulatory compliance.
• Risk Management and Compliance:
• Ensure that regulatory affairs technology products and processes, including Veeva Vault, submission publishing tools, and other platform used by Regulatory function is comply with relevant regulatory requirements, industry standards, and best practices.
• Identify and mitigate potential risks associated with product development, implementation, and maintenance, collaborating with risk management and quality assurance teams as needed.
• Stay up to date with regulatory changes and industry trends and adapt product strategies accordingly.
• Continuous Improvement:
• Continuously seek opportunities for process optimization, system enhancements, and user experience improvements for the systems within RIM platforms.
• Analyze product performance metrics, user feedback, and industry benchmarks to identify areas for improvement.
• Foster a culture of continuous learning and innovation within the team, encouraging collaboration and knowledge sharing.
• Experience:
• Proven Industry experience (10+ years) within the Lifesciences or consumer healthcare industry with bachelor’s degree in a relevant field (e.g., life sciences, pharmacy, healthcare, or Technology); advanced degree preferred.
• Strong Knowledge and Experience with Veeva RIM platform, Submission Publishing (eCTD, NeeS, Paper) & Validators (Extedo EURS & Lorenz), SPOR/IDMP, Submission Gateways, eAF, SPL, ePI, Veeva Promomats, Regulatory Intelligence and other regulatory digital applications.
• Possesses comprehensive knowledge of Quality Assurance and regulatory compliance, including 21 CFR Part 11 and FDA regulations, ensuring technology solutions meet industry standards.
• Strong problem-solving capabilities and a track record of successful project delivery.
• Proven experience in regulatory technology product management, preferably in the pharmaceutical or healthcare industry, with a strong understanding of regulatory submission processes and heath authority digital requirements.
• Soft and technical 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 a relevant field, master’s degree preferred.
• Languages: Fluent spoken and written English

Pursue Progress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, 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!

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 and check out our Diversity Equity and Inclusion actions at sanofi.com!

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