Global Regulatory Data & KPIs Team Lead

Job title: Global Regulatory Data & KPIs Team Lead

• Location: Hyderabad

At Sanofi Consumer Healthcare, our Science Hub mission is to empower our consumers to take Health in their Hands! With your talent and ambition, we can do even more to build our Sciences activities and develop breakthrough innovations for consumers worldwide. Your job, as Global Regulatory Maintenance Team Lead within our Scientific Communications/Education

Main responsibilities:

• Lead and manage a team of regulatory affairs professionals, including roles focused on electronic documentation, clinical document management, process improvement, data management, and compliance. 

• Provide coaching, mentoring, and professional development opportunities to team members, fostering a collaborative and high-performance work environment. 

• Ensure effective resource allocation, balancing workload, and priorities to meet business objectives and regulatory deadlines. 

• Oversee the development, validation, and submission of clinical and regulatory documents, ensuring compliance with applicable regulations and internal quality standards. 

• Manage the end-to-end process for creating, compiling, and publishing regulatory submissions in electronic Common Technical Document (eCTD) format and other required formats. 

• Ensure that all documentation follows established naming conventions, metadata requirements, and other standard operating procedures within the electronic Document Management System (eDMS). 

• Develop and implement a robust continuous improvement strategy to enhance regulatory processes, including identifying opportunities for efficiency gains and process optimization. 

• Monitor regulatory performance metrics (KPIs/KCIs) and lead initiatives to enhance data quality, compliance, and operational effectiveness across global, regional, and local teams. 

• Stay current with evolving regulatory requirements and industry best practices to ensure the company remains compliant and competitive. 

• Oversee the strategic development and management of regulatory data and technology, ensuring alignment with business objectives and corporate strategy. 

• Manage the deployment of new tools and systems, including Veeva Vault and other relevant technologies, to improve regulatory data management and reporting capabilities. 

• Collaborate with IT and other stakeholders to ensure the operational stability and compliance of the regulatory affairs application landscape. 

• Act as the primary liaison between Regulatory Affairs, Clinical, Medical Writing, Pharmacovigilance, and other key stakeholders to ensure alignment and effective communication. 

• Lead and participate in cross-functional teams and working groups to address regulatory challenges, share best practices, and drive strategic projects. 

• Communicate regulatory strategies, process improvements, and compliance updates to senior management and relevant stakeholders. 

• Lead strategic projects from initiation to completion, including planning, resource allocation, risk management, and stakeholder engagement. 

• Develop and execute change management strategies to support the successful adoption of new processes, tools, and technologies within the regulatory affairs function. 

• Provide regular updates on project progress, challenges, and achievements to senior management and other relevant committees. 

• Collaborate with Global Science CoE Head to support on any additional activities.

About you

• Experience: Experience in the Pharmaceutical or biopharmaceutical industry, ideally 8+ years in data science, regulatory affairs, or a related field. Proven leadership and team management skills  
• Soft skills: Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions. Proven leadership and team management skills. Excellent organizational and project management abilities. Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment.
• Technical skills: Extensive experience in regulatory data management and compliance. Proven experience in designing and implementing KPI frameworks. Strong analytical skills, with the ability to analyze complex data sets and identify trends and insights.Strong knowledge of regulatory documentation processes, eCTD submissions, data management, and relevant technologies (e.g., Veeva Vault, RIM systems). Familiarity with global regulatory requirements and guidelines.
• Education: Master's degree in a scientific discipline, regulatory affairs, or a related field.
• Languages: Fluent in English (verbal and written)

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.
• prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
• 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.

PursueProgress. 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