eGSM Lead (Global Submission Management)

Job title:  eGSM Lead

The eGSM (eGlobal Submission Management) Lead is a strategic position responsible for driving innovation and acceleration in Common Technical Document (CTD) submissions to health authorities. This role champions process optimization through artificial intelligence and automation technologies, with the goal of enhancing efficiency, quality, and speed of regulatory submissions.

The eGSM Lead serves as the primary representative of Global Regulatory Operations (GRO) in CTD acceleration initiatives and works collaboratively across organizational boundaries to implement transformative solutions.

About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities:

Strategic Leadership & Process Optimization

• Develop and execute the strategic vision for CTD submission acceleration, aligning with organizational goals and regulatory requirements

• Partner with the Business Process Owner (BPO) in the identification, evaluation, and implementation of process optimization opportunities throughout the CTD submission lifecycle

• Design and implement innovative workflows that reduce cycle times while maintaining or improving quality standards

• Establish metrics and KPIs to measure the effectiveness of process improvements and automation initiatives

• Provide regular reporting on optimization progress, challenges, and outcomes to senior leadership

AI & Automation Implementation

• Identify opportunities to leverage artificial intelligence, machine learning, and automation technologies in CTD submission processes

• Collaborate with Digital, DDAI, and external vendors to develop and implement AI-driven solutions

• Collaborate with Digital, DDAI, and external vendors on proof-of-concept initiatives to validate new technologies before full-scale implementation

• Ensure compliance with data integrity and security requirements when implementing new technologies

GRO Representation & Cross-functional Collaboration

• Serve as the primary representative of Global Regulatory Operations in CTD acceleration initiatives

• Establish and maintain effective working relationships with Global Regulatory Affairs (GRA), Digital, Research & Development (R&D), and other key stakeholders

• Facilitate cross-functional workshops and working groups to identify pain points and develop collaborative solutions

• Communicate GRO capabilities, constraints, and requirements to partner organizations

• Align submission acceleration initiatives with broader organizational strategies and priorities

Submission Process Streamlining

• Partner with the Business Process Owner (BPO) to conduct comprehensive analyses of current CTD submission processes to identify bottlenecks and inefficiencies

• Develop standardized templates and tools to enhance consistency and reduce manual effort

• Partner with the Business Process Owner (BPO) to implement lean methodologies to eliminate non-value-added activities in the submission process

• Design and implement electronic review and approval processes to replace paper-based and manual workflows

• Establish continuous improvement mechanisms to ensure ongoing optimization of submission processes

Change Management & Knowledge Transfer

• Develop and execute change management strategies to support the adoption of new processes and technologies

• Create training materials and conduct knowledge transfer sessions for teams involved in CTD submissions

• Establish communities of practice to share best practices and lessons learned

• Manage resistance to change through effective communication and stakeholder engagement

• Document process improvements and technological innovations for future reference and scalability

Key Partnerships & Stakeholder Management

• Global Regulatory Affairs (GRA): Collaborate on regulatory strategy alignment and ensure submission processes meet regulatory requirements

• Research & Development (R&D): Partner to streamline the flow of scientific data into CTD submissions

• Digital: Work closely with digital partners to implement technological solutions and ensure system compatibility

• DDAI: Collaborate on the development and implementation of AI-driven solutions

• Quality: Ensure all process changes maintain compliance with quality standards

• External Vendors & Consultants: Manage relationships with technology providers and industry experts

• Health Authorities: Stay informed of evolving submission requirements and electronic gateway specifications

Innovation & Technology Focus Areas

• Artificial Intelligence for document review, quality control, and content generation

• Robotic Process Automation (RPA) for repetitive tasks in the submission process

• Natural Language Processing (NLP) for content analysis and consistency checking

• Machine Learning algorithms for predictive analytics and risk assessment Cloud-based collaboration tools for enhanced cross-functional teamwork

• Electronic document management systems optimization

• Automated validation and verification tools for submission readiness

Performance Expectations

• Achieve measurable reduction in CTD submission preparation time and resource requirements

• Successfully implement at least 2-3 major process optimization initiatives annually

• Demonstrate quantifiable improvements in submission quality metrics

• Maintain or improve regulatory submission acceptance rates

• Develop and maintain a roadmap of innovation initiatives with clear timelines and deliverables

• Build strong cross-functional relationships that facilitate collaborative problem-solving

• Stay current with emerging technologies and regulatory trends relevant to CTD submissions

About You

Required Competencies

• Strategic Thinking: Ability to develop long-term vision and translate it into actionable plans

• Process Optimization: Expert knowledge of process analysis, lean methodologies, and continuous improvement

• Technical Acumen: Understanding of AI, automation technologies, and their application in regulatory contexts

• Regulatory Knowledge: Comprehensive understanding of CTD structure, content requirements, and submission processes

• Change Leadership: Proven ability to lead organizational change and drive adoption of new processes

• Stakeholder Management: Excellence in building relationships and influencing across organizational boundaries

• Project Management: Strong skills in managing complex, cross-functional initiatives

• Communication: Exceptional ability to communicate complex technical concepts to diverse audiences

• Problem-Solving: Creative approach to identifying solutions to complex regulatory and technical challenges

• Data Analysis: Capability to leverage data to identify trends, opportunities, and measure outcomes

Qualifications:

• At least a bachelor’s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study, and relevant experience

• Experience in the pharmaceutical industry with at least 10 years of regulatory operations experience. High degree of knowledge regarding the dossier assembly/production process and the structural organization, standards and

• requirements of regulatory dossiers is required.

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. 

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.