R&D Submission & Document Services Lead

Job title: R&D Submission & Document Services Lead

• Location: Hyderabad

About the Position

Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As Head, R&D Submission & Document Services within our Hyderabad Hub, you’ll be responsible for managing a diverse team of regulatory professionals responsible for delivering high quality, compliant documents and dossiers to support Sanofi’s product portfolio. It’s a chance for you to make an impact for key internal stakeholders and our patients.

R&D Submission & Document Services’ culture is focused on a deep commitment to operational excellence.  Maximizing team growth via training and development as a standard strengthens our capabilities and continuously helps us reach new levels of effectiveness.  Harnessing new technologies and applying them to our processes drives further efficiency that supports our ultimate responsibility: progressing the pipeline via timely and high-quality documents and dossiers for submission to Health Authorities. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Key Responsibilities

• Team Leadership: Provide direct supervision and management to a diverse team of submission professionals, electronic document specialists, and document specialists procuring ancillary documents

• Documentation Management: Contribute to revisions/updates of work instructions and supportive documents; train team members on processes as needed

• Intentional Partnership: Partner with Head, Global Submission Management and team, and peers/colleagues to provide oversight to support departmental goals and quality standards

• Process Excellence: Oversee standards and process efficiencies while supporting effective change management across departmental and R&D stakeholders

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• Talent Development: Oversee onboarding of new team members ensuring completion of related on-boarding documentation procedures

• Cultural Leadership: Embody and promote the One Sanofi vision in Regulatory Operations excellence across a global matrix organization

Direct Team Activities:

• With a continuous process improvement team mindset, efficiently deliver top quality documents and timely submissions to health authorities.

• High-level oversight of document preparation and global submissions to confirm that all processes and procedures are being followed, that timelines will be adhered to and all Sanofi and Health Authority standards are met.

• Ensure staff is delivering activities in a timely and high-quality fashion.

• Provide subject matter expertise in document, dossier types/processes with responsibility for training/mentoring staff.

• Support submission and technical issue resolution, as needed.

• Participate in project teams, working groups and/or task forces, as required.

• Provide input for strategic decisions led by functional teams and support the execution of those initiatives.

• Drive Operational Excellence: Support a focused, quick acting, flexible and unified team; stay up to date with industry changes and trends and continuously meet organizational pipeline submission demands.

• Assist in compilation of departmental metrics and performance goals.Strive for continuous improvement and development of systems and procedures.Conceptualize new processes to drive efficiencies.

• Oversee the implementation and sustained management of supporting procedural documentation and tools for regulatory submission assembly (user guides, work instructions).

• Proactively identify, evaluate, and implement innovative technological solutions in partnership with functional teams to streamline processes, enhance efficiency, and drive operational excellence. 

• Performance Management: Mentor direct reports and team members, as needed. Manage direct reports’ performance, as per objectives, goals and assessments. 

About you 

• Experience: Extensive experience in the pharmaceutical industry with diverse regulatory experience; including regulatory operations experience with a strong technical aptitude with various software/troubleshooting.

• Demonstrated ability to lead teams and collaborate with functional partners. Able to operate with discretion and confidentiality about sensitive data.

• Soft and technical skills: Proven ability to engage with excellent verbal and written communication skills to effectively collaborate with multiple levels in the organization. Ability to manage simultaneous priorities while leading projects with proven track record to meet timelines Strong attention to detail and accuracy; apply project management skills to appropriate activities. Possess advanced working knowledge of eCTD standards, including CTD methodology Demonstrated and recognized capacity to identify critical submission or publishing issues and propose creative and achievable solutions; determines the causes and find efficient solutions. 

• 5+ years’ experience in managing teams in a matrixed environment and demonstrated leadership abilities with strong negotiating/influencing skills and effective people management. Undefined

• Education: At least a bachelor’s degree, or equivalent, (master’s preferred) in regulatory affairs, the sciences or related areas of study.

​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, with international mobility options. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and supports your wellbeing. 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. Play a pivotal role in preparing high quality document and dossiers to be submitted to various Health Authorities.