About the job
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. As a Submissions Management team lead within our Hyderabad Hub, you’ll be leading a team of Submission Managers and Submission Publishers.
The Americas Submissions Platform culture is focused on a deep commitment to operational excellence. Maximizing team growth via training and development as a standard strengthens our regional submission 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 submissions 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?
Role includes supervisory responsibilities for a team of Submission Managers and Submission Publishers. Oversees standards and process efficiencies for submissions and supports effective change
Contributes to revisions/updates to Work Instructions and supportive documents. Trains team members as needed on processes. Partner with Team Lead, Americas Submissions Publishing, and peers/colleagues to provide oversight to support regulatory submission goals and quality.
Oversee onboarding of new Submission Managers and Submission Publishers ensuring completion of related on-boarding documentation procedures and documentation. Share in One Sanofi vision in Regulatory Operations excellence.
With a continuous process improvement team mindset, efficiently deliver top quality and timely submissions to Americas Submissions Platform related health authorities. High-level oversight of routine maintenance submissions in the Americas Submissions Platform to confirm that all processes and procedures are being followed, that timelines will be adhered to and all Sanofi and Health Authority standards are being met based on the submission type.
Provide subject matter expertise in 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.
Support a focused, quick acting, flexible and unified Submissions Management 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. Develop, author and maintain supporting procedural documentation and tools for regulatory submission assembly (user guides, work instructions). Utilize new technologies to their highest capabilities, while maximizing team potential via training and development opportunities. Mentor direct reports and team members, as needed.
Bachelor’s Degree, or equivalent, in regulatory affairs, the sciences or related areas of study.
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.
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
Demonstrated and recognized capacity to identify critical submission or publishing issues and propose creative and achievable solutions; determines the causes and find efficient solutions.
Demonstrated leadership abilities with strong negotiating/influencing skills and effective people management.
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.
Build, develop and manage a statistics team support multiple TAs and different clinical phases
Develop a career of being an influential statistician
Gain international clinical trial experiences and communicate with Health Authorities worldwide
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!