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. Ready? As Publisher within our Global Regulatory Operations Team, you’ll be responsible for coordinating lifecycle submissions for the regional portfolio, working directly with key stakeholders, GRA focal points and publishing partners to ensure the submissions are prepared on-time and with high quality while meeting HA specifications. You will also partner with corresponding Submission Managers and Submission Leads to support the publishing and delivery of complex submission plans.
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?
Flexibility to work 3 pm – 11 pm local time collaborating with a team based in North America
Prepare and compile regional submission documentation to regulatory health authorities according to ICH / eCTD format and submission ready health authority standards, as well as Sanofi standards. Ensure end-to-end process adherence for routine maintenance submissions.
Perform quality control checks for submission publishing, understanding, and addressing validation criteria in detail, and troubleshooting.
Assist in improvement efforts of publishing processes and contribute to review and updates of quality documents.
Identify and raise submission technical issues in timely manner to ensure that resolutions are realized, enabled, and executed to deliver according to planned submission filing dates.
Maintain knowledge of regulatory requirements for document and submission assembly and publishing across various submission regions on a continuous basis.
Experience 1 to 2 years with relevant professional experience in Pharmaceutical Industry, with direct experience in Regulatory Operations with working knowledge of eCTD and eCTD publishing experience
High degree of technical knowledge regarding the dossier assembly/production process and the structural organization, standards and requirements of regulatory dossiers is required.
Proficiency working in eCTD publishing tools, RIM systems, MS Windows environment and with Windows-based desktop productivity applications (MS Office) including Adobe Acrobat technology is required.
Self-starter, who motivates and negotiates with an agile and positive approach.
Strong attention to detail and accuracy. Ability to work across cultures.
Bachelor’s degree or equivalent degree in regulatory affairs, the sciences, or related areas of study, and relevant experience.
Strong command of the English language, both spoken and written.
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.
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!