Sanofi
biopharma
GlobalSubmissionAssociate
“Global Submission Associate at Sanofi. Skills: eCTD publishing, regulatory affairs, submission coordination. Coordinate lifecycle submission requests. Prepare, compile and review regional submission documentation”
What You'll Achieve.
ensure the submissions are prepared on-time and with high quality; meeting Health Authority (HA) specifications; support the publishing and delivery of complex submission plans; ensure that resolutions are realized, enabled and executed to deliver according to planned submission filing dates
Industry & Context.
troubleshooting; identify critical technical issues; propose creative and achievable solutions
What They're Looking For.
Must Have
Bachelor's degree in regulatory affairs, sciences, or related areas, 3+ years of experience in the pharmaceutical industry, direct regulatory affairs experience, eCTD publishing tools and platforms, Knowledge of regulatory submission requirements for at least one of: US, Canada, or EU, Dossier assembly and technical standards (eCTD structure, modules)
Nice to Have
Working knowledge of drug laws, regulations and guidelines, Proficiency in publishing and technical review of Module 4 and 5 datasets, Understanding of global regulatory requirements, global submission processes (re. EMA work sharing), drug development process, Veeva, RIM systems, DMS systems, Maintain independent abilities to learn quickly and adapt to new technologies/environments, Ability to implement and manage global regulatory technology solutions to streamline processes, Ability to identify critical technical issues and propose creative and achievable solutions through technical expertise and troubleshooting, attention to detail and accuracy, Ability to operate with agility in a dynamic global environment, Ability to maintain discretion and confidentiality about sensitive data, Ability to communicate and collaborate on many levels, including issue escalation to GRA leadership, Ability to work across cultures
What You'll Do.
Coordinate lifecycle submission requests
compile and review regional submission documentation
Ensure end-to-end process adherence
Perform quality control checks
Assist in improvement efforts
Identify and raise submission technical issues
How You'll Work.
Team & Collaboration
working directly with key stakeholders; working with GRA focal points; working with publishing partners; Partner with Submission Managers; Partner with Submission Leads; Collaborate and support third-party vendors; Provide guidance to project teams; communicate and collaborate on many levels
Communication Scope
Excellent verbal and written communication ability
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