Sanofi
Biopharma
GlobalSubmissionAssociate
“Global Submission Associate at Sanofi. Skills: eCTD publishing, regulatory affairs, submission coordination, pharmaceutical industry. Coordinate lifecycle submission requests. Partner with GBU and regional submission platforms”
What You'll Achieve.
ensure the submissions are prepared on-time and with high quality; meet 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; streamline processes
Industry & Context.
troubleshooting; Identify and raise submission 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, 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, 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
Partner with GBU and regional submission platforms
Provide guidance on submission structure strategies
Collaborate and support third-party vendors
compile and review regional submission documentation
Ensure end-to-end process adherence
Perform quality control checks
Assist in improvement efforts of publishing processes
Identify and raise submission technical issues
Maintain knowledge of regulatory requirements
How You'll Work.
Team & Collaboration
working directly with key stakeholders; GRA focal points; publishing partners; Submission Managers; Submission Leads; project/product teams; local affiliates; project teams; third-party vendors; communicate and collaborate on many levels; issue escalation to GRA leadership; work across cultures
Communication Scope
Excellent verbal and written communication ability; communicate effectively to multiple levels in the organization
Process & Methodology
workload prioritization, GSS plans, manage global regulatory technology solutions
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