Sanofi · 1 day ago
Global Submission Manager
Cambridge, MA
Full-time
Onsite
Senior Level
5+ years expSanofi is an innovative global healthcare company dedicated to improving people’s lives through science. The Global Submission Manager is responsible for managing all submission types for the GRA portfolio, collaborating with global teams to ensure high-quality and timely submission delivery, and acting as a subject matter expert in regulatory affairs.
Health CareLife SciencePharmaceuticalTherapeutics
Responsibilities
Applies project management skills and regulatory knowledge for global submission types, from standard to complex
Applies expert understanding on all dossier formats, standards, navigation and lifecycle management, eCTD, and ICH
Represents GRO Global Submissions Management on Global Regulatory Teams (GRTs) for assigned development and marketed products portfolio, per the GRA BluePrint model
Represents GRO Global Submissions Management on Submission Task Force (STF) meetings for major/complex submission filings and partner effectively with regulatory focal points on the Ops-specific details of lifecycle submissions
Leads discussions with stakeholders and submission task force teams involving electronic guidance issues to ensure an appropriate understanding of electronic submission requirements from a cross-functionally perspective, supporting successful submissions. Works within project teams in the control of submission component receipt and adherence to submission preparation completion
Directs the publishing activities for assigned portfolio to ensure high quality and timely submission delivery aligned to both Sanofi and Health Authority standards
Partners effectively with Submission Leads and global colleagues to deliver high quality and timely Global Simultaneous Submissions (GSS) filing plans, while also providing regional expertise
Acts as Subject Matter Expert (SME) in audits/inspections, special projects and issue resolution for regional activities
Partners with GRA and Digital functions as SME for current processes/data/technologies, as well as evaluating and implementing new/emerging technologies and requirements
May be assigned supervisory responsibilities
Qualification
Required
Bachelor's degree, or equivalent, in regulatory affairs, the sciences, or related areas of study
Minimum 5+ years of experience in the pharmaceutical industry, with direct regulatory affairs experience
High degree of knowledge regarding the dossier assembly/production process and the structural organization, standards and requirements of regulatory dossiers is required
Working knowledge of drug laws, regulations and guidelines is essential
Strong command of the English language, both spoken and written
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 leaderships
Expert knowledge of global submission standards and specifications
Strong understanding of global regulatory requirements, submission processes and the drug development process
Experience in planning, coordinating and managing different stages of submission development
Expertise in the eCTD process, document management environments/systems, publishing tools and submission software
Maintain independent abilities to learn quickly and adapt to new technologies/environments
Self-starter, who motivates and negotiates with an agile and positive approach
Demonstrated leadership ability, with strong negotiating and influencing skills
Ability to lead complex projects and timelines in a matrix team environment
Ability to identify critical issues and understand complex issues and propose creative and achievable solutions through using appropriate information. Determines the causes and possible solutions to the problem
Strong attention to detail and accuracy
Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization
Ability to cultivate internal and external relationships
Applicable knowledge of the drug development process
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
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.97BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2026-01-06
BioWorld Financial Watch
2026-01-06
2026-01-06
Company data provided by crunchbase