Global Submission Manager

Sanofi

Global Submission Manager applying expertise in managing submission types from standard to complex for the GRA portfolio. Collaborating with global teams to drive timely submission delivery.

Posted 5/10/2026full-timeMorristown • Massachusetts, New Jersey • 🇺🇸 United StatesMid-LevelSenior💰 $100,500 - $145,166 per yearWebsite

Tech Stack

Tools & technologies

Assembly

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

Bachelor’s degree in regulatory affairs, sciences, or related areas of study
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
High degree of knowledge of US regulatory submissions
Working knowledge of drug laws, regulations and guidelines is essential
Ability to work across cultures.

Benefits

Comp & perks

high-quality healthcare
prevention and wellness programs
at least 14 weeks’ gender-neutral parental leave

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

project managementregulatory knowledgedossier formatseCTDICHsubmission preparationpublishing activitiesGlobal Simultaneous Submissions (GSS)auditsissue resolution

Soft Skills

stakeholder engagementcross-functional collaborationcommunicationcultural awarenessproblem-solving

Certifications

Bachelor’s degree in regulatory affairsBachelor’s degree in sciences