🌍 Job Title: Global Submission Manager
🏢 Company: Sanofi
📍 Location:
Cambridge, Massachusetts, USA
Morristown, New Jersey, USA
💰 Salary Range:
USD 100,500.00 – 145,166.66
🔬 About the Job
Are you ready to shape the future of medicine?
Join Sanofi in accelerating drug discovery and development to find answers for patients worldwide. As a Global Submission Manager, you’ll lead global submission operations, manage complex regulatory submissions, and collaborate with cross-functional teams to ensure timely, high-quality delivery of regulatory dossiers across markets.
You’ll represent Global Regulatory Operations (GRO) on Global Regulatory Teams (GRTs), providing submission expertise and insight into development plans, ensuring global regulatory excellence and compliance.
🧩 Main Responsibilities
Manage global submission projects (standard to complex) using strong project management and regulatory expertise.
Ensure high-quality submissions aligned with Health Authority and Sanofi standards.
Represent GRO Global Submissions Management on:
Global Regulatory Teams (GRTs)
Submission Task Force (STF) meetings
Partner closely with Submission Leads and Publishers to execute global filing plans.
Drive Global Simultaneous Submissions (GSS) and manage submission timelines.
Provide guidance on dossier formats, lifecycle management, and eCTD standards.
Lead discussions on electronic submission guidance and regulatory requirements.
Act as Subject Matter Expert (SME) during audits, inspections, and special projects.
Support implementation of new technologies and digital submission tools.
May include supervisory responsibilities over submission associates or publishing teams.
🎯 About You
Knowledge & Skills
Deep understanding of global submission standards and regulatory requirements.
Expertise in eCTD, ICH guidelines, and dossier assembly processes.
Strong project management and cross-functional collaboration abilities.
Skilled in publishing tools, RIM systems, and MS Office / Adobe Acrobat.
Excellent attention to detail, communication, and negotiation skills.
Capable of managing complex timelines in a matrixed global environment.
Self-motivated, agile, and solutions-driven with strong leadership qualities.
🎓 Qualifications
Bachelor’s degree (Science, Pharmacy, Regulatory Affairs, or related discipline).
5+ years of experience in the pharmaceutical industry.
Direct regulatory affairs and submission management experience required.
Solid knowledge of drug laws, regulations, and dossier organization.
Strong English communication (verbal and written).
Willingness for domestic/international travel (up to 10%).
Ability to maintain confidentiality and discretion with sensitive data.
🌟 Why Choose Sanofi?
Be part of a future-focused, innovative global team.
Grow your career through promotions or global mobility.
Comprehensive health & wellbeing benefits.
14 weeks of gender-neutral parental leave.
Equal Opportunity Employer — committed to diversity, equity, and inclusion.
#Tags
#RegulatoryAffairs #GlobalSubmission #PharmaceuticalJobs #GRA #Sanofi #LI-Onsite #GD-SA
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