About the job
Our Team:
Join Sanofi's dynamicGlobal Submission Management (GSM) team, part of Global Regulatory Operations (GRO), where a diverse group of regulatory professionals work collaboratively across geographies to ensure timely, accurate, and compliant submissions to Health Authorities worldwide. The team operates at the forefront of regulatory innovation, continuously evolving to meet the demands of an ever-changing global regulatory landscape.
About Sanofi
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
As part of this high-impact team, the Submission Lead for Structured Data will play a key role in ensuring that medicinal product information is submitted to Health Authorities in standardized, structured formats - directly contributing to patient safety and regulatory efficiency at a global scale.
This includes working across key systems and frameworks, including:
xEVMPD- eXtended EudraVigilance Medicinal Product Dictionary
FMD- Falsified Medicines Directive
IDMP- Identification of Medicinal Products
PLM/PMS- Product Lifecycle Management portal using Product Management Service (PMS) data
Central to this role is theIDMP suite of standards, developed by the International Organization for Standardization (ISO) and actively implemented and monitored by Health Authorities globally.
Adopting standardized terminology and formats delivers real benefits across the regulatory ecosystem - enabling systems to work together seamlessly, strengthening drug safety monitoring, eliminating duplicate work, and making information exchange with and between regulatory authorities faster and more efficient.
Key Responsibilities
This Submission Lead position is part of the Global Regulatory Operations (GRO) group within the Global Submission Management Team.
Leadership & Operations
• Lead structured data operations end-to-end, including submissions, confirmations, and responses to regulatory inquiries
• Manage the complete business process from start to finish as the Business Process Owner
• Lead a team of contract and hub based structured data specialists to ensure Sanofi meets all compliance requirements
• Identify trends, opportunities, and risks that could cause late submissions; create action plans and escalate issues when needed
IDMP Implementation
• Support analysis and planning for transitioning from xEVMPD to IDMP systems to meet EU and global Health Authority requirements and deadlines
• Lead structured data implementation across Sanofi globally, ensuring we meet quality and timeline requirements
Regulatory Compliance & Monitoring
• Monitor changes to global structured data standards (including xEVMPD, IDMP, PMS) and help implement updates quickly
• Represent Sanofi in working groups with Health Authorities, industry partners, and vendors
• Write responses to structured data questions from Health Authorities and work with internal teams before submission
• Oversee quality control of company data before submitting to Health Authorities
Audit & Quality Support
• Provide expertise during audits and support inspection processes with required responses and reports
• Execute operational strategy and provide direction to the team
• Work with stakeholders to continuously improve structured data processes
Performance Management
• Monitor data quality and compliance in the submission process
• Track Global Regulatory Operations Key Performance Indicators (KPIs)
• Ensure KPI targets are met and report/escalate as needed
• Set up and monitor service agreements with vendors and contractors
Team & Resource Management
• Manage team workload to ensure productivity and efficient resource use
• Identify potential issues and project conflicts; resolve problems quickly and alert management when needed
• Stay current on system operations, configurations, and business requirements
• Consult with stakeholders on delays, action plans, and risks
Process Improvement & Documentation
• Maintain expertise in structured data processes and tools; ensure team does the same
• Support implementation of tool changes and new system projects
• Help create quality documents like SOPs, work instructions, user guides, and job aids
• Work with stakeholders to identify and resolve structured data process issues
• Complete other tasks assigned by the Head of Structured Data Strategy
About you
Experience Requirements
- 5+ years in pharmaceutical industry
- Minimum 3 years in regulatory affairs and/or regulatory data roles
- Strong knowledge of medicinal product information and global information standards
- Understanding of global regulatory environment and Regulatory Information Management (RIM) Systems
- Knowledge of pharmacovigilance regulations preferred
Essential Skills
- Proven ability to build effective working relationships across different departmentsStrong organizational and communication skills in matrix organizations
- Ability to multitask and work effectively in global team environments
- Customer-focused and action-oriented approachExperience leading multidisciplinary teams and working with senior management
- Strong influence and leadership skillsAbility to adapt to changing priorities while meeting project requirementsundefined
Technical Requirements
- Hands-on experience with structured data submission applications and RIM systemsundefined
Education & Languages
- Degree in Life Sciences, Information Technology, or related field preferred (not required)
- Fluent English (spoken and written) required, additional languages desirable
Why choose us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Benefit from a well-thought-out benefits package that rewards your contribution and commitment.
- We take care of you and your family with a wide range of health and social such as high-quality healthcare, numerous prevention programs and coverage for long-term illness. Our 14-week paid family leave for both parents is outstanding as well as a wide range of childcare benefits.
- Start your career at an attractive location in the center / in the capital of Germany and experience our modern working environment and benefit from hybrid, flexible working time models.
#LI-Hybrid
#SubmissionManagement
#Sanofi
#SanofiCareers
#PursueProgress
#DiscoverExtraordinary
#WeAreSanofi
#IgnitingPotential
Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.
The salary range for this position is :€83,856.00 - €111,808
Die endgültige Vergütung wird auf Grundlage nachgewiesener Erfahrung, Fähigkeiten, Standort und weiterer relevanter Faktoren bestimmt. Mitarbeitende können berechtigt sein, an den Mitarbeitenden Leistungsprogrammen des Unternehmens teilzunehmen.
