Submission Excellence Lead R&D Budapest Hub

• Job title: Submission Excellence Lead R&D Budapest Hub
• Location: Budapest, Hungary
• Job type: Permanent, full-time
• Hybrid working (60% office and 40% HO)
  

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

We are currently on a journey transforming how we support our Global Regulatory Affairs (GRA) organization, and we are looking for passionate leaders to grow with us in this exciting phase.

The Sanofi R&D Hub in Budapest is seeking a Submission Excellence Lead, a people manager role leading regulatory professionals who are at the core of Sanofi's global and European submission activities. The role combines direct line management of two key operational regulatory teams-Regulatory Project Coordinators (RPCs) and EU Platform Regulatory Coordinators - complemented by a smaller but strategic scope supporting GRA's Portfolio Strategy activities, such as regulatory risk management tools and training programs.

This position is ideal for an experienced regulatory professional with a strong background in global and EU regulatory operations, combined with a demonstrated ability to lead teams, drive process excellence, and ensure quality in submission delivery.

Main responsibilities:

• Solid Line Management: Provide direct people leadership to a team of 15 professionals, primarily focused on submission coordination and operational support, also includes line management of a Portfolio Strategy contributor, supporting risk tools, data privacy, and GRA Blueprint training to strengthen strategic regulatory practices.
• Operational Excellence: Ensure timely and compliant delivery of global and EU submissions by monitoring capacity, prioritizing workload, and resolving roadblocks.
• Capability Building: Support the growth and development of individuals by guiding performance goals, development plans, and feedback routines.
• Process and Quality Oversight: Ensure high-quality execution of regulatory activities by coordinating timely reviews, managing system workflows in Veeva Vault and EMA IRIS, and supporting submission-readiness across projects.
• Best Practice Sharing: Harmonize and standardize ways of working across the two core teams, promoting cross-learning and continuous improvement.
• Stakeholder Alignment: Act as a point of contact for relevant operational and planning discussions with global and EU regulatory strategy teams.

Experience:

• 6+ years of experience in the pharmaceutical industry, in Regulatory field with strong understanding of global and EU regulatory processes, Health Authority submission lifecycles, and system compliance (e.g., Veeva Vault RIM, IRIS).
• 2+ years in a people or project leadership role, with demonstrated ability to drive performance and manage timelines.

Knowledge, soft skills and competencies:

• People Leadership: proven ability to coach, guide, and develop talent within regulatory or similar environments.
• Problem Solver & Process Thinker: Ability to identify operational pain points and lead change initiatives in a pragmatic, efficient way.
• Cross-functional Communicator & Stakeholder Manager: Strong ability to work collaboratively within a matrix organization, engaging effectively with key stakeholders such as Regulatory Strategists (RS), Global Regulatory Leads (GRL), cross-functional submission teams, and other GRA contributors. Builds trust and ensures alignment across all levels of the regulatory delivery chain.
• Adaptable & Resilient: Comfortable working in a dynamic environment with changing priorities and cross-team dependencies.
• Quality & Compliance Mindset: Familiar with regulatory documentation standards, process KPIs, and data integrity principles.

Technical skills:

• Skilled in MS Office and comfortable using regulatory platforms and dashboards.

Education:

• Min. Bachelor's degree (or equivalent) in Life Sciences, Pharmacy, or a related field.

Languages:

• Excellent written and verbal communication skills in English.

• Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment
• Work from an "Office of the Year 2023" award winner with flexible home office policy
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave
• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks
• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

Pursue Progress . Discover Extraordinary .

Progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at !

Discover our Code of Conduct , that serves as the moral compass that guides us when chasing the miracles of science to improve people's lives. Please ensure to have read this document before applying.

&D