• Location: Budapest
• Flexible working: 60% home, 40% office
• Job type: Permanent, Full-time
  

About the job

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.

Join us as European Regulatory Coordinator, and you mission will be to facilitate the preparation of Swiss regulatory dossiers and support a broad range of regulatory activities essential for successful submissions in Switzerland. As a member of the R&D Budapest Hub Submission Excellence team, you will collaborate closely and continuously with Regulatory Affairs Managers (RAMs) responsible for Switzerland, providing support to ensure compliance, accuracy, and timeliness in all submission-related processes.

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?

Main responsibilities:

• Compile Swiss dossiers from the dispatched/provided documents in alignment with national regulatory requirements and established Sanofi processes.
• Prepare Module 1 documents for submission, deliver the finalized Submission Content Plan (SCP) structure for various submissions (e.g., Initial Marketing Authorization Applications (MAA), responses to Health Authority requests for supplementary information, variations, post-approval changes (PAC), Periodic Benefit-Risk Evaluation Reports (PBRER)) in the regulatory database.
• Initiate and manage the Request for Publishing (RFP) process within the regulatory database, ensuring timely and accurate execution.
• Oversee the end-to-end Swiss dossier management process until successful submission to Swissmedic
• Collaborate with RAM, Submission Managers, and Publishing Managers to ensure the thorough preparation of dossiers in accordance with established processes.
• Apply expertise in regulatory business data, system data models, and technical skills to analyze and fulfill requirements for Swiss and EU regulatory information, reports, and analytics

About you

Experience:

• 1 year of experience in a Swiss or EU regulatory affairs department within pharma industry
• Proven experience in managing activities that require both short- and long-term planning and monitoring capabilities

Soft skills:

• Ability to quickly grasp new concepts and learn efficiently
• High degree of accuracy, coupled with flexibility and adaptability to evolving requirements

Technical skills:

• Good IT skills in, e.g. MS Office are essential, for planning, tracking, communicating and reporting
• Understanding of the interaction between regulatory systems and electronic databases
• Basic understanding of eCTD dossier requirements

Education: Pharmacist / Scientist or other degree with first experience in Regulatory Affairs or other relevant experience

Languages: Fluency in English is required, knowledge of German language is a plus

Why choose us?

• 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 sanofi.com!

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.

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