• Location:Budapest, Hungary
• 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 our Renewals team to ensures the continuity of Sanofi drugs on the market, serving our patients' health. As a Regulatory Renewal Coordinator you will play a critical role in maintaining the Renewal Reference Plan, initiating the renewal submission process in line with regulatory requirements, and coordinating the renewal preparation workflow with stakeholders.

Main responsibilities:

• Ensure the submission of renewal dossiers to Health Authorities and dispatch to stakeholders in collaboration with Affiliates/Distributors, regions, and GRA Ops Submission teams
• Propose Renewal process simplification to Renewal Process Owner whenever harmonization and simplification are needed
• Prepare and maintain the Renewal Reference Plan (RRP) for worldwide registered products in the scope, ensure the implementation of processes, and support effective change management communications
• Represent Submission management team as Regulatory Renewal Coordinator and SME, providing efficient support to internal stakeholders and external teams on renewal activities
• Contribute to meetings and workshops related to renewal initiatives and tools and develop, produce, maintain, and enhance the appropriate tools and reports for managing the renewal dossier
• Collaborate with stakeholders to understand the global regulatory environment for Sanofi's business needs and propose action plans for Renewal preparation and submission to the Renewal Process Owner
• Participate in writing and reviewing quality documents related to renewals and produce and maintain up-to-date Renewal training materials
• Collaborate with external vendors to support renewal preparation and submission and perform KPI calculations for renewal submissions to ensure accurate input into the GRA Performance Dashboard

About you

Experience

• Experience in the pharmaceutical industry, with direct regulatory affairs experience in regulatory submissions
• Strong understanding of the drug development and marketed product license requirements

Soft Skills:

• Excellent communication skills with various stakeholders (RA affiliates, GRA regions, Product Leads, Submission Management team, Global Pharmacovigilance, Labeling, etc.)
• Capability to coach and guide stakeholders to prepare accurate and reliable planning
• Ability to organize/prioritize work assignments and projects independently, handling conflicting priorities in a constantly changing environment
• Ability to work in a matrix international environment with cross-functional teams
• Excellent coordination skills across several contributors to achieve high-quality and on-time submissions
• Project Management skills, including planning and execution

Technical Skills:

• Knowledge of data management in databases and working with Document Management Systems (e.g., VAULT RIM or related)
• Proficient in MS Word, PowerPoint, Excel, Adobe Acrobat, and collaborative work environment tools (e.g., SharePoint, Teams)
• Experience in PowerBI or familiarity with AI tools for regulatory document management and process automation is advantegous

Education:

• Bachelor's degree, or equivalent, in life sciences, regulatory affairs or equivalent, or related areas of study
  

Languages:

• A strong command of English (written and spoken) is needed to support efficient decision-making

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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