Location: Budapest, Hungary
Job type: maternity cover, fixed-term (with end date of 2027. 12. 31. )
Hybrid working (60% office, 40% home)
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?
Main responsibilities:
Maintenance / digital regulatory activities
Deliver key start and follow-up of submissions, Initial/HA Request for Supplementary Information as per plan/requests for Sanofi products including European procedures (Worksharing, MRP/DCPs & CPs) and for deferred action countries following the approval of EU reference countries:
Set up kick off meeting (KOM) with stakeholder
Prepare and customize final dossier SCP/Binder structure as applicable.
Preparation of administrative documents: letter of intent (LOI), Cover letter, eAF via PLM if applicable
Set-up dedicated timelines with ad-hoc calculator describing key actions & timelines for each contributor.
Management of internal communication & Interactions with the contributors to follow the SCP final dossiers preparations:
Follows up the dossier preparation to identify when a submission is at risk and liaises with Stakeholders to solve any issues till HA submission.
Follows up the final SCP preparation and identifies missing key documents for deferred action countries submissions and liaises with Stakeholders to ensure proper provision of documents is available.
Administrative & digital regulatory activities
Including coordination of administrative and regulatory activities related to administrative changes, Marketing Authorisation Transfer (MAT), Orphan Drug Designation (ODD), Pediatric Investigational Plan (PIP) and RPI (Research Product Identification) transfers:
Set up KOM with stakeholders
Coordination with contributors
Prepare and customize final dossier SCP structure, upload administrative supportive documents, assign metadata and approve
Proposal for common VV data entry
Preparation of administrative documents: Cover letter, eAF via PLM if applicable
Create, review & track the IRIS submissions if applicable.
Non-core regulatory activities
• Applying simplification of the end-to-end processes leading to limit contribution of RS and affiliates and retrieve information from regulatory database and regional regulations
• Maintenance and improvements of the current regulatory repositories already in place
• Ensures with contributors the process compliance and timeliness.
• Enter associated data into Sanofi systems as required by internal SOPs and policies (#BeDataReady) in case of EU-Platform coordination and/or restricted access for EU deferred countries
• Participate to the preparation and update of quality document, processes, tool enhancement and training materials pertaining to role.
• Monitor KPI’s by running reports, collating data and report as per oversight and governance process.
• Using regulatory business data knowledge, understanding of system data model(s) and technical skills, analysis requirements and specifications for regional regulatory information, reports, and analytics.
Experience:
1 + year experience within an EU regulatory affairs department in a global pharmaceutical company
• Experience with multifunctional and multicultural organizations
• Experience with the management of activities requiring short to long term planning and monitoring ability
• Experience working in a highly matrixed organization
Comprehensive knowledge and operational expertise of the EU regulations and procedures
Understanding of change management in the pharmaceutical area and EMA vision of digital interfaces
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
Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs
Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science
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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Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!