EU Regulatory Coordinator
Job title: EU Regulatory Coordinator
Location: Budapest, Hungary
Flexible working: 60% home, 40% office
Job type: Permanent, full-time
About the job
We are currently on a journey where we are transforming how we support our Global Regulatory Affairs (GRA) teams and are looking for team members who can join us on this exciting journey.
Sanofi Global Regulatory Affairs is looking for an EU Regulatory Coordinator to join their team to execute European regulatory related activities in support of the development and maintenance of Sanofi products for EU dossiers preparations & others key regulatory activities. The EU Regulatory Coordinator team member will be part of EU-Platform team and will be in permanent interactions with the regulatory strategists to support them.
The successful candidate for this role is driven to do something meaningful and having impact on people’s health and well-being. The Sanofi Global Regulatory Affairs EU Regulatory Coordinator/ will be a critical member of a highly productive team, a collaborative team player, and driven to problem solve and simplify ways of working.
- Deliver key start and follow-up of submissions Initial/Health Authority (HA) Request for Supplementary Information as per plan/requests for Sanofi products submitted by European procedures (including Worksharing - Mutual Recognition Procedure(MRP)/Decentralized Procedures(DP)-CPs):
- Concerning the preparation of non-core activities for HAs submissions as per plan and Health Authorities requests.
- Set up kick of meeting with the EU Regulatory strategists and start the non-core activities.
- Interactions with the stakeholders to follow the 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.
- Applying simplification of the processes of end-to-end processes leading to reduce the involvement at affiliates level for national submission & Retrieves information from Regulatory database and EU regulations to limit contribution of EU Regulatory strategists.
- Centralization of regulatory activities for Sanofi products by using digital tools to support the preparation of the non-core activities in Europe: management of the updates and follow-up via EMA IRIS Portal.
- Maintenance and improvements of the current EU regulatory Repositories already in place.
- Ensures together with contributors the process compliance and timeliness.
- Enter associated data into Sanofi systems required by internal SOPs and policies (#BeDataReady).
- Maintain regulatory requirements database.
- Participate to the preparation / 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.
- Ensure on time completion of own tasks.
- Using Regulatory business data knowledge, understanding of system data model(s) and technical skills, analysis requirements and specifications for EU Regulatory information, reports, and analytics.
Knowledge, Skills & Competencies:
- Experience within an EU regulatory affairs department in a global pharmaceutical company and knowledge and operational experience of EU regulations is desirable.
- Understanding of the relationship between systems and electronic databases.
- Understanding of eCTD dossier requirements. Local authority will be considered too.
- Understanding of change management in the pharmaceutical area, ideally for labeling changes and EMA vision of digital interfaces as well as tracking of regulatory activities in corporate database.
- Soft skills:
- Excellent verbal, written, organizational and interpersonal skills with a sharp attention to detail and the ability to handle multiple tasks simultaneously.
- Established ability to problem solve user issues. Demonstrates critical thinking.
- Collaborative team player with orientation towards building and maintaining effective relationships, strong culture awareness.
- Ability to work under pressure, adaptability to change, solve problems and willingness to learn to drive to meet short deadlines and shifting priorities.
- Ability to embrace new activities and willingness to learn and to work with multifunctional and multicultural teams with high number of partners.
- Technical skills:
- Working knowledge in Microsoft Office and Windows (Outlook, Word, Excel, PowerPoint), web skills a plus.
- Hands-on knowledge of Veeva Vault tools is a plus.
- Project management and/or coordination experience is a plus.
- Bachelor’s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study, and relevant experience, or bachelor’s degree or equivalent in project management centered on drug development or scientific studies project management.
- Excellent written and verbal communication skills in English; basic knowledge in French is desirable.
When joining our team, you will experience:
- An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
- An attractive, market-oriented salary and cafeteria benefits.
- Flexible home office policy, with a possibility to work up to 60% of time from home / where you can easily schedule your office days.
- Work from an "Office of the Year 2020" finalist office.
- Collective life and accident insurance.
- Yearly medical check-up.
- 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.
- Your own career path within Sanofi. Your professional and personal development will be supported purposefully.
- Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs).
Pursue progress. Discover extraordinary.
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, gender identity or Veteran status.
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.