Our position

• Job title: Regulatory Renewal Coordinator
• Location: Budapest, Hungary
• Flexible working: 60% home, 40% office
• Job type: Permanent, Full-time

About the job

Our Team:

The renewals team is responsible for ensuring Sanofi drugs continuity on the market to serve our patients health. The Renewal coordinator ensures timely maintenance of the Renewal Reference Plan, Renewal submission process initiation in line with regulatory requirements, coordination of the renewal preparation workflow with stakeholders.

High attention to details is needed due to large data to be managed in the Reference Renewal Plan. The incumbent will interact closely with all colleagues contributing to Renewals submission completion, to ensure high quality Renewal dossier is submitted in accordance with timelines and contributing to reach the KPI.

The Regulatory Renewal Coordinator has the primary accountability for the Reference Renewal Plan preparation and maintenance. He / She ensures submission or dispatch of Renewal dossiers of high quality and according to timeliness defined in the Renewal Reference Plan.

This role is responsible to ensure implementation of Renewal process improvements and development/update of the appropriate digital tools aligned with Global Regulator Affairs (GRA) Global strategy.

Main responsibilities:

• Ensure submission of renewal dossiers to Health Authorities and dispatch to stakeholders in collaboration with Affiliates / Distributors and Regions and GRA Ops Submission teams.
• Propose Renewal processes simplification to Renewal Process Owner, whenever harmonization and simplification is needed.
• Prepare and maintain the Renewal Reference Plan (RRP) for worldwide registered products in the scope and ensure implementation of processes and support effective change management communications.
• Represent Submission management team as Regulatory Renewal Coordinator and SME to provide efficient support to internal stakeholders and external teams on renewal activities.
• Contribute to meetings and workshops related to renewals initiatives & tools as well as development, production, maintenance and enhancements of the appropriate tools and reports for management of the renewal’s dossier.
• Collaborate with stakeholders to understand the global regulatory environment for Sanofi business needs and propose to Renewal Process Owner appropriate action plans for Renewal preparation and submission.
• Participate to the writing and review of quality documents related to renewals and produce and keep up to date Renewal training materials.
• Collaborate with external vendors to support renewal preparation & submission as well as perform KPI calculation for renewals submissions to ensure the right input into 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 products license requirements.

• Soft skills:
  

• Competencies in communication with several stakeholders (RA affiliates, GRA regions, Product Leads, contributors – Submission Management team, Global Pharmacovigilance, labeling, etc.)
• Capability in coaching and guiding stakeholders to preparing accurate and reliable planning.
• Ability to organize/prioritize work assignments and projects independently and deal with conflicting priorities in constantly changing environment.
• Ability to work in a matrix international environment with cross-functional teams.
• Excellent coordination skills across several contributors to reach high quality and in time submissions.
• Project Management skills, such as planning.
• Very good communication, negotiation, and facilitation skills.
  

• Technical skills:
  

• Knowledge in management of data in databases and working in workspace such as Document Management Systems (e.g. VAULT RIM or related).
• Proficient in the use of MS WORD, PowerPoint, Excel, Adobe Acrobat and the use of collaborative work environment tools (e.g. SharePoint, TEAMS).
  

• Education:
  

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

• Languages:
  

• With strong command of English (written and spoken) to support efficient decision-making.

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.

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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