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. 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?

Join us as a Regulatory Planning Specialist and you will integrate Global Regulatory Affairs (GRA) portfolio planning for Research and Development (R&D) projects, and automated planning of submission milestones of lifecycle maintenance activities, with resource capacity management of headcount to provide accurate metrics. You will use R&D and GRA planning tools to plan growth driver activities and create strategic resource scenario forecasts for the GRA Leadership Team to allocate resources within budget.

• Second-line R&D Project Planning Management: Support Global Regulatory Teams (GRT) to define and operationally manage regulatory functional plans to ensure alignment, acceleration, and integration with overall R&D plans, leveraging R&D Planisware tool. Communicate with stakeholders (Global Regulatory Leads, Global Project Managers, or any relevant functions from Global Project Teams) on any planning issues and provide guidance on project planning alignment/optimization.
• Plan GRA deliverables for products or R&D projects under delegated responsibility, provide visual consolidated plans/extracts from RDPM upon stakeholder needs. Provide regular consolidated update/reporting/analyses to project team members.
• Manage periodic baselines processes for defined R&D portfolio to support business continuity and quality of plans for R&D projects. Maintain baseline calendar, run, remediation, communication to GRA stakeholders, contribution to data remediation upon stakeholder feedback. Provide ad-hoc support to Regulatory Portfolio Managers to update R&D planning tool. Contribute to process improvement and management of data quality for R&D portfolio.
• Ensure R&D Projects planning tool maintenance for GRA: Implement R&D Planisware tool updates and harmonization of planning capabilities (structure & links between activities), lead PRIME codes creation by producing monthly extract of requests, track production and provide ad-hoc support to GRA stakeholders and PPM team for unplanned PRIME coding needs. Maintain generic R&D GRA RDPM exports, revisions and updates upon stakeholders needs, consolidation of distribution lists and periodic distribution to stakeholders. Provide exports from RDPM & TABLEAU data on a regular basis upon stakeholder's requests.
• Support to team management: Coordination of team meeting, including archiving of required documents on team Sharepoint or any relevant area. Lead of global mailbox management: ensure regular cleaning, reattribution of pending tasks/e-mails, compliance with mailbox instructions. Ensure maintenance of key document for team coordination, including project repartition list. Contribute to Portfolio Planning team internal communication plan supporting document creations, presentations, or any relevant support to strengthen Sanofi colleague's knowledges about team processes and scope.

• Experience in the pharmaceutical industry, with direct regulatory affairs experience and/or project management.
  
• Experience in registration, submissions for EU/US/Japan or China. Regulatory lifecycle marketing authorisation experience is advantegous.
  

• Stakeholder and Project management.
  
• Strong organizational and communication skills with the ability to multi-task,communicate and collaborate on many levels, including issue escalation to leadership.
  
• Ability to participate in multi-disciplinary and diverse teams and interface, work across cultures with strong interpersonal skills to be effective in global teams with customer focus and action orientation.
  
• Ability to maintain discretion and confidentiality about sensitive data
  

• Planning, MS project or equivalent packages.
  
• Appetite for planning tool and planning management, first experience in Planisware would be a plus.
  
• Regulatory data and/or analytical reporting skills such as Power BI, Data visualisation skills would be an advantage.
  

• 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)