Regulatory Planning Specialist

Job description

Our position 

Job title: Regulatory Planning Specialist  

Location: Budapest, Hungary

Flexible working : 60% home, 40% office 

Job type: Permanent, full-time 

About the job 

Our team:

The Planning, Capacity Management, Metrics Lead Regulatory Planning Specialist integrates 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. 

The incumbent uses R&D and GRA planning tools to plan growth driver activities and creates strategic resource scenario forecasts for the GRA Leadership Team to allocate resources within budget. 

About Growing with us 

Main responsibilities:

·  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 & PROVIEW 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. 

About you  

·  Experience :

·  Experienced in the pharmaceutical industry, with direct regulatory affairs experience and/or project management in a global and matrix environment preferentially in R&D.
·  Experience in registration, submissions for EU, US, Japan or China with regulatory lifecycle marketing authorisation experience is preferred.
·  Development and planning experience is desirable,  mapping skills would be desirable.
·  Appetite for planning tool and planning management, first experience in Planisware would be a plus.

·  Soft Skills:

·  Experience in Stakeholder management and Project management.
·  Highly organized: able to multi-task (i.e., work on several initiatives at same time). 
·  Ability to participate in multi-disciplinary and diverse teams and interface. Ability to communicate and collaborate on many levels, including issue escalation to leadership.
·  Ability to work across cultures with strong interpersonal skills to be effective in global teams with customer focus and action orientation.
·  Strong organizational and communication skills.
·  Ability to travel at minimum level (domestic and/or international travel up to 10%) .
·  Ability to maintain discretion and confidentiality about sensitive data.

·  Technical skills :
·  Planning, MS Project or equivalent packages.
·  Regulatory data and or analytical  reporting skills such as Power BI, Data visualisation skills would be an advantage.

·  Education : 

·  BSc in Regulatory affairs, Life Sciences, or related areas of study or equivalent or project management centred on drug development or scientific studies project management.

·  Languages :

·  Excellent written and verbal communication skills in English.

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.

#Sanofi

#WeNeverSettle       

#SanofiCareers            

#joinsanofi

#careerswithpurpose

#SBSBUDAPEST

#GRA

#pursueprogress

#discoverextraordinary

 

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.