Global Regulatory Planning Coordinator

Job title: Regulatory Planning Specialist
Location: Budapest, Hungary
Job type: Permanent, full-time
Hybrid working

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 our Regulatory Operational Planning & Capacity Management team (under Global Project and Planning Management) as a Regulatory Planning Specialist and you'll be managing regulatory plans of Sanofi R&D Pharma & Vaccines projects. You'll have the opportunity to work together with many departments on a global level.

Main responsibilities:

Owner of the operational planning of several Pharma & Vaccines projects for all regulatory activities, whatever their location.
Ensures the project strategy is reflected in terms of Planning into the operational plan. Is accountable for the customization of the operational plan with the most known information.
Is accountable of a rolling update of the activities under their functional perimeter
Is an active member of the Monthly Project Planning Review meeting with other Planning actors, sharing news on planning/execution and highlighting potential risks/impacts
Analyzes the project deliverable timelines and critical path activities.
Works closely with all Planning actors (CSO, TMU, CMC OPCMs and PPM) for anticipating and identifying any deviation and alerting key OPCM interfaces in case of major events having an impact on project milestones and proposes recommendations / facilitates decision making.
Supports impact management by making analyses and assessing planning scenarios with project and planning actors.
Is active contributor of the Program Financial Valorization exercise for Governance decision by creating appropriate scenarios in the project portfolio management tool.
Once agreed with Project actors, OPCM is the single accountable person for the accuracy of the plan entered and its customization in the planning tool. He/she ensures history data follow-up in the planning tool and coordinates quality controls of Planning data.
Communicates the updates to the appropriate stakeholders as well as any report (e.g., Gantt chart) supporting decision management.
Provides reporting and analysis to support the project team and GRA operational teams, including during project (sub) team meetings.
Leads, supports, implements and communicate the operational planning standards / templates improvement (Libraries of activities) in the RDPM planning tool as well as the development of the quality checks.
Participates in any user requirement definition &/or testing for new reports & upgrades of existing ones
Leads &/or represents OPCM in any initiative aiming at improving, simplifying or automating planning updates & OPCM ways of working, such as process definition & maintenance of processes, planning best practices, etc.
Represents Regulatory OPCM in Master Data Management (MDM) topics such as in study coding & tool enhancement.

About you
Experience:

General knowledge on overall R&D Drug Development and good knowledge in Business operational activities (Regulatory)
Good knowledge of Project Management
Strong knowledge in planning management

Soft Skills:

Rigor, Analytical skills and spirit of synthesis, Quality orientation
Excellent organizational skills, rigor, striving for results, high accuracy orientated
Strong communication skills and interpersonal relationship demonstrated
Excellent presentation skills (verbal and written)
Strong Networking skills
Creative problem-solving skills

Technical skills:

Good computers skills
Knowledge of planning tool (Gantt chart)

Education:
Minimum master in a scientific degree and / or regulatory affairs

Language(s):
Strong English skills (verbal and written), ability to exchange fluently in a global environment

Why choose us?

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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