Regional Regulatory Affairs Manager

Posted 25 Mar 2020

Mazowieckie - all, Mazowieckie - Poland

Req Id 204684

Details

A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your Role:

As a Regional Regulatory Affairs Manager, you will oversee and coordinate project for the region on a Therapeutic Area Basis.  You will monitor pipeline and development programs, drive capacity requirements and plan and coordinate resourcing capacity for upcoming submissions. You will be responsible for planning scope for HA interaction and reg intelligence and preparing and conducting country roll out by supporting dossier management and document translations. You will act as point of contact for dossier compilation to ensure ready to submit dossier is available as per agreed plan. Within your scope will be conducting internal training on promotional materials and providing relevant support for clinical trials as applicable. You will provide appropriate levels of support, coaching and tools to the team, drive regional strategy cross-functionally for roll outs and  serve as internal point of contact for TA specific questions and requirements. You will infuse regulatory applications/documentation (dossier, promotional material) and manage PSP, IST for marketed products & support management of critical HA notifications e.g. review & document impact of incidents.

Who you are:

  • University degree (Master, PhD) in pharmaceutical science or an equivalent qualification with relevant work experiences
  • 3-5+ years of experience in the regulatory affairs field
  • At least 2 years of supervisory/ managerial experience is preferred.
  • Demonstrated analytical & strategic skills & high affinity to managing/coordinating End to End projects and activities
  • Proven ability of communication and collaboration with stakeholders from different
    backgrounds/functions
  • High proficiency in English is a must, knowledge of additional foreign language will be an asset
  • Flexibility and willingness for business trips

 


What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

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