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Regulatory Affairs Manager (M/F)

Posted 18 May 2018

Bourgogne - all, Bourgogne - France

Req Id 176437

Details

A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 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 :

 

You will be responsible for dossier compilation and life cycle management activities such as CMC and labelling for a defined product portfolio including medicines, devices and food supplements.  You will liaise with functional experts and country regulatory managers to plan and deliver compliance activities within agreed timelines.  Responsibilities include assessment of change controls, definition of dossier requirements to maintain compliance depending on the product status, preparation and publishing of dossiers, e.g. for variations, renewals and safety reporting, and maintenance of information in relevant databases.  You will also support the assessment and preparation of dossiers for roll out of products into new countries depending on business decisions.  You will assess and advise on regulatory risks and make recommendations to resolve problems or issues, by using judgment that is consistent with standards, practices, policies, regulation or guidance from governmental bodies.

Position based in Dijon France (21) or Paris.

Please send your application in English.

 

Who you are :

  • Life sciences degree (Pharmacist, or Master in regulatory affairs) with 4+ years of experience in Regulatory Affairs with knowledge of EU regulatory frameworks.
  • Medicines, Medical Devices and Food Supplements knowledge essential. Familiarity with Traditional Herbal Medicinal Products, Biocides, Cosmetics beneficial.
  • Excellent interpersonal skills and the ability to work in a collaborative manner in a multicultural, multinational, matrix environment.
  • Strong organizational skills, attention to detail and a commitment to quality
  • French and English fluent

What we offer: 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!

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