Regulatory Affairs Manager

Regulatory Affairs Manager

Galderma

Uppsala, Sweden

Description

The Regulatory Affairs Department at Galderma Uppsala is responsible for all Regulatory aspects of Galderma’s aesthetic business at Global level. This includes new product registrations, line extensions and Life Cycle Management of the portfolio of products for both Pharmaceuticals and Medical Device.

We are now looking for a Regulatory Affairs Manager to join the Medical Device RA team in Uppsala for a fixed term contract of 18 months.

About the role

The role will offer an opportunity to work with development and line extension projects for the Medical Device portfolio of products. You will be responsible for dossier compilation, submissions, manage variations and represent Regulatory Affairs in different teams.

Your responsibilities:

  • Marketing applications for new products at Global level;
  • License maintenance;
  • Coordinate submissions and related responses to questions to Regulatory Authorities;
  • Surveillance of regulatory requirements at Global level.

About you

  • You hold a university degree in a life science area such as Pharmaceutical Science or similar.
  • Experience of compiling and reviewing documents/reports according to regulatory guidelines and/or experience of a similar role in a Pharmaceutical or Medical Device environment, would be considered a merit.
  • You are open-minded and willing to adapt to changes and enjoy working with others, across cultures, in cross-functional and collaborative ways
  • You are self-driven, flexible, methodical, with the ability to structure work and manage multiple requests while maintaining timelines
  • You possess good communication skills and fluency in Swedish and English, both verbal and written. Strong writing, reading and reviewing skills are necessary.

Apply Now

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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