Global R&D - Senior Regulatory Affairs Manager

Global R&D - Senior Regulatory Affairs Manager

Galderma

Uppsala, Sweden

About the role

As Senior Regulatory Affairs Manager you will represent Regulatory Affairs as Regulatory Lead in key development and life cycle management projects. You will be responsible for co-ordination and dossier compilation. The role also includes managing Life Cycle Management activities including variations, renewals, labelling changes etc.

Your responsibilities would include

  • Act as Global Regulatory lead within multi-functional project teams, provide support and influence decision-making in order to enable project delivery within defined targets;
  • Analyze regulatory requirements and develop regulatory strategies world-wide, including active communication with local Regulatory Authorities and Galderma affiliates;
  • Deliver high quality regulatory documentation for all activities either Development projects or Life Cycle Management Projects;
  • Represent Regulatory Affairs in internal and external audits;
  • Geographical Expansion of the portfolio;
  • License maintenance;
  • Surveillance of regulatory requirements - at Global level.

MINIMUM REQUIREMENTS

ABOUT YOU

  • You hold a university degree in a life science area such as Pharmaceutical Science or similar;
  • You also have several years’ experience of Regulatory Affairs within the Pharmaceutical or Medical Device industry, or from an Authority (Health authority, Notified Body or similar) perspective;
  • You have experience of compiling and reviewing documents/reports according to Global regulatory guidelines;
  • You are open-minded and willing to adapt to changes and enjoy working with others in a collaborative way, also across several cultures;
  • 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.

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© EuroJobsites 2021

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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