Global Regulatory Affairs Manager

Global Regulatory Affairs Manager

TFS

Stockholm, Sweden

They key responsibilities include:

  • Regulatory responsible for the company's and/or partner Products;
  • Responsible for coordinating and submitting applications and post-marketing obligations to the authorities;
  • Be an expert on processes, applications and regulatory environment to achieve and maintain marketing authorizations;
  • Provide generalist comments on the content of regulatory applications;
  • Be regulatory representative in the Core Projects/Products Teams, if applicable;
  • Cooperate with authorities, partners, regulatory consultants and other departments within the company;
  • Develop and update regulatory SOPs;
  • Provide regulatory input to project and product forecasts.

Requirements:

  • Degree in Life Sciences;
  • Experience from pharmaceutical industry or competent authority (registration, development, maintenance);
  • Preferably more than 3 years of experience from pharmaceutical industry or competent authority (registration, development, maintenance). Experience working with several European countries is an advantage;
  • Regulatory Affairs knowledge;
  • Fluency in Swedish, English, other languages is an upside but not require;
  • Strong team-player with collaborative, respectful and flexible attitude and high engagement;
  • Interest of alliance management;
  • Good communication skills.

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© EuroJobsites 2019

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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