Regulatory Affairs Manager

Regulatory Affairs Manager

Teva

Sofia, Bulgaria

Teva local Regulatory Affairs department is looking to recruit Regulatory Affairs Manager to take responsibility for assigned marketing authorizations of Teva portfolio. The position reports to and acts as substitute for the local RA lead.

Main duties and responsibilities:

  • Timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the competent authorities;
  • Maintenance of assigned authorized products through timely submission of variations and renewal applications;
  • Timely, accurate and compliant labeling updates and artwork preparation;
  • Designing and implementing regulatory strategy and ad-hoc local action plans, as necessary;
  • Joint work with Business Development, Medical department, Business Units, Quality and Logistics, locally, regionally and globally, to support business initiatives in the region.

Successful candidates should have:

  • Degree or equivalent - MS degree in pharmacy or other life science;
  • A minimum of 6 year experience in a Regulatory Affairs department or equivalent, which should include dealing directly with Regulatory Agencies with most aspects of drug registration;
  • Excellent understanding of local and EU legislation, procedures and guidelines governing pharmaceutical products;
  • Meticulous attention to detail and ability to work independently;
  • Good organizational and planning skills, ability to communicate well verbally and in writing;
  • Ability to take responsibility and solve complex problems, flexibility to successfully handle conflicting time pressures;
  • Proficiency in local and English language as well as PC use with regard to word-processing, spreadsheets, database applications, and internet.

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© EuroJobsites 2018

EuroJobsites is a UK 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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