Regulatory Affairs Senior Specialist

Regulatory Affairs Senior Specialist

Teva

Milan, Italy

 

Job Description

The person has the responsibility of supporting the Site in obtaining marketing authorization for Growth markets (including the first submission), for EU (from the second submission on) and maintaining marketing authorizations (for GM, EU, US), by providing regulatory expertise and support in order to avoid any production disruptions thus bringing and keeping each product on the market. She/he maintains the dossiers in order to reflect the latest regulatory status. Actively participate to the improvement or at least maintenance of the compliance status of the site.

Main responsabilies:

  • Achieve and maintain marketing authorizations in target countries
  • Contribute to regulatory lifecycle management
  • Preparation of Annual report package also including the 1.13.5 Index and 1.13.5 Summary of Changes compilation for US market according to US-RA process
  • Actively interact and provide information, support and advice to Teva’ internal departments/affiliates on technical and regulatory issues concerning registration or post-approval change documents.

Qualifications

  • Scientific degree, preferably gained in CTF
  • At least more than 5 years of experience in pharmaceutical regulatory affairs
  • Master in “Regulatory Disciplines” would be preferred
  • Accurate and fast acting
  • Good communication skills (both written and verbal) and interpersonal skills
  • Organized with good time management and decision making skills
  • Customer-oriented mindset
  • Pro-active and result oriented
  • Able to adapt and respond to internal (e.g. priorities) and external (e.g. regulatory environment) change.

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© EuroJobsites 2019

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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