Regulatory Affairs Manager

Regulatory Affairs Manager

Teva

Bucharest, Romania

The Role:

The Regulatory Affairs Manager has the responsibility of obtaining and maintaining marketing authorizations, by providing regulatory expertise, for EU and Romanian market.

Main responsibilities:

  • Support on the strategies and registration procedures to follow for the submission of Marketing Authorizations (MA) for Teva portfolio products
  • Submissions dossier preparation with all national information required, (local review, cover letters, applications forms, fees payment, etc.)
  • Submission and execution of national applications and national variations to local regulatory Authorities for MAs.
  • Translation of job-specific documents (leaflet, summary of product characteristics -SmPC, labels and other documents) from Romanian to English and English to Romanian.
  • Prepare the artworks for the company's products.
  • Communication with local authorities on specific topics/projects, if needed
  • Good knowledge on local and EU legislation. Input for global development projects and due diligences. Keep informed about local legislation and changes in the regulatory environment
  • Assist and provide necessary documents during audits and inspections of affiliates including distributors/vendors/3rd party
  • Actively interact and provide information, support and advice to Teva’s internal departments/affiliates and clients on technical and regulatory issues concerning registration or post-approval change documents
  • Review for regulatory compliance the analytical validation, stability or other protocols with regulatory or compliance impact

Main requirements:

  • University degree, ideally in Pharmacy, Chemistry, Biology, Biochemistry or in other area, but pertinent with the field
  • Preferably 3- 5 years of experience in the multinational pharmaceutical companies as Regulatory Affairs Associate or Regulatory Affairs Manager
  • Good communication skills (both written and verbal English) and interpersonal skills
  • Organized with good time management skills
  • Pro-active and result oriented
  • Able to adapt and respond to internal (e.g. priorities) and external (e.g. regulatory environment) change
  • Must have an eye for detail and a methodical approach to work
  • Computer literacy(MS Excel, MS PowerPoint, etc.).. Must be experienced in the use of spread sheet and word-processing programs. Understanding of regulatory tracking databases

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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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