Lead Regulatory Affairs Associate

Lead Regulatory Affairs Associate

Teva

Zagreb, Croatia

Job description

In your new role you will be working remotely from Croatia for US market on reviews and submit high quality, right first time regulatory submissions (complex ANDAs, 505(b)(2)s, amendments, supplements, annual reports) to the FDA.

  • evaluating change controls and providing regulatory assessment within the company system to regulatory documents and formulate strategies with minimal guidance, to ensure proper filing categories;
  • compilation and review of high quality submissions (ANDAs/NDAs, amendments, supplements, annual reports, etc.);
  • drafting ANDA/NDA modules for original applications, amendments, supplements, etc., for FDA submission;
  • drafting deficiency letter responses and coordinating cross functionally (internally and externally) to obtain accurate documentation;
  • leading Right First Time Submissions (including ANDAs/NDAs, amendments, supplements, etc.);
  • maintaining full awareness of all regulatory activities on assigned projects and ensure that the project deadlines and performance standards for these projects are established and met;
  • working with internal and external stakeholders to manage submission schedules;
  • updating tracking sheets and managing change control.

Qualifications

  • University degree - Chemistry, Chemical technology, Pharmacy or other related field;
  • minimum 4 years of relevant EU/international Regulatory Affairs experience, desirable in registration of sterile products on US market;
  • we will also consider candidates with less experience than mentioned;
  • prior collaboration with FDA, knowledge of ANDA fillings and combination product experience is preferred;
  • excellent English in speech and writing;
  • detailed and systematic approach.

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© EuroJobsites 2022

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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