Group Leader Pillar Regulatory Affairs

Group Leader Pillar Regulatory Affairs

Teva

Zagreb, Croatia

Job Description

Managing a team of RA Associates that are responsible for compiling and maintaining the CMC part (modules 2 and 3) of medicinal product dossiers for the worldwide registrations of the products handled by the Site RA (SRA) Pillar team.

Roles & Responsibilities

  • plan Departmental activities, and ensure that they are adequately delegated and that the required resources are available. Directly coordinate and prioritize daily activities of the assigned staff;
  • supervise and coach SRA Associates in their duties and also handle the allocated portfolio, the main tasks being:
    • actively participate in the change control system and the RA strategy related to CMC changes;
    • actively participate to the improvement or at least maintenance of the compliance status of the dossiers;
    • keep track of the variation status and update the relevant departments accordingly;
    • be responsible for renewal/annual reports applications preparation;
    • maintaining the dossiers, in order to reflect the latest regulatory status;
    • providing answers to module 3 questions from Health Authorities, handling respective deficiency letters, supporting foreign representatives and 3rd parties and maintaining good contacts with external parties;
    • providing assistance in the technical transfer of products.
  • monitor and report on departmental Key Performance Indicators;
  • identifying process improvements and making proposals for their implementation;
  • representing Site Regulatory Affairs in (multi-disciplinary) project teams;
  • recruit staff as necessary;
  • ensure that all SRA Associates are adequately trained and well informed as to their role, duties and responsibilities.

Qualifications

  • University degree - Chemistry, Chemical technology, Pharmacy or other related field;
  • minimum 5 years of relevant EU/international Regulatory Affairs experience;
  • 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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