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TEVA is looking for qualified candidate for the position of Regulatory Affairs Manager based in Sofia.

Main responsibilities

  1. Planning, preparing, and submitting post-approval variations in line with the corporate procedures.
  2. Organizing and supervising the training of new employees on all relevant SOPs and WI.
  3. Supervising the working process for new employees.
  4. Handling complex projects, requiring a high level of technical expertise and project management skills.
  5. Maintaining the relevant regulatory tools.
  6. Keeping up to date with regulatory legislation.
  7. Maintaining communication pathways with all relevant internal stakeholders and external contacts DRA, Local Affiliates, Business Development, Contract Management, IP, Marketing, Core Teams, and Portfolio.
  8. Manufacturing sites, QC, Authorities, consultants, etc.

Main requirements

  • MSc/PhD in Life Science, Pharmaceutical or equivalent university degree;
  • Experience in regulatory or pharmaceutical industry;
  • Solution and result oriented attitude;
  • Good organizational and good communication skills;
  • High level of written and spoken English.

The Offer

  • Team spirit and multinational working environment;
  • Trainings and career development opportunities;
  • Compensation linked to performance and experience, benefits;
  • High-tech working conditions and modern office space.