TEVA is looking for qualified candidate for the position of Regulatory Affairs Manager based in Sofia.
- Planning, preparing, and submitting post-approval variations in line with the corporate procedures.
- Organizing and supervising the training of new employees on all relevant SOPs and WI.
- Supervising the working process for new employees.
- Handling complex projects, requiring a high level of technical expertise and project management skills.
- Maintaining the relevant regulatory tools.
- Keeping up to date with regulatory legislation.
- Maintaining communication pathways with all relevant internal stakeholders and external contacts DRA, Local Affiliates, Business Development, Contract Management, IP, Marketing, Core Teams, and Portfolio.
- Manufacturing sites, QC, Authorities, consultants, etc.
- 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.
- 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.