Expert Regulatory Affairs

Expert Regulatory Affairs

Teva

Sofia, Bulgaria

How you’ll spend your day

• Planning, preparing, submitting post-approval variations in line with the corporate procedures
• Provide input into regulatory strategies and process improvement/compliance activities within defined areas of scope
• Analyse regulatory issues and communicate with key stakeholders.
• Maintaining of the relevant regulatory tools
• Keeping up to date with regulatory legislation
• Maintaining communication pathways with all relevant internal stakeholders and external contacts Regulatory Affairs, Local Affiliates, Business Development, Contract Management, IP, Marketing, Core Teams, Portfolio, Manufacturing sites, QA, Authorities, consultants, etc.

Your experience and qualifications

• 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