Teva Senior Expert Regulatory Affairs Bulgaria, Sofia 647730281
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• 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
• Dynamic and challenging work environment in one of the world leading pharmaceutical company and the biggest pharmaceutical company in Bulgaria
• Competitive remuneration bound with performance
• Additional healthcare insurance
• Transportation allowance and other flexible benefits according to the company policy
• Flexible working hours and option to work from home as per the company policy
• Opportunity for development
Please, kindly note that only shortlisted applicants will be contacted. All personal data is protected by law and will be treated in confidence.
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