Regulatory and Pharmacovigilance Specialist

Exeltis İlaç

Who we are looking for Regulatory and Market Access Specialist:

• Bachelor’s degree or equivalent in pharmacy or related scientific discipline from reputable universities
• Minimum of 3 years experience in Pharmaceutical sector
• Experience in pricing and reimbursement
• Experience in food supplements /medical devices is an asset

İŞ TANIMI

 

• Prepare and submit applications for marketing authorizations and coordinate all related activities, respecting the deadline in terms of launch timelines of the products Analysing and Managament of New projects & Available projectsGive support to Global HQ and related departments on every matter related to Regulatory knowledge and procedures,
• CTD preparations, applications and tracking
• MA transfers, MA renewals
• Market Access Processes
• GMP dossier preparations, applications and tracking
• Supporting of Pricing & Reimbursement Management
• Variations (tip IA, IB, II, safety)
• SPC & PIL/IFU – Preparation, translation & revision
• Food supplements (registration, packaging approval, importation process)
• Medical devices & Cosmetics (registration, packaging approval, importation process)
• Labelling (Artwork studies for all products)
• Pharmacovigilance Responsibility (Training, DRA tracking, agreements, export countries management)