Athens Metropolitan Area
Experienced Regulatory Affairs Manager with a demonstrated extended experience in pharma industry. Skilled in Pharmaceutics, Hematology, Oncology, Pharmacovigilance and Biotechnology. SME in new commercial launches/soft launches as per regulatory sciences. Knowledge of Market Access procedures add value to profile. Strong legal professional with a Bachelor of Science focused in Biology from Panepistimion Patron and a MSc in Management, Health Care sector.
- Define processes to provide regulatory/PV support to all medical company activities across MCO (Multi-Country Organisation) Local Operating Company' s (LOC' s). Ensure all plans are carried out following the highest quality standards and meeting all ethics, legal and regulatory guidelines. - Support local regulatory teams for MCO countries (Greece, Bulgaria, Romania, Bosnia & Herzegovina, Serbia & Montenegro) and develop local regulatory strategy for the company in respect to global alignment. -Provide regulatory input to the Business Development projects at MCO level. - Develop relationships with high-level regulators to facilitate positive communication regarding strategies and regulatory filings. - Participate in the designing and the development of the strategic plan. - Guarantee having necessary tools and IS-IT platforms to support activities ans assure a proper updating and maintenance of local and international databases. - Support local (Greek) regulatory and medical affairs department.