Experience

Ewopharma

• Switzerland
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Regulatory Affairs Manager, Local Compliance Officer

  • Sep 2016 - Present



Omega Pharma, A Perrigo Company

• Belgium
• Manufacturing
• 700 & Above Employee

• Regulatory and PV Affairs Manager CZ & SK

  • Feb 2015 - Aug 2016



Reckitt

• United Kingdom
• Manufacturing
• 700 & Above Employee

• Senior Regulatory Affairs Associate, Eastern Europe

  • Sep 2010 - Jan 2015

  I am responsible for EEU and Adriatic non – EU Countries: Estonia, Latvia, Lithuania, Poland, Czech Rep, Slovakia, Hungary, Slovenia, Romania, Bulgaria, Croatia, Bosnia, Serbia, Greece, Cyprus. • Possessing knowledge and understanding of pharmaceutical regulations in EE and surrounding regions. Liaise directly with local HAs in the: process of obtaining and maintenance of pharmaceutical MA approvals & narcotics licenses, MA variations and renewals of existing licenses, PSUR reporting, Price and Reimbursement activities (new price submissions, regular referential prices resubmissions (IPR), reimbursement projects (RA support in compiling of the dossiers, liaising with local MoHs). • Monitoring of the local regulatory trends that will impact the marketability of company products and ensure that the company is aware of significant regulatory issues. Interactions within and across functional teams: commercial director, sales and finance unit, clinical and scientific unit, medical unit, PV unit and marketing department – copy clearance of all promotional materials • Management of external consultants to achieve common goals and objectives. Tracking of invoiced activities and invoices. Defining new potential MAHs in new territories. Management of regional regulatory budget, responsibility over invoices. • Everyday cooperation with the EU MAH based in the UK to help defining new regulatory strategies in EEU and support agreed regulatory strategy/tactics required to secure desired global positioning. Cooperation with CMC RA global team in the manufacturing site in the production of necessary regulatory and technical documentation to meet demands of national regulatory authorities. • Provide regulatory supports to activities related to SOPs & training programs and regulatory compliance in the areas of RA and PV. Provide local regulatory knowledge to support commercial activities such as product release, QA/QC functions, supply chain issues. CFCC raising. Show less



Baxter Biosciences

• QA associate

  • Feb 2010 - Sep 2010



Hameln r.d.s.

• Research & Analytical Methods Development Specialist

  • Jun 2009 - Feb 2010