Experience

Wörwag Pharma GmbH & Co. KG

• Germany
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Regulatory Affairs Specialist

  • Jul 2021 - Present



Adipharm EAD

• 1 - 100 Employee

• Regulatory Affairs Specialist

  • Nov 2018 - Jul 2021

  - Responsible for registration and post-registration strategy for a portfolio of 15 commercial pharmaceutical products (Bulgaria, Ukraine, Azerbaijan, Iraq, Vietnam, Qatar, Saudi Arabia). - Preparing documentation for new products registration. Prepare and verify module 3 in base of documents and report from QC department and quality part of module 2, coordinate Collect all the documents and prepare module 1 from product dossier. Coordinates the preparation of all clinical and non-clinical reports as well as the preparation of the RMP of the drug product. - Preparing labelling and ensuring that mock-ups are according to the current legislation. - Preparing of eCTD dossiers for submission Regulatory Agency. - Critical evaluation of post-registration changes in order to prepare the dossier and ensure the submission based on strategy for fast approvals (variation, renewal). Prepare and verify all needed documents for renewal. Coordinates the preparation of all clinical and non-clinical addendum as well as the preparation of the PSUR of the drug product. - Prepares and verifies the product variation documents (addition of a new place of manufacture; addition / replacement of manufacturer of an active substance; change in composition of finish product and etc.). strong knowledge of CMC and successful edition of Modules 3 in eCTD format; specific experience in the registration of Generics Drug Product ; knowledge of EMA, ICH and FDA regulations, guidances, and regulatory processes pertaining to drug development, approval, and maintenance of marketing authorizations; fluent in English spoken and written.



Respiron East Europe LTD.

• Bulgaria

• Customer service and Regulatory affairs expert.

  • Jan 2016 - Nov 2018



Scortel

• 1 - 100 Employee

• Office Coordinator,

  • Jun 2007 - Dec 2015



Executive Agency Military Clubs And Information

• Junior expert

  • Mar 2005 - May 2006