Experience

Wörwag Pharma GmbH & Co. KG

• Germany
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• • Sep 2019 - Present

  Regulatory- Regulatory preparation/submissions of any kind of EU procedures;-Providing Regulatory strategies of all upcoming company's projects;- Translations of product information-Revision and approval of packaging materials-Communication with local Health authorities-Revision of promotional materials-Supports other departments and Launch Manager with regulatory input-Budgeting- CESP submissionsQuality Assurance-Oversee the implementation and maintenance of Quality Management System of the company to be in compliance with regulatory requirements as applicable including CAPAs, Complaints, Validation, Audits, and Training; -Working cross-functionally with QA manager and other functions to assure implementation, use, maintenance and alignment of Quality Compliance programs across the company; -Managing Company document system ensuring its maintenance and update; -Cooperating with different company functions; Support and oversee on a quality compliance perspective, electronic system implementations, validation and lifecycles; -Oversee the products’ quality defects and recalls; -Oversee QA manager.Pharmacovigilance-Managе the maintainance and improvement of the Pharmacovigilance System in Bulgaria according to BG and EU PV legislation as well as the Company's standards; -Oversee the activities of PV team related to collecting, recording, reporting and follow-up of all suspected adverse reactions (reportable cases according to GVP Module VI); -Manage and participate in pharmacovigilance audits and inspections; -Creation/ updates of local SOPs; -Organize trainings of the staff in PV and applicable SOPs according to EU/ local legislation. Show less

• • Sep 2012 - Present

  -New submissions and life-cycle management-Translations of product information-Revision and approval of packaging materials-Communication with local Health authorities-Revision of promotional materials-Supports other departments and Launch Manager with regulatory input-Budgeting

• • Oct 2018 - Sep 2019

  Regulatory Affairs Manager- New submissions and life-cycle management of medicinal products- Managing documentation/ launch processes of food supplements- Translations of product information- Revision and approval of packaging materials- Communication with local Health authorities- Revision of promotional materials- Supports other departments and Launch Manager with regulatory input- BudgetingDeputy Local Pharmacovigilance Manager- Maintains and improves the Pharmacovigilance System in Bulgaria according to BG and EU PV legislation as well as the Company's standards- Collect, record, report and follow-up all suspected adverse reactions (reportable cases accordingly GVP Module VI) in Bulgaria- Acts as a deputy of the single point of contact for the authorities on a 24-hour basis- Participates in pharmacovigilance audits and inspections- Oversees the safety profiles of the company’s marketed products and any emerging safety concerns, including products’ quality defects and recalls- Creation/updates of local SOPs- Training the staff in Pharmacovigilance and applicable SOPs according to EU/ local legislation - Budgeting Show less



Sopharma

• Bulgaria
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• • Nov 2007 - Sep 2012

  Preparation and submission of documentation for registration/ renewal/ variation procedures of the drug products and food supplements in EU and non-EU countries

• • Jul 2007 - Nov 2007

  - Collect and evaluate data for inclusion in marketing authorization dossiers (Module 3); review for regulatory compliance the specifications, analytical validation, manufacturers, stability or other protocols with regulatory impact; - Support R&D department on different topics around supporting data requirements in alignement with Health Authorities’;- Compile dossiers (Module 3 and corresponding QoS) for presentation to regulatory authorities, following the current or new requirements;- Review for regulatory compliance the Active Substance Master Files and ensure that the documentation of the active substance is appropriate for the submission;- Support internal file quality evaluation processes and coordinate remedial activities- Respond to deficiency questions (from Regulatory Authorities) concerning dossiers submission or changes - manage the process to respond to the CMC questions;- Prepare the post-approval submission packages (incl. variations, renewals and etc.) and other necessary documents as required by the regulatory post-approval processes. Show less