Experience

Farmaprojects

• Spain
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Manager

  • Jun 2013 - Present

  - Start-up of Regulatory Affairs Department - Scheduling of activities for the team and delegate tasks /assignments to direct reports and monitoring of their realization, prioritize tasks/ assignments- Execution of fulfilments of key milestones, timelines and ensure quality of the work (in line with current legislations, procedures and internal agreements)- Cooperation with other departments / units within the structure of company and its external partners (including customers) and Health Authorities in the countries of the area of responsibility- Registration strategy planning- Budgeting and forecasting- Supervision of National submissions as well as DCPs, MRPs in both eCTD and NeeS- Supervision of maintenance of the approved Marketing Authorizations (lifecycle management)- Communication with Health Authorities- Regulatory support to Sales, Marketing, Manufacturing, Supply and other areas- Interactive liaison within the company, partner companies, external manufacturers and suppliers for all regulatory inquiries



ASPHALION

• Spain
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Regulatory Affairs Senior Specialist

  • Mar 2013 - May 2013

  - Due-diligence of the registration files - Registration strategy planning- Publishing for various types of procedures (IMPD, IMAA, Responses to Questions, Variations)- Participation in preparation of scientific advice in EMA - Direct contact with the Authorities on behalf of multiple clients - Due-diligence of the registration files - Registration strategy planning- Publishing for various types of procedures (IMPD, IMAA, Responses to Questions, Variations)- Participation in preparation of scientific advice in EMA - Direct contact with the Authorities on behalf of multiple clients



Farmaprojects

• Spain
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Specialist

  • Oct 2009 - Feb 2013

  - Publishing for various types of procedures (IMAA, RUP, Responses to Questions, Variations, Renewals, Duplicates)- Registration strategy planning- National submissions as well as DCPs, MRPs in both eCTD and NeeS- Maintenance of the approved Marketing Authorizations (lifecycle management)- Direct contact with the Authorities on behalf of multiple clients- Regulatory support to Sales, Marketing, Manufacturing, Supply and other areas- Interactive liaison within the company, partner companies, external manufacturers and suppliers for all regulatory inquiries



Laboratorios Liconsa

• Regulatory Affairs Specialist

  • Jul 2008 - Jul 2009

  - Publishing for various types of procedures (IMAA, Responses to Questions, Variations)- National submissions as well as DCPs, MRPs in NeeS- Maintenance of the products approved in Europe (variations, renewals, PSUR)- Follow-up of the product information- Price and reimbursement applications of the products in Spain- Cooperation with other departments / units within the structure of company and its external partners (including customers) and Health Authorities - Publishing for various types of procedures (IMAA, Responses to Questions, Variations)- National submissions as well as DCPs, MRPs in NeeS- Maintenance of the products approved in Europe (variations, renewals, PSUR)- Follow-up of the product information- Price and reimbursement applications of the products in Spain- Cooperation with other departments / units within the structure of company and its external partners (including customers) and Health Authorities



Pharmacy “Przy Robercie”

• Pharmacist in charge / Consultant pharmacist

  • Feb 2007 - May 2008

  - Public assistance- Support to pharmacy logistics- Magistral formulations preparation- Pharmaceutical care providence - Public assistance- Support to pharmacy logistics- Magistral formulations preparation- Pharmaceutical care providence



Medical University of Warsaw, Faculty of Pharmacy, Department of Pharmaceutical Chemistry

• Assistant Professor

  • Dec 2006 - Sep 2007

  - Realization of investigation project- Publishing of scientific data- Lectures and laboratories for the students- Personal tutoring for particular students - Realization of investigation project- Publishing of scientific data- Lectures and laboratories for the students- Personal tutoring for particular students



Pharmacy “J. i L. Marcinkowscy”

• Pharmacist in charge / Consultant pharmacist

  • May 2006 - Dec 2006

  - Public assistance- Support to pharmacy logistics- Magistral formulations preparation- Pharmaceutical care providence - Public assistance- Support to pharmacy logistics- Magistral formulations preparation- Pharmaceutical care providence



Science Pharma

• Regulatory Affairs Officer

  • Jun 2005 - May 2006

  - Publishing for various types of procedures with a main focus on CMC (Module 3)- Maintenance of the products approved in Europe (variations, renewals, PSUR)- Responding deficiency letters, supporting of regulatory compliance- Assistance by the harmonization process and direct contact with the Authorities on behalf of multiple clients - Publishing for various types of procedures with a main focus on CMC (Module 3)- Maintenance of the products approved in Europe (variations, renewals, PSUR)- Responding deficiency letters, supporting of regulatory compliance- Assistance by the harmonization process and direct contact with the Authorities on behalf of multiple clients