Experience

Towa Pharma Spain

• Spain
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Specialist

  • Feb 2020 - Present



ISDIN

• Spain
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs

  • Aug 2018 - Feb 2019

  Cosmetics: • Responsible of PIF preparation and maintenance for skin and body care products. • CPNP notification (European Cosmetics Portal) • RA coordination of new product development: close contact with formulation, packaging, safety and clinical departments. Cosmetics: • Responsible of PIF preparation and maintenance for skin and body care products. • CPNP notification (European Cosmetics Portal) • RA coordination of new product development: close contact with formulation, packaging, safety and clinical departments.



Fresenius Kabi

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Regulatory Affairs Pharmacist / NSO Deputy

  • Jun 2010 - Jul 2018

  Drug medicines: • RA production plant responsible. • Registration Procedures (New Drug Application): CP, MRP, DCP and National • Follow up and maintenance of MA: variations, renewals and responses to deficiency letters. • Drug Substance Module 3.2.S section management: ASMF open parts, CEPs. • Publishing in eCTD Manager (Extedo). • Reimbursement and pricing applications of medicinal products in Spain. • Daily use of CESP – RAEFAR - LABOFAR – EDQM • Intradepartmental support: Marketing, Supply Chain, Quality Assurance, and Production. • Liaising closely with the Health Authorities. • Participation in multidisciplinary teams providing regulatory guidance and strategy. Daily contact with European counterparts. Medical Devices: • Responsible of Technical Documentation • Post-Marketing Surveillance activities. • Audits with the Notified Body (TÜV). • Extension and renewal of CE certification. • Reviewing of artworks to ensure regulatory compliance. Food for Special Medical Purposes (FMP): • Registration and reimbursement procedures of Food for Special Medical Purposes in touch with the corresponding competent Authorities. Vigilance: • Management of ADR locally, PSURs, literature searches and periodic EudraVigilance searches, safety variations, Field Safety Notes. Show less



ASPHALION

• Spain
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Regulatory Affairs Officer

  • 2009 - 2010

  • Registration procedures (MRP, DCP and national) and licence maintenance (variations, renewals, letters of deficiencies). • Publishing in eCTD Manager (Extedo) • Daily use of Heath Agency Portals website. • Readability test management. • Reviewing and checking of artworks. • Preparation of SmPC and PIL • Direct contact with the Authorities on behalf of multiple clients. • Update of Modules 2, 3 and 5. • Registration procedures (MRP, DCP and national) and licence maintenance (variations, renewals, letters of deficiencies). • Publishing in eCTD Manager (Extedo) • Daily use of Heath Agency Portals website. • Readability test management. • Reviewing and checking of artworks. • Preparation of SmPC and PIL • Direct contact with the Authorities on behalf of multiple clients. • Update of Modules 2, 3 and 5.



Grifols

• Spain
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Officer

  • 2007 - 2009

  Regulatory Affairs Technician • Preparation and check of artworks for different countries. • Responses to deficiency letters and licence renewal procedures. • Compilation of quality and clinical documentation for registration purposes. Regulatory Affairs Technician • Preparation and check of artworks for different countries. • Responses to deficiency letters and licence renewal procedures. • Compilation of quality and clinical documentation for registration purposes.



Ranbaxy

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Technician (Practice)

  • Apr 2007 - Jun 2007

  Practice contract with CESIF Practice contract with CESIF



Alcon

• Switzerland
• Medical Equipment Manufacturing
• 700 & Above Employee

• Quality Control. Microbiology (Practice)

  • Jan 2007 - Apr 2007

  Practice contract with CESIF Practice contract with CESIF