Experience

CataloniaBio & HealthTech

• Spain
• Biotechnology Research
• 1 - 100 Employee

• Member of the Board

  • Mar 2018 - Present



ASPHALION

• Spain
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• General Manager, Regulatory Affairs

  • Oct 2016 - Present

  Strategic Regulatory Affairs and Drug Development Consultant for Europe, FDA and worldwide.Leading a steadily growing Company since 2003, with a team of over 90 professionals.

• Regulatory Affairs Consultant

  • Jan 2003 - Present

  - Strategic Planning and Execution of Registration Procedures in Europe and North America, and LATAM.- Centralised Procedures for New Chemical Entities and Advanced Therapy Medicinal Products. European Registration procedures, MRP, DCP National.- Scientific Advice given by European Agencies and FDA meetings. - Paediatric Investigational Plan, Waiver and Deferrals.- Due diligences of medicinal product dossiers or complete portfolio.- Deputy QPPV for Asphalion S.L. Pharmacovigilance System.- Qualified local drug safety contact/Spain as required by the local regulation- Implementation of Pharmacovigilance Regulation 2012, including Art 57 submission, Pharmacovigilance System Master Files, PSURs, Risk Management Plans, PhV Audit preparation, MedDRA coding.Training experience:From 2004 : in-house and open seminars regarding: European Registration Procedures, FDA Regulatory Framework, Medical Devices, Stability of Medicinal Products, Analytical Methods and Validations, Drug Master Files and Active Substance Master Files, Development of Vaccines, Regulation on Clinical Trials in Europe, Pharmacovigilance.From 2005: Presenting seminars and workshops for IL3 - Institute for LifeLong Learning ­Universitat de Barcelona: Stability of Medicinal Products, Clinical Trials in Europe, Practical aspects of Quality by Design and PAT applied to Regulatory Submissions, Variations.From 2007 : Presenting in-house and open seminars organised by IIR on: European Registration Procedures, FDA Regulatory Framework. Show less



Laboratorios Menarini, S.A.

• Qualified Person

  • Dec 1992 - Dec 2002

• Regulatory Affairs Director

  • Sep 1988 - Dec 2002



LABORATORIOS MENARINI

• Vice-Director Research and Development ­ Regulatory Affairs

  • Jan 1998 - Jan 2002



TECEFARMA, S.A

• Qualified Person (Technical Director)

  • Jan 1990 - Jan 2002



LABORATORIOS MENARINI

• Regulatory Affairs Director

  • Jan 1988 - Jan 1997

  - Coordination of the procedures for European registration (Mutual Recognition Procedure) of the Company investigational products, being Spain the Reference Member State, in close collaboration with European Regulatory Agencies. - Coordination and management of the development and the preparation of Registration Dossiers, within the Research and Development Department. - Collaboration in Pharmacovigilance functions, together with the Responsible of Pharmacovigilance. - Responsible for Customer Service on technical in all the consultations about the Company medicinal products. - Direct contact with the Sanitary Authorities for the follow-up of the Registration Dossiers and variations submitted at the Health Authorities. - Participation in other procedures of European registration, not being Spain the Reference Member State. - Training of the Research and Development team about the international guidelines of development of new pharmaceutical products and European regulations. Organisation of Exhibitions and Conferences. - Organisation of the preparation of registration dossiers for licenses, collaborating with licensor companies. Show less