Director - Regulatory Science

• Jan 2022 - Present

Associate Director - Regulatory Science

• Jan 2021 - Feb 2022

Senior Regulatory Scientist

• Apr 2016 - Jan 2021

Regulatory Affairs Manager - International Registration

• Mar 2013 - Jan 2016

- Define and implement strategies for regulatory submissions for obtaining MA and maintaining (variations, renewals) approvals for Orphan products in International markets including Asia, Middle East Africa and Canada - Ensure that the pharmaceutical products distributed in those countries meet the local regulatory requirements and support the local sales and marketing organization - Ensure that pharmacovigilance obligations are met in the territories covered by the business -… Show more - Define and implement strategies for regulatory submissions for obtaining MA and maintaining (variations, renewals) approvals for Orphan products in International markets including Asia, Middle East Africa and Canada - Ensure that the pharmaceutical products distributed in those countries meet the local regulatory requirements and support the local sales and marketing organization - Ensure that pharmacovigilance obligations are met in the territories covered by the business - Responsible for coordinating all aspects of regulatory submissions for clinical trials (CTA), Orphan Drug Designation procedures in International markets

Regulatory Affairs Manager

• Dec 2009 - Feb 2013

Clinical Development: - Conduct of Regulatory Assessment during Due Diligence and acquisition process - Provide regulatory support and strategic advice to senior management, project teams, key internal/external customers - Elaboration of the Regulatory Strategy for Registration in collaboration with CMC, Pre-clinical and Clinical teams - Regulatory expertise on Name Patient Programs - Review of clinical documentation (protocols, amendment) - Writing of IMPDs -… Show more Clinical Development: - Conduct of Regulatory Assessment during Due Diligence and acquisition process - Provide regulatory support and strategic advice to senior management, project teams, key internal/external customers - Elaboration of the Regulatory Strategy for Registration in collaboration with CMC, Pre-clinical and Clinical teams - Regulatory expertise on Name Patient Programs - Review of clinical documentation (protocols, amendment) - Writing of IMPDs - Coordination and submission of clinical trial applications in EMEA countries - Coordination and submission of answer to questions from Competent authorities (including writing of the documentation) - Communications/Negotiations with National Agencies - Communications/Negotiations with External Vendors - Set up the appropriate archiving process for Regulatory documentation related to Clinical Trials - Pharmacovigilance (Regulatory expertise, ASR, DSUR) - Participation in the Annual update of the Investigators Brochure - Development, implementation and training of relevant Clinical Trial SOPs. Paediatric Regulation : - Provide regulatory expertise and strategic advice to senior management, project teams - Writing, preparation and submission of Paediatric Investigation Plan, Compliance Check and Paediatric Annual Reports - Communications/Negotiations with EMA Pediatric Group

Regulatory Affairs Manager

• 2006 - 2009

Clinical Development: -Review of clinical documentation (protocols, amendments, IMPDs) -Coordination and submission of clinical trial applications, amendments for international multicentres studies (phase I to III) (cardiovascular area) -Answers to questions from Competent Authorities -Pharmacovigilance (expedited and periodic reportings) Paediatric Regulation: -Regulatory intelligence on Paediatric regulation (EU and US) - Performed presentations on Pediatric… Show more Clinical Development: -Review of clinical documentation (protocols, amendments, IMPDs) -Coordination and submission of clinical trial applications, amendments for international multicentres studies (phase I to III) (cardiovascular area) -Answers to questions from Competent Authorities -Pharmacovigilance (expedited and periodic reportings) Paediatric Regulation: -Regulatory intelligence on Paediatric regulation (EU and US) - Performed presentations on Pediatric Regulation in various internal meetings - Writing, review and submission of Paediatric Investigation Plans Show less Clinical Development: -Review of clinical documentation (protocols, amendments, IMPDs) -Coordination and submission of clinical trial applications, amendments for international multicentres studies (phase I to III) (cardiovascular area) -Answers to questions from Competent Authorities -Pharmacovigilance (expedited and periodic reportings) Paediatric Regulation: -Regulatory intelligence on Paediatric regulation (EU and US) - Performed presentations on Pediatric… Show more Clinical Development: -Review of clinical documentation (protocols, amendments, IMPDs) -Coordination and submission of clinical trial applications, amendments for international multicentres studies (phase I to III) (cardiovascular area) -Answers to questions from Competent Authorities -Pharmacovigilance (expedited and periodic reportings) Paediatric Regulation: -Regulatory intelligence on Paediatric regulation (EU and US) - Performed presentations on Pediatric Regulation in various internal meetings - Writing, review and submission of Paediatric Investigation Plans Show less