Advanced Therapy Medicinal Products (ATMP)• Prepare, submit and follow-up Orphan Drug Designation (ODD) and clinical trials• Propose ATMP,s classification• Prepare and submit GMO’s application in accordance with national regulation• Prepare team training on ATMP regulations• Prepare scientific advice procedure • Ex-vivo Gene therapy medicinal productQuality Assurance• Audit pre-clinical study (study plan, process, raw data and repport) according to GLP (OECD and french law)• Audit plan, raw-data and report of tests performed on final product (GMP) and patient analysis (GCP)• Review and closed deviations, OOS, CC and incident.• Review SOPs (technical, general, system)• Maintained QA system in accordance with the regulation• Prepare client audit according to GxP

Chemical drug product (prescription, OTC and hospital)• Managed a drugs portfolio of around 200 MAs/20 active substances• Prepare, submit and follow-up variations (safety and CMC)• Guidance to manufacturing and biological assay on regulatory requirements• Manage the change controls with the different departments (manufacturing, quality…) and submit variations for implementing the changes• Request and manage national requirements after a centralised procedure • Prepare documentation required to support QP release of compliant product• Review of promotional materials and labelling

Intellectual Property/Trade-Mark• Managed the patent portfolio recorded and allowed throughout the world (22 patents filed at the minimum in US, CA, EPO, JP,CN)• Examined “Office Action” and/or “Restriction Requirement” and argued to respond to the examiner• Communicated with patent and trade-mark agents • Ability to interpret WIPO/USPTO/CIPO/EPO patent laws and regulations• Discussed and analysed the patentability of innovations proposed by R&D (by prior art search using database)• Examined the various references in order to inform on barriers, opportunities and research directions that can explore R&D.• Analysed the patents filed by competitor (competitive intelligence)• Analysed the economic market according to our business and our budget to identify the countries where it is important to file the patents.• Managed the trade-mark portfolio• Prepared the declaration of use• Maintained the trade-mark open in each countryScientific • Cancerology• Immunology (antibody/antigen, immunotoxin, hybridoma)• Cellular and molecular biology, neurobiology, cell signaling• Biochemistry methods (Western-Blot, Northern-Blot, PCR, q-PCR, colourimetry)• Validation of analytical methods• Conducting stability studies of finished products and active substances according to ICH guidelines• Software: BLAST, Clustal, PRSS-PRFX Identity sequence, PUBMED

Regulatory Affairs (Canada/FDA/ Europe/France)Medical Device• Submitted medical device application for class 1,2, 3, 4• ISO 9001 and ISO 13485• Prepared Quality Assurance Report (QAR)• Requested and managed electrical certifications (CSA or UL) Natural Health Product/Food supplements• Registered site licence • Collected literature references to write Safety summary report, Evidence Summary report• Submitted application form to obtain NPN• Suggested the best regulatory strategy in response to the authority’s questions • Submission of food supplementary form to DGCCRF (France)• Discussed with national Agencies, DGCCRF and FDA• Reviewed packaging and claims of food supplements (Canada/FDA)• Completed a Quality Assurance ReportCosmetic Product• Reviewed packaging cosmetics according to the Canadian, European, FDA regulations and INCI dictionary• Proposed strategy and claims to market the product according to regulations • Submitted Cosmetic Notifications• Wrote Safety Summary Report• Translated leaflets, packaging or other documents into French and EnglishQuality-Pharmacovigilance• Prepared dossier to release products • Responded to the customer complaints • Transferred and followed the complaints to HPFBI (Canada) or pharmacovigilance department • Wrote and maintained SOP, quality agreements

Chemical drug product (prescription, OTC and hospital)• Submit and maintain Marketing Authorization (MA) for a specified portfolio• Coordinate the Chemistry Manufacturing and Controls (CMC) parts of applications• Update and develop national texts (e.g. SmPC, PIL and packaging artworks)• Implement different strategies in order to meet evolving regulatory (to obtain MA or variation in a minimum of time, to avoid/limit agencies’ questions)

Chemical drug product (prescription, OTC and hospital)• Audit the Chemistry Manufacturing and Controls part of ASMF and finished product• Prepare, submit and follow-up Marketing Authorization Applications (MAA)• Identify and initialized the best strategy for MAA and answer to questions • Prepare the answer to agencies’ question