Industry Consultant

MANAGEMENT AND CONSULTING EXPERIENCE

  • More than twenty years of industry experience in vaccines, pharmaceuticals, biotechnology, and combination device products.
  • Expertise in regulatory affairs and regulatory compliance to meet US and European standards.
  • Experience in regulatory strategy for drug development.
  • Experience in writing all modules of the Common Technical Document (CTD) for marketing applications in Europe and US, submission and follow-up.
  • Experience in writing BLA, NDA, ANDA for US submission.
  • Experience in preparation and submission of clinical trials in Europe (new CTA application, IMPD), Canada (CTA) and US (IND process).
  • Experience in preparation of DMFs (Europe, US and Canada) and Site Master File.
  • Liaison with Regulatory Authorities (National European Member State, EMEA and FDA).
  • Preparation of meeting with the EMEA for scientific advice and/or pre-submission and also with the FDA for pre-IND meeting, end of phase II meeting and pre-NDA meeting.
  • Developed many training programs.  Customized in-house Sanofi training for onboard new employee (i.e. “The life of a Medicinal Product”).  Twice a year provides a training in France for IFIS (i.e. US Regulatory Regulation)
  • Completed several quality assessments and audits (FDA - GMP Inspection and GLP Inspection).
  • Developed Quality Systems for Good Research Practice, Good Laboratory Practice and Good Manufacturing Practice.
  • Developed SOPs, batch records, policies and technology transfer documentation.
  • Bilingual with the ability to interact effectively at all organizational levels to provide consulting services, domestically and internationally.

PROJECT EXPERIENCE

 

FDA meeting and IND submission

  • Write and prepare the letter and the list of questions to request a pre-IND meeting with the FDA
  • Write and prepare pre-IND Package 
  • Attend ≈20 FDA meeting (i.e pre-IND meeting and Type C meeting) as a coordinator or scribe depending on the need from the Sponsor
  • Write and prepare the IND in a eCTD format (modules 1, 2, 3, 4 and 5)
  • Submit IND electronically
  • Maintenance of IND as amendment and annual report

 

Product and therapeutic area

  • Two (2) HIV viral vector vaccine and one investigational vaccine with the Division of Vaccines and Related Products Applications (CBER)
  • One (1) rotavirus vaccine exUS development (Australia and South Africa))
  • One (1) antibacterial vaccine (CBER)
  • Eight (8) stem cell products with the Office of Cellular, Tissue and Gene Therapies (CBER)
  • Three (3) investigational products with the Division of Cardiovascular and Renal Products
  • Three (3) investigational products with the Division of Dermatology and Dental Products including one dermatological/cancer investigational product
  • One (1) investigational products with the Division of Gastroenterology and Inborn Errors Products
  • Two (2) investigational products (one biosimilar and one small molecule) with the Division of Pulmonary, Allergy and Rheumatology Products
  • One (1) investigational product with the Division of Bone, Reproductive and Urologic Products
  • Two (2) investigational products with the Division of Hematology Products
  • Three (3) combination product for neuro/oncology products
  • Three (3) investigational product with the Division of Neurology Products

 

Pre-NDA meeting and information package submission

  • Write and prepare the letter and the list of questions to request a pre-NDA meeting:
    • FDA Division of Anesthesia, Analgesia, and Addiction Products
    • FDA Division of Division of Gastroenterology and Inborn Errors Products
    • FDA Division of Pulmonary, Allergy and Rheumatology Products
    • FDA Division of Vaccines and Related Products Applications (CBER)
  • Write and prepare pre-NDA Package 

 

Orphan designation Application 

  • Write and prepare the orphan designation application
  • Write and prepare orphan grant application

 

Product and therapeutic area

  • One stem cell product
  • Two (2) cardiovascular investigational product
  • One dermatological investigational product
  • One small molecule GI tract
  • One for DMD indication
  • One for ALS indication
  • One for combination product for oncology product
  • Two (2) for pancreatic cancer
  • One for narcolepsy

 

Clinical Investigator’s brochure

  • Write and prepare/update IB from nonclinical and clinical study reports

 

Product and therapeutic area

  • One HIV viral vector vaccine 
  • One Rotavirus Vaccine
  • One stem cell product
  • Two dermatological investigational products
  • One dermatological/cancer investigational product

 

Clinical protocol

  • Write and prepare a draft clinical protocol to be edited by the principal investigator

 

Product and therapeutic area

  • One dermatological investigational product
  • One Rotavirus product

 

BLA, NDA and ANDA submission

  • Write and Prepare two NDA 505(b)(2) pathway for opioid product and injectable product
  • Write and prepare NDA 505(b)(2) pathway (Module 3 and Module 2 QOS) for a combination product (pump and product)
  • Write and prepare a BLA modules 2 and 3 for a blood product
  • Write and prepare a BLA modules 2 and 3 for a stem cell product
  • Write and prepare Module 3 for a BLA application from batch records and SOPs and Module 2 for two conjugate vaccines, submission through mutual recognition and centralised procedure in Europe and US and follow-up
  • Write and preparation Modules 2, 3 and 4 of a CTD for an Hepatitis B vaccine
  • Write and prepare Module 3 and Module 2 for a 505(b)(2) NDA for a opioid product
  • Write and prepare 505(b)(2) NDA modules 1, 2, 3, 4 and 5 for a combination device-drug (reformulation of an existing product) – and submit electronically
  • Prepare four (4) 505(b)(j) ANDA modules 1, 2, 3 and 5 and submit electronically 
  • Preparation of 8 DMFs for conjugate vaccine products and silver API

 

BLA, NDA and ANDA Post Approval submission/CRL Responses

  • Assist in the preparation of 3 Complete Response Letters (CRL) 
  • Use several amendments to update a BLA NDA modules 2 and 3 for several vaccine products (Flu-type)
  • Convert and update Module 2 and Module 3 for 4 antibiotic products
  • Convert a PreApproval Supplement into a Type 2 Variation for European submission for a vaccine product

 

DMF submission

  • Review and submit electronically 5 DMF for a European API facility
  • Review and submit electronically 3 DMF for an Argentinian API facility 
  • Assist in FDA inspection 
  • Prepare and submit electronically Drug Establishment Registration and Self Identification
  • Maintenance of all DMFs

 

Electronic Submission

  • All IND and NDA/BLA were prepared for electronic submission
  • Lorentz Software for publishing 
  • Submission via the FDA Gateway Portal

 

Regulatory Compliance

  • Evaluation of the process validation for a monoclonal antibody with emphasis on leachables and extractables.
  • Preparation of SOPs, Batch Records and technology transfer to GMP manufacturer for a viral vaccine delivery system.  
  • Audits of research laboratories (GLP oriented) for IND purposes and preparation of manufacturing plant (GMP oriented) for FDA pre-approval inspection.  
  • Review all CAPA for all vaccine products for a Big Pharma



PROFESSIONAL EXPERIENCE

 

2000-present Industry Consultant

Denver, CO, USA

 

1998-2000 Regulatory Affairs Associate

 

1996-1998 Senior Regulatory Affairs Executive

VALORUM Inc, Research Triangle Park, NC,  USA

 Regulatory Affairs Manager

PHARMAKOPIUS INTERNATIONAL Ltd - READING, UK

 

1995-1996 Regulatory Affairs Consultant

EUROPEAN REGULATORY AFFAIRS - READING, UK

 

1994-1995 Project Manager Assistant

APPLIED MICROBIOLOGY, Inc - NEW YORK, USA

 

1992-1994 Post-Doctoral Scientist

REGENERON, Inc - NEW YORK, USA

 

1987-1992 PhD Program (Mr le Professeur J Cros)

LABORATOIRE DE PHARMACOLOGIE ET TOXICOLOGIE FONDAMENTALES - TOULOUSE, FRANCE 

 

1986-1988 Master of Science

SANOFI RECHERCHE - LIGNES PEPTIDES - TOULOUSE, FRANCE



EDUCATION

 

  • PhD Program - Option Cell Biology and Biochemistry

Supervisor: Dr M Webber

Purification and characterisation of two cholinergic differentiation factors.  Laboratoire de Pharmacologie et Toxicologie Fondamentales - Toulouse, France

 

  • Master of NeuroSciences and Behavioural Studies

Study of neurodegenerative diseases of both central and peripheral nervous systems.  Université Paul Sabatier - Toulouse, France

 

LANGUAGES

 

English - fluent

French - fluen

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