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Christine COURTOT-LACROIX
Pharmaceutical PhD (Lyon)
DESS of pharmaceutical industry
—
Since 2007
CMC Expert for the Human and Veterinary Pharmaceutical Industry
—
12 years experience as Regulatory Affairs Manager
(Laboratoire THERAMEX and Laboratoire AGUETTANT)
Responsibilities
	 - Regulatory strategy
	 - Reviewing of dossier (CMC part)
	 - Reviewing R&D protocol to check the compliance with guidelines
	 - Writing, submission and follow-up of marketing authorisation 	
application (national procedure and mutual recognition procedure)
	 - Dealing with authorities and contractors
	 - Participation to working group (LEEM, AFAR)
	 - Project leader for drug development
	 - Project leader for electronic submission
	 - Advertising control and packaging control
	 - Writing, submission and follow-up of price dossier for reimbursement.
	 - Working with the clinical research department on clinical trial declaration
and pharmacovigilance (PSUR)
—
2 years experience as Quality Control Manager (Laboratoire THERAMEX)
Responsibilities	
	 - Control and release of raw materials, packaging
and finished product
	 * Writing of CMC part of licensing-in dossiers
—

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cv-site-uk

  • 1. Christine COURTOT-LACROIX Pharmaceutical PhD (Lyon) DESS of pharmaceutical industry — Since 2007 CMC Expert for the Human and Veterinary Pharmaceutical Industry — 12 years experience as Regulatory Affairs Manager (Laboratoire THERAMEX and Laboratoire AGUETTANT) Responsibilities - Regulatory strategy - Reviewing of dossier (CMC part) - Reviewing R&D protocol to check the compliance with guidelines - Writing, submission and follow-up of marketing authorisation application (national procedure and mutual recognition procedure) - Dealing with authorities and contractors - Participation to working group (LEEM, AFAR) - Project leader for drug development - Project leader for electronic submission - Advertising control and packaging control - Writing, submission and follow-up of price dossier for reimbursement. - Working with the clinical research department on clinical trial declaration and pharmacovigilance (PSUR) — 2 years experience as Quality Control Manager (Laboratoire THERAMEX) Responsibilities - Control and release of raw materials, packaging and finished product * Writing of CMC part of licensing-in dossiers —