Substipharm seeks a Project Manager (long term engagement based in Paris)Mission:Project Manager in charge of the realization and overall development follow up of a generic product. This will include pharmaceutical development to bioequivalence studies and drafting of marketing authorisation dossiers in CTD format.
You will be responsible for:
Contacting sub-contractors in the concerned fields,
Verification to ensure that proposed studies are compliant with European requirements in force,
Discussing the quotations,
Follow-up of work progress and redaction of study reports,
Organising follow-up meetings and visits at sub-contractor sites,
Verifying that finished dossiers are fully compliant with European requirements for content and redaction,
Answering internal and external questions regarding your projects,
Ensuring the scheduled dossier submission date to Health Authorities is respected,
Submission of the “ready to submit” dossiers to the Regulatory Affairs Department,
Following-up of technical modifications at the post Marketing Authorisation level.
Profile:Engineer or Doctor in Pharmacy, with a perfect knowledge of European laws applicable in the field of marketing authorisation demands.
Preferably you already have at least five years experience in project management.
Very good command of the English language is required.
Candidates interested in this function and corresponding to the profile are invited to submit their application (CV with a letter of motivation including your availability and salary expectations) to Mr. Laurent TERRASSIN (
lterrassin@substipharm.com).
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