Consulting Regulation CMC – Confirme – H F Mission

Description de la mission

Consulting Regulation CMC – Confirme – H/F (Mission)
Saclay, IDF, France (Hybride)
Mission (8 mois 17 jours)
Publié il y a 2 jours
Pharmacy
Manufacturing
Anglais
Chemistry
Context for this Freelance/Self-employed mission: For one of our client, we are looking for a consultant in CMC Regulation (Small Molecules in development) for the Regulatory CMC Department (CMC Chemistry, Manufacturing and Controls)

Missions:
Support the team in place for RtQ activities in Europe, USA and other countries in the submission of the NDA/MAA for a small molecule oncology product in development
Participate in writing answers to questions
Participate of the management RtQ process (timelines, trackers)

Skills:
5 years experience in CMC technical roles (Chemistry, Manufacturing and Controls)
Proven track record of effective stakeholder management
Ability to manage multiple activities concomitantly
Degree in Pharmacy or a relevant science/technical subject
Fluent in English

Location: Mission onsite in Saclay with partial remote to be discussed
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