CMC Regulatory Assistant – Junior – H F – Full Remote Mission

Description de la mission

CMC Regulatory Assistant – Junior – H/F – Full Remote (Mission)
Saclay, IDF, France (Hybride)
Mission (8 mois 11 jours)
Publié il y a un jour
Pharmacy
Manufacturing
Anglais
CMC
Context for this Freelance/Self-employed mission: For one of our client, we are looking for an Assistant CMC Regulatory Consultant for the Regulatory CMC Department (Chemistry, Manufacturing and Controls).

Missions:
Lead the CMC Regulatory strategy for all post-approval activities of the asset, providing proactive and timely advice to the technical team
Manage and deliver all regulatory aspects related to Change Control requests
Lead and deliver all project management activities to support the CMC post-approval work of the asset to ensure the necessary regulatory documents are delivered in time and with the adequate quality
Liaise with the Local Affiliates as needed to develop efficient regulatory strategies to deliver the CMC Dossier in line with country requirements and agreed timelines
Represent CMC Regulatory across the relevant governance meetings and activities
Write, review and compile (as needed) all regulatory documents in support of each submission on time and in line with country requirements
Generate gap analysis and risk management support for each submission as needed
Identify rate limiting deliverables and interdependencies across the technical and regulatory aspects of the different submissions
Provide status updates to all stakeholders as needed
Management of all documents through the document management system

Skills:
Assistant CMC Regulatory ((Chemistry, Manufacturing and Controls)
English

Location: 3 days/week onsite in Saclay and 2 days/week Remote — Full Remote possible
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