Regulatory Expert-CMC

Ort: Deutschland
Gehalt: verhandlungsfähig
Spezialisierungen: Regulatorische Anforderungen
Vertragsart: Freie Mitarbeit / Projektmitarbeit
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Jobbeschreibung:

Einsatzzweck:
Regulatory Compliance:
- Supports batch release by following submission and approval to ensure the product regulatory compliance
- Ensures that the CMC dossier is in line with manufacturing and control procedures and with dossiers approved by Health Authorities
- Contributes to site inspections and audits
- Supports product licenses maintenance and site registration
- Reviews and signs-off documents like SOPs or technical reports

Change Control:
- Assesses and manages change control activities with regulatory impact for the site
- Provides regulatory expertise to site projects
- Manages regulatory activities linked to change controls including updating of the CMC files

CMC Documentation Management:
- Supports Marketing authorizations worldwide (territory extensions, renewals, site registrations and transfers, new submissions) by writing and approve
- Optimizes the content of CMC dossiers to facilitate the management of future changes
- Writes ready for submission CMC regulatory documents/dossiers to be dispatched to regulatory affairs functions and supports CMC writing performed
- Prepares with contribution of site experts answers to questions from Health Authorities

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