CMC / Regulatory Expert (m/w/d) - befristet
Aktuell unterstützen wir einen unserer Kunden bei der Suche nach temporärer Unterstützung im Bereich CMC / Regulatory Compliance.
Aufgaben:
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 authorisations worldwide (territory extensions, renewals, site registrations and transfers, new submissions) by writing and approving
- 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
Voraussetzungen:
- Ph.D or Master in a science/health field (e.g. Mathematic, Chemistry, Pharmacy, Biology, Biotechnology Sciences etc.) or equivalent
- Knowledge of global regulations/guidelines, key Health Authority/Industry thinking and trends is perferrable
- 2-5 years of direct Regulatory CMC experience is preferred
- Technical pharmaceutical CMC experience (laboratory, manufacturing, etc.) is desirable
- Experience of manufacturing operations, Biotechnologies, Biological products is a plus
- Capability of resolving strategic technical and regulatory issues
- Should demonstrate initiative, independent thinking, anticipatory foresight
- Strong communication skills
- Business level in German and English (written & spoken)
Details:
Start: ASAP
Volumen: Vollzeit / 37,5 h / Woche
Ende: 30.11.2021
Diese Position ist aktuell im Rahmen einer Expertenüberlassung (Arbeitnehmerüberlassung) zu besetzen.
Bei Interesse freue ich mich auf Ihre Rückmeldung.
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