CMC / Regulatory Expert (m/w/d) - befristet - FFM

Ort: Frankfurt am Main, Hessen, Deutschland
Gehalt: -
Spezialisierungen: Life Sciences
Vertragsart: Arbeitnehmerüberlassung
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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.

Dieser Geschäftszweig der SThree GmbH betreut die ausgeschriebene Stelle im Auftrag ihres Kunden.

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