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Regulatory Compliance Officer - Temp position long duration

13.07. | Temporaire | 100%

Regulatory Compliance Officer - Temp position long duration

Kelly Scientific is looking for its pharmaceutical partner localized in Switzerland a Regulatory Compliance Officer - Temporary mission (long duration)

Regulatory Compliance Officer - Temporary mission (long duration)

RESPONSABILITIES

* Act as point of contact with plant (R&D, production, technical and analytical/stability departments) and collaborate with worldwide affiliates for regulatory compliance matters
* Approve new product launches, BOM switches, packaging changes and implement in production as well as release systems
* Verify accuracy of documentation and variations packages provided to local affiliates/HAs and follow up on variation status including completion of change controls records to ensure timely implementation
* Participate in change control process from creation, strategy and implementation until closure
* Verify regulatory compliance of locally registered dossiers vs global dossiers and plant practices (ensure regulatory compliance of testing instructions for laboratory)
* Write, review and approve technical documents in English in appropriate format (CTD format). Review and approve stability protocols.
* Identify and evaluate gaps as well as propose regulatory remediation and get escalation process under way in case of non-compliance Provide support during audits and Health Authorities Inspections
* Elaborate SOP and WI for all processes related to team activities and daily tasks
* Evaluate Regulatory Compliance resources for projects and report KPIs
* Prepare and review regulatory annex of Quality Agreements with LOCs

PROFILE

* 3+ years in a Pharmaceutical Quality Environment
* Good experience in Regulatory Affairs/CMC
* Understanding of laboratory techniques
* Good understanding of GMP