Regulatory Compliance Officer - Temp position long duration (BBBH283986) Nyon, Suisse
For our client, GSK Consumer Healthcare company, we are hiring 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