Descrição da Vaga
Support and facilitate on-site regulatory CMC related launch and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the site specific (global and local) products to ensure timely supply to the markets in compliance with current regulatory obligations and requirements and champion experience sharing within the site. • Regulatory transmission: Act as single point of contact and advisor for worldwide regulatory intelligence information on the site. Maintain a close collaboration with RA CMC and RA in order to keep track of new regulatory requirements, strategies and the knowledge of the global product dossiers (CTD module 3). Participate in the CMC facilitator network sharing lessons learned, providing expertise to facilitators from other sites and raising issues for resolution. Coach, train and develop the site’s personnel on regulatory specific aspects of change management by sharing lessons learned and regulatory intelligence information with the goal of improving their skills and capabilities for handling change requests and maintaining regulatory compliance and support sites in setting standards for regulatory relevant information included in CMC modules.Requisitos mínimos
Minimum: Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent. Desirable: Advanced degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnolog Fluent English (oral & written). Good skills in site (local) language (oral & written). 4-6 years or more experience in pharmaceutical manufacturing site and/or QA/QC or in technical development; solid know-how in pharmaceutical technology; project management experience; 2 years or more experience in Regulatory Affairs CMC preferable.