Regulatory Affairs Manager
Trovato in: Talent IT C2 - 3 settimane fa
Your Job
Prepare, submit and gain approval for regulatory applications to AIFA (MAA, renewal, variations). Assess and respond to regulatory questions to resolve issues. Management of post-approval activities as required. Review and submission (where applicable) of promotional and non-promotional materials. Strategic and operational customer support with company set-up activities and with national requirements to market medicinal products in Italy. Translations and review of Product Information (Linguistic Review). Management of activities related to educational materials. Communication with Clients and Health Authorities. Project Management, execution of activities, progress monitoring until end of project. Advisor to Clients on regulatory procedures and requirements in consultation with senior management. Advisor to Clients on strategic issues based on experience and knowledge in consultation with senior management. Flexibility to respond to client demands (also outside strict regulatory framework) according to required timelines. Travel to client meetings as required or participation in TCs. Develop and maintain a thorough knowledge of European and national regulatory requirements. Maintain the Company’s values and work ethos. Participation in archiving activities.
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