직업 종류: Full-time
작업 내용
Mandated by our client company, we are looking for a Regulatory Manager, who will be responsible for managing and coordinating regulatory and strategic activities to company submissions (Pharma and IVDD, IVDR). This position will report to Head of Quality & Regulatory.
Responsibilities:
• Provide regulatory and strategic management to company submissions (Pharma and IVDD, IVDR)
• Liaison with Regulatory Authorities (EU, US, China, Japan)
• Effectively address regulatory issues that may surface during regulatory reviews and prepare and facilitate preparation of responses to Authorities in various countries worldwide
• Responsible for development and implementation of the Regulatory Strategy and Risk Documents
• Provide regulatory and strategic input on: development concepts and documents (e.g. dev plan, CTA/IND, briefing books, dossier documents); clinical study protocols and protocol amendments
• Convey critical knowledge, especially relating to assigned products to alleviate or reduce regulatory impacts and costs.
• Comply with applicable SOPs, GOPs and WIs
Requirements:
• BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred. Alternatively several years of regulatory or other relevant industry experience
• Fluent English required (oral and written)
• At least 3 years of relevant regulatory experience in Pharma and /or IVD
• Good understanding of regulatory requirements for drug development and IVD, clinical studies, dossier filings worldwide
• Experience in HA negotiations in different regions (EU, US, China, Japan)
• Strong interpersonal skills, team player
마감 시간: 13-05-2024
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