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Regulatory Affairs Assistant Manager
Location:
Shanghai
Description:
Description What You Will Do The RA Associate Manager is responsible for: * Lead China RA Regulatory activities & innovative regulatory area. Build strategic regulatory insights into product registration strategies to ensure fast introduction of new products by securing import licenses and domestic licenses. * Proactively partner with internal business stakeholders (local, regional, global), regional franchise teams and Cross-Sector RA partners to develop of innovative regulatory strategies ensuring that regulatory requirements are incorporated upfront and project risks are understood and mitigations in place. * Develop problem-solving strategies which drive efficiency within the project teams, ensure product compliance and deliver high-quality submissions per project timelines for both innovation and Life Cycle management projects (e.g., variations, renewals etc. Key Responsibilities * Support line manager to provide innovative regulatory strategies/direction to the business for relevant Self Care products. * Responsible for submission of local & import NPD/NPI/variation/Renew and keep tracking & feedback to HA efficiently, to ensure project on time deliver. * Develop problem-solving strategies which drive efficiency within the project teams, ensure product compliance and deliver high-quality submissions per project timelines for both NPD and Life Cycle management projects. * Monitor the regulatory environment locally, and globally and provide timely assessments to business leaders of the impact of new/changing regulations on the current and future pipeline. * Provide consultation, and advice to relevant departments to ensure on-time compliance with regulatory guidelines/directives/national requirements. Seek guidance if need * Drive innovative way and generate data to maximize existing product claim opportunity,eg leverage scientific data & consensus to get insert approved. * Lead new TA of Self-Care RA strategy and end to end execution. What We Are Looking For Required Qualifications * University Degree in Pharmacy, Biology, Chemistry or related Life Sciences * Minimum 3 years' experience in drug registrations (with thorough understanding of local NMPA regulations) - ability to critically analyses and apply knowledge to develop innovative regulatory strategies. * Multinational company experience and basic understanding of US and EU regulatory framework desired * Preferred base in Shanghai
Company:
Shanghai Johnson & Johnson Pharmaceuticals
Posted:
April 19 on Equest
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