DescriptionWhat You Will DoThe 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.**Qualifications**:**What We Are Looking For**Required Qualifications- University Degree in Pharmacy, Biology, Chemistry or related Life Sciences- Multinational company experience and basic understanding of US and EU regulatory framework desired- Preferred base in ShanghaiPrimary Location Asia Pacific-China-Shanghai-ShanghaiJob Function Regulatory AffairsOrganization: Shanghai Johnson & Johnson Pharmaceuticals Ltd.
