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RA Associate Manager
Location:
Shanghai
Description:
Description What You Will Do The RA Associate Manager - Self-Care 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 RA SME for Drug packaging Regulation • China HA will be more standardized and stricter requirement for drug packaging materials which has been highlighted in ChP 2025 Outline. 65 packaging regulations are draft in 2023, around 300% increase Vs 2020 ChP Innovative Submission ( Data Generation ) • Drive innovative way and generate data to maximize existing product claim opportunities, leverage scientific data & consensus to get insert approved (save time & budget otherwise require clinical studies), target 3-5 project/ year. • Support new TA of Self-Care, eg Smoking Cessation drug product registration RA SME for API & Excipient compliance • With the new API renewal regulation being issued, China HA has the same administration of Drug and APIs, which means the life circle management of APIs is stricter than before, including period renewal requirement, post market variation approval, etc. The new reg. implication bring us more strategic thinking & reg. interpretation works on API and excipients. Jupiter portfolio remediation • The Jupiter products post market management becomes more complex with the development of Project WU and ongoing projects, e.g., API legacy CDE homework, address correction remediation, legacy issue of PET OOS for DAK Cream, etc. which will bring more complex communication and strategic thinking to deal with the ambiguities. Labeling Innovation for Drug products • HA will enhance the deployment for Elderly-Oriented Simplification of the Drugs instruction(PI), SJJP is required by local FDA as one of the key participants of this innovation, there would be more labeling regulation discussion with HA and lead the industrial opinions, and support on the internal implementation. • In addition, regulation regarding to special population usage and storage description optimization of labelling has been released. 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
Company:
Shanghai Johnson & Johnson Pharmaceuticals
Posted:
June 21 on Equest
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