Job Information
J&J Family of Companies Regulatory Affairs Assistant Manager in Shanghai, China
Regulatory Affairs Assistant Manager - 2407018448W
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.
Qualifications
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
Primary Location Asia Pacific-China-Shanghai-Shanghai
Job Function Regulatory Affairs
Req ID: 2407018448W
J&J Family of Companies
-
- J&J Family of Companies Jobs
