Regulatory Affairs Assistant Manager
hace 24 horas
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
- 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
Organization: Shanghai Johnson & Johnson Pharmaceuticals Ltd.
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