Regulatory Affairs Assistant Manager
Posted:
Friday, 19 April 2024
Valid Thru:
Sunday, 19 May 2024
Index Requested on:
04/19/2024 14:01:14
Indexed on:
04/19/2024 14:01:14
Location:
Shanghai, 31, , CN
Industry:
Advertising and Public Relations
Occupational Category:
13-0000.00 - Business and Financial Operations
Type of Employment: FULL_TIME
Shanghai Johnson & Johnson Pharmaceuticals Ltd. is hiring!
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.
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
Responsibilities:
Please review the job description.
Educational requirements:
Desired Skills:
Please see the job description for required or recommended skills.
Benefits:
Please see the job description for benefits.
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