Regulatory Affairs Assistant Manager

at  Johnson Johnson

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
Organization: Shanghai Johnson & Johnson Pharmaceuticals Ltd

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