Regulatory Affairs Senior Specialist 法规事务高级专员 - 2407020761W

Description

What you will do

The Regulatory Affairs Senior Specialist 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 AEP DMF Regulation and implementation.

1) API re-registration regulation and variation regulatory support, 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.

2) The new reg. implication brings us more strategic thinking & reg. interpretation works on API and excipients. There will be 100 bexcipents regulations and packaging material regulation be draftted in the coming year.

• Jupiter DP registration Submission.

1) Drive innovative way and generate data to maximize existing product claim opportunity, by leveraging scientific data & consensus to get insert approved (save time & budget otherwise require clinical studies).

2) Support drug product registration produced in XJP plant. Familiar with AEP DMF requirement, support on API variation and re-registration activities.

3) 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 and CCDS implementation for drug products

1) HA will enhance the deployment for Elderly-Oriented Simplification of the Drugs instruction(PI), Kenvue 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.

2) Responsible for CCDS implementation in CN, responsible any HA comminciation if needed.

• Support on external regulation shaping. To 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, interpretation and advice to relevant departments to ensure on-time compliance with regulatory guidelines/directives/national requirements.

Qualifications

What we are looking for

Required Qualifications

• Minimum 3-5 years’ experience in drug, especially OTC 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.

• Master’s degree in pharmacy, Biology, Chemistry or related Life Sciences.

Primary Location Asia Pacific-China-Beijing-Beijing

Job Function Regulatory Affairs

Req ID: 2407020761W