RA Senior Specialist - 2407022226W

Description

What You Will Do

The RA Senior Specialist – Self-Care 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 Smoking Cessation NPI registration

• China government is highly focusing on healthy China 2030, thus more innovation opportunities will be there for smoking cessation. This role will mainly focus on introduce more NRT products to China through leveraging external favorable policy as well as internal thinktank.

Innovative Submission （Data Generation）

• Drive innovative way and generate data to maximize existing product claim opportunities, leverage scientific data & consensus to get insert approved (save time & budget otherwise require clinical studies), target 3-5 project/ year.

• Support new TA of Self-Care, eg Smoking Cessation drug product registration

RA SME for API & Excipient compliance

• With the new API renewal regulation being issued, 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. The new reg. implication bring us more strategic thinking & reg. interpretation works on API and excipients.

Labeling Innovation for Drug products

• HA will enhance the deployment for Pediatric drug product innovation and registration, there would be more regulatory innovation on pediatric products

Qualifications

What We Are Looking For

Required Qualifications

• University Degree in Pharmacy, Biology, Chemistry or related Life Sciences

• Minimum 2 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

Primary Location Asia Pacific-China-Shanghai-Shanghai

Job Function Regulatory Affairs

Req ID: 2407022226W