Description
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.)

• Lead for implementation stage of all franchise based strategic projects, including coordination for dossier preparation, dossier compiling, submission, tracking, etc.
• Manage regulatory activities across a designated product range within the OTC portfolio, seeking guidance as required.
• Proactively partner with internal business and supply chain 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.
• Establish and maintain good working relationships with regulatory authorities (Provincial FDA, NMPA, CDE, CFDI, institute for drug control etc.) to ensure effective product registrations, and represent the company in regulatory industry associations to positively influence the regulatory environment.
• 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

• University Degree in Pharmacy, Biology, Chemistry or related Life Sciences.
• Minimum 10 years’ experience in OTC industry (with thorough understanding of local NMPA regulations & technical guidelines) - ability to critically analyze and apply knowledge to develop innovative regulatory strategies, ability to implement projects strategies with products, process, controls knowledge etc. Pharmacy technical (formulation, process, registration regulation, etc.) experiences is preferred.
• Multinational company experience and basic understanding of US and EU regulatory framework desired.
• Developing an external engagement network across NMPA, Provincial FDA’s and Industry Associations is desired.
• Ability to operate across a wide range of business activities, including in-licencing projects.
• Ability to work in a matrix organization, managing multiple complex projects, priorities and systems simultaneously. Able to re-prioritize in an ever-changing environment.
• Demonstrated leadership and problem-solving skills, ability to work independently and seek guidance as needed.

Primary Location Asia Pacific-China-Shanghai-Shanghai

Job Function Regulatory Affairs