Senior Regulatory Affairs Manager
Core
Lead Regulatory Affairs activities for defined product portfolios in China, enabling business growth while protecting product compliance throughout the lifecycle for medicines, medical devices, cosmetics, and foods.
Role type
Senior Regulatory Affairs Manager (China)
Builds
Compliant product registrations, variations, renewals, and lifecycle maintenance for consumer health brands in China.
Domain
Consumer Health / Regulatory Affairs / China Market
Required skills
Drug Regulatory Affairs expertise, NDA/ANDA/OTC registration, regulatory strategy, dossier preparation, health authority interaction, regulatory risk management, cross-functional leadership, strategic communication, product lifecycle support
Preferred skills
Multi-product classification experience, people/project leadership, matrix organization experience, external regulatory advocacy
Technologies
Regulatory databases, change control systems, internal governance tools
Responsibilities
Lead development of regulatory strategies and dossiers for new product registrations and lifecycle activities; Assess complex regulatory issues and align mitigation plans with stakeholders; Provide regulatory direction for portfolio decisions; Identify emerging regulatory risks and lead cross-functional responses; Build relationships with health authorities and industry associations; Partner with Commercial, R&D, and global teams to ensure compliance; Coach regulatory colleagues and strengthen team capability; Communicate regulatory strategy and decisions to senior stakeholders; Maintain accurate regulatory records and governance systems.