RA Manager

1. Strategic Leadership & Planning:
 Develop and implement comprehensive regulatory strategies for product registration
and life-cycle management in China.
 Lead the preparation, compilation, and submission of high-quality registration
dossiers (e.g., IND, NDA, MAA) to the NMPA.
 Monitor and analyze evolving regulatory requirements, guidelines, and policies in
China, assessing their impact on company operations and providing strategic advice
to senior management.
2. Client & Product Support:
 Serve as the primary regulatory contact for clients, providing expert guidance on
their product registration pathways and requirements.
 Support and maintain client product registration applications, ensuring accuracy,
completeness, and adherence to timelines.
 Manage the entire registration process from pre-submission meetings to approval,
maintaining constant communication with health authorities.
3. Cross-Functional Collaboration:
 Support Business Development (BD) Teams: Provide critical regulatory intelligence
and feasibility assessments for new business opportunities, potential partnerships,
and in-licensing products.
 Support Project Initiation/Product Development Teams: Offer early-stage regulatory
guidance to ensure new projects are designed with China-specific regulatory
requirements in mind. Review and advise on CMC, non-clinical, and clinical
development plans.
 Collaborate closely with internal departments including Clinical Development,
Quality Assurance, Pharmacovigilance, and Marketing.
4. Team & Compliance Management:
 Lead, mentor, and develop the local registration team (if applicable).
 Ensure all regulatory activities are conducted in strict compliance with local laws,
company SOPs, and global regulatory standards.
 Manage the regulatory archive system, ensuring all documentation is inspection-
ready.