Regulatory Affairs Consultant

1 Contribute to delivery of regulatory intelligence and pharmacovigilance (PV) regulatory intelligence for Mainland China and Taiwan.

• Deliver consolidated regulatory intelligence for Mainland China and Taiwan, in accordance with company expectations.

2 Regulatory/PV Regulatory Impact Assessment & Stakeholder Engagement

• Monitoring and analysis of regulatory updates (including laws, guidelines, technical requirements, and trends) issued by the NMPA, CDE, TFDA and other relevant regulatory bodies in Mainland China and Taiwan
• In conjunction with local GRAS SMEs, provide a local assessment/interpretation of new/revised regulatory information and triage for a global impact assessment according to company SOPs
• Manage global impact assessments of new/revised regulatory information for Mainland China and Taiwan according to company SOPs
• In conjunction with local PV SMEs, provide a local assessment/interpretation of new/revised PV regulatory intelligence and triage for a global impact assessment according to company SOP.

3 Regulatory Policy: Intelligence Analysis & Support

• Provide intelligence analyses and support for regulatory policy priorities (e.g., major legislative changes with direct impact on CSL).
  • Track regulatory policy updates trends issued by the NMPA, CDE, and other relevant regulatory bodies in Mainland China and Taiwan.
  • Provide strategic input to company SMEs by curating impact assessments, including evaluating potential impacts on technical and procedural requirements and translating these into actionable insights.
  • Support policy activities by providing preliminary analysis of regulatory challenges and opportunities and insights on how to mitigate risks or capitalise on opportunities
  • Provide analyses according to company processes and using company templates.

Maintain structured regulatory intelligence tracking to ensure timely awareness of emerging regulatory signals.

4 Global-Local Regulatory Alignment & Liaison

• Liaise with local and global GRAS teams/SMEs, clinical, medical affairs, and quality assurance SMEs to ensure alignment on impact assessment activities.
• Advise internal regulatory teams and GRASP Regional Lead on evolving regulatory expectations.
• Ensure alignment between country-specific regulatory intelligence and the company’s global regulatory intelligence/impact assessment framework.

5 Regulatory Intelligence Infrastructure Management

• Develop, maintain, and optimize regulatory intelligence databases, trackers, and internal communication channels.
• Ensure all regulatory intelligence activities adhere to the company’s internal governance policies and compliance standards.
• Support the preparation and conduct of PV inspections and audits, as requested.