Senior Regulatory Affairs Manager

Novartis UK

Beijing, China
Product registration submission
Regulatory agency negotiation
Product lifecycle management
Directs the development and submission of product registrations, progress reports, supplements, amendments, and/or periodic experience reports

Job Summary

  • Directs the development and submission of product registrations, progress reports, supplements, amendments, and/or periodic experience reports.
  • Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies, ensuring rapid and timely approval of new drugs and continued approved status of marketed drugs.
  • Implements regulatory strategy and manages operational activities for assigned medium regions, providing input into global regulatory strategy and contributing to the Regulatory Functional Plan.

Matching Summary

Directs the development and submission of product registrations, progress reports, supplements, amendments, and/or periodic experience reports.

Skills & Requirements

Must-have

  • Product registration submission
  • Regulatory agency negotiation
  • Product lifecycle management
  • Dossier submission coordination
  • Clinical Trial Applications review
  • Risk Management Plans submission

Nice-to-have

  • Cross-cultural experience
  • Operations management
  • Stakeholder feedback
  • Adherence to policy and guidelines

Key Requirements

  • Functional Breadth
  • Cross Cultural Experience
  • Operations Management and Execution
  • Project Management
  • Clinical Trials
  • Detail Oriented
  • Drug Development
  • Lifesciences
  • Negotiation Skills
  • Regulatory Compliance
  • English language proficiency

Work Rights

Not specified

Tailored Resume

Cover Letter