Regulatory Affairs, Assistant Manager/ Senior Executive

Gsicareers

Hong Kong, , HK
Regulatory dossier preparation and submission
Lifecycle maintenance document management
Coordination with clinical and commercial teams
You will support and deliver regulatory activities that help ensure product availability and compliance in Hong Kong and Macau

Job Summary

  • You will support and deliver regulatory activities that help ensure product availability and compliance in Hong Kong and Macau.
  • This role offers visible impact for patients, clear ownership, and strong opportunities to grow your regulatory career while uniting science, technology and talent to get ahead of disease together.
  • GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that efforts focus on accelerating significant assets that meet patients’ needs.

Matching Summary

You will support and deliver regulatory activities that help ensure product availability and compliance in Hong Kong and Macau.

Skills & Requirements

Must-have

  • Regulatory dossier preparation and submission
  • Lifecycle maintenance document management
  • Coordination with clinical and commercial teams
  • Submission tracking and audit readiness
  • Responding to regulatory authority queries
  • License maintenance and renewals
  • Artwork compliance management

Nice-to-have

  • Experience influencing stakeholders
  • Coaching junior colleagues
  • Working in a matrix environment
  • Background in biologics or oncology
  • Growth mindset and collaborative attitude
  • Strong organisational skills
  • Multilingual communication skills

Key Requirements

  • Bachelor’s degree in pharmacy, life sciences, chemistry or related discipline
  • 3-5 years regulatory affairs experience in pharmaceutical or healthcare industry
  • Knowledge of Hong Kong and Macau regulatory requirements
  • Strong written and verbal communication skills in English
  • On-site work in Hong Kong

Work Rights

Not specified

Tailored Resume

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