Regulatory Affairs Director - Pharmaceuticals

Basic qualifications:

Essential Skills and Abilities:

  • Bachelor of Pharmacy and a registered pharmacist in Hong Kong
  • Exceptional leadership skills
  • Experience in team and people management
  • Excellent oral and written communication skills
  • Proven influence and impact skills across business levels and functions
  • Strong interpersonal and negotiation skills
  • Problem identification and solving skills
  • Competent people manager and able to identify and promote talent
  • Ability to enable and drive change
  • Able to work effectively in, spoken English (written and spoken)
  • Self-starter, able to schedule and progress workload on own
  • Experience of working with and leading cross-site and multi-functional teams
  • LI-GSK

Preferred qualifications:

  • 15+ years experience in the pharmaceutical industry
  • Fluency in Cantonese and Mandarin

Details:

In GSK Hong Kong and Macau, we have a dedicated team of about 250 people, ensuring local people have timely access to our medicines, vaccines and consumer healthcare products to help them to Do More, Feel Better and Live Longer.

Job responsibilities:

(1)Lead and develop capability of the Regulatory Affairs Team

(2)Develop Regulatory Strategy to meet business needs

(3)Ensure the Regulatory Affairs Team in providing the following services:

  • product registration and change of particulars submission
  • pack management and artwork creation
  • tender submission
  • quality-related activities
  • adverse event reporting

Part I - Product Registration and Variation

(1) New Product Registration

  • Coordinate market-specific requirements on International Registration Documents and registration strategies
  • Confirm with Global Regulatory Affairs (GRA) on documents and registration samples (if required) for submissions
  • Upon receipt of dossiers from GRA, review and prepare a local submission package to local regulatory authority (Department of Health, DoH)

(2) Change of Registered Particulars / Variations / Labelling updates

  • Receive and evaluate requests on variations or labeling updates either from global or local functions
  • Check on submission and approval timeline for variation and ensure project timeline is met
  • Upon receipt of dossiers from GRA, review and prepare a local submission package to DoH

Part II - Pack Management and Artwork Creation

(1)New Pack Request / Pack Amendment Order

  • Create and manage artwork lifecycle including any new packs or changes in current pack components
  • Manage artwork brief creation, impact assessment from LOC perspective, change request authorization, review and approve artwork activity in Global Pack Management (GPM) process
  • Liaise with the relevant manufacturing site and regional service centre on initiating any new packs or changes in current pack components if GPM process is not available

Part III – Tender

(1)Tender Preparation and Submission

  • Request supporting documents from GRA to support the tender application

Part IV – Quality Management System Related Processes

(1)Secondary Repackaging for GSK Products

  • Ensure all repackaging components comply with local regulatory requirements
  • Ensure any regulatory implications of the proposed repackaging have been assessed and addressed

(2)Batch Release

  • Ensure that the most up-to-date local registered finished specifications and the approved up-to-date artworks are shared with QA team in a timely manner for batch release checking.

(3)Management of Product Incident and Recalls

  • Provide relevant local regulatory information and guidance
  • Develop and lead any regulatory strategy that is required to manage the incident
  • Ensure the need for communication and further actions with regulatory agencies are considered and evaluated

(4)Deviation Handling

  • Seek QA guidance in order to decide whether the event is a deviation and, if confirmed, any subsequent investigation requirements.

(5)Level 1 Self-Inspection

  • Perform Level 1 Self-inspection according to schedule
  • Record self-inspection outcome

(6)Level 2 Monitoring Audit

  • Support the audit by ensuring the requested information is being provided to the audit team
  • Demonstrate positive behaviours during the course of the audit, disclosure and discuss issues and risks to the audit team for resolutions

Part V – Human Safety Related Processes

(1)Adverse Event Reporting

  • Reporting of adverse events according to company policies

Part VI - WDL and DD registration ownership

Contact information:

You may apply for this position online by selecting the Apply now button.

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