Responsibilities:

• Assists in the preparation of dossiers and submission packages for regulatory agencies.
• Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
• Tracks the status of applications under regulatory review and provides updates to all stakeholders.
•  Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
• Maintains systems to trigger and log regulatory reporting.
• Assists in the preparation and sending of post-market reports and submissions.
• Tracks and maintains files on annual licenses, registrations and listings.
• Maintains systems to track, manage and report product-associated events.
• Monitors the regulatory environment and maintains information resources.
• Researches requirements and options for regulatory submissions, approval pathways and compliance activities.
• Tracks product complaints, events and recalls.
• Assist the department head in managing Pharmacovigilance matters in accordance to corporate policy and procedures.
• Assist the department head in managing Quality Assurance matters in accordance to corporate policy and procedures.
• Co-ordinate with other internal departments to facilitate product development and sales.
• Support management by performing any other duties as assigned.

 Requirements:

• Degree holder, preferably pharmacy or biological science
• 1 -2 year experience in pharmaceutical regulatory affairs preferred
• Good command of  English and Chinese
• Planning, organizing and time management skills
• More Experience will be considered as Regulatory Affairs Executive

Interested parties, please send CV with EXPECTED SALARY by clicking "Apply Now".

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