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Regulatory / Pharmacovigilance/ Quality assurance

2 weeks ago

Hong Kong, Central and Western District, Hong Kong SAR China Chemill Pharma Ltd. Full time
Regulatory / Pharmacovigilance/ Quality Assurance
  • Supervise Pharmacovigilance (PV), including submission of safety information to health authorities, literature search for safety information, PV business continuity plan, PV newcomer training, PV audit readiness, etc.
  • Implement and maintain the pharmacovigilance system to ensure compliance with local and international regulations.
  • Develop and implement regulatory strategies to ensure compliance with local and international regulations.
  • Manage regulatory submissions and communicate with health authorities to ensure timely approvals.
  • Manage Regulatory Affairs (RA), including product registration, change of particulars, preparation of tender documents, submission of periodic safety update reports, etc.
  • Conduct product quality risk assessments and develop risk management plans.
  • Lead the preparation and submission of regulatory dossiers for new products, variations, and renewals.
  • Provide regulatory guidance and support to cross-functional teams.
  • Ensure compliance with adverse event reporting requirements and manage pharmacovigilance activities.
  • Manage quality-related investigations, deviations, and CAPAs to ensure timely resolution.
  • Prepare and conduct internal and external quality audits to ensure compliance with regulatory requirements.

Requirements:

  • Bachelor's degree in pharmacy or related field. Advanced degree is a plus.
  • Minimum 3 years of experience in regulatory affairs, quality assurance, and pharmacovigilance in the pharmaceutical industry.
  • Strong knowledge of local and international regulatory requirements and guidelines.
  • Experience in managing regulatory submissions and interactions with health authorities.
  • Familiarity with GMP, GDP, and other relevant quality standards.
  • Experience in managing pharmacovigilance related regulations and adverse event reporting.
  • Strong analytical, problem-solving, and project management skills.
  • Excellent communication, interpersonal, and leadership skills.
  • Fluent in English and Chinese (Cantonese and Mandarin).
  • Ability to work independently and in a team environment.
Seniority Level

Mid-Senior Level

Employment Type

Full-time

Job Function

Legal

Industries

Pharmaceutical Manufacturing

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