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Regulatory Compliance Specialist

2 weeks ago

Hong Kong, Central and Western District, Hong Kong SAR China Chemill Pharma Ltd. Full time

Job Description:

We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Chemill Pharma Ltd. This role will be responsible for ensuring compliance with local and international regulations in the areas of pharmacovigilance, quality assurance, and regulatory affairs.

About the Role:

  • This is a mid-senior level position that requires a strong background in pharmaceutical industry, specifically in regulatory affairs, quality assurance, and pharmacovigilance.
  • The successful candidate will have excellent knowledge of local and international regulatory requirements and guidelines, as well as experience in managing regulatory submissions and interactions with health authorities.
  • A strong analytical, problem-solving, and project management skills are essential for this role.
  • The candidate must also possess excellent communication, interpersonal, and leadership skills, with fluency in English and Chinese (Cantonese and Mandarin).

Responsibilities:

  1. Supervise Pharmacovigilance (PV) activities, including submission of safety information to health authorities, literature search for safety information, PV business continuity plan, PV newcomer training, PV audit readiness, etc.
  2. Implement and maintain the pharmacovigilance system to ensure compliance with local and international regulations.
  3. Develop and implement regulatory strategies to ensure compliance with local and international regulations.
  4. Manage regulatory submissions and communicate with health authorities to ensure timely approvals.
  5. Manage Regulatory Affairs (RA), including product registration, change of particulars, preparation of tender documents, submission of periodic safety update reports, etc.
  6. Conduct product quality risk assessments and develop risk management plans.
  7. Lead the preparation and submission of regulatory dossiers for new products, variations, and renewals.
  8. Provide regulatory guidance and support to cross-functional teams.
  9. Ensure compliance with adverse event reporting requirements and manage pharmacovigilance activities.
  10. Manage quality-related investigations, deviations, and CAPAs to ensure timely resolution.
  11. Prepare and conduct internal and external quality audits to ensure compliance with regulatory requirements.