Chemill Pharma Ltd. | Regulatory
6 days ago
- 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.
Mid-Senior Level
Employment TypeFull-time
Job FunctionLegal
IndustriesPharmaceutical Manufacturing
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