About the job
Job Purpose
Our client in the pharmaceutical industry is seeking to recruit a Drug Registration Assistant, who will play a crucial role in ensuring that the pharmaceutical products meet all necessary regulatory requirements. The assistant, in liaison with the Regulatory Pharmacist, will be in the forefront of securing and maintaining the necessary approvals and licenses for a diverse range of medications. The successful incumbent will play a key role in the smooth operation of the registration processes.
Duties and Responsibilities:
- Ensure SPKL’s PPB licenses are renewed annually in a timely manner
- Ensure timely follow-up on laboratory analysis documents, and forward quotations to the client for approval prior to submitting samples for analysis
- Submit registration dossiers and product variations through the PPB portal on behalf of clients
- Communicate with international suppliers, sending reminders and follow-ups regarding Pharmacovigilance and PPB communications
- Take responsibility for following up on payment for product registration, variations, medical devices registration, and product retentions at PPB, collaborating with the finance department and external clients
- Ensure the registration samples stock is updated in a timely and accurate manner
- Send monthly updates to clients regarding the registration status
- Maintain regular and accurate filing of documents in the respective client files
- Upload disposal products on the Pharmacy and Poisons Board (PPB) portal
- Assist in compiling and submitting accurate and timely drug registration applications
- Conduct comprehensive research on local and international regulatory guidelines, providing compliance advice for all markets
- Assist in preparing and maintaining registration dossiers, including technical documentation and manufacturing data
- Stay informed about changes in regulations, guidelines, and industry best practices, and provide recommendations to enhance compliance
- Maintain meticulous records and databases, ensuring that all information is up-to-date and easily accessible for audits and reporting purposes
Key Skills and Competencies:
- Diploma in Pharmacy, Pharmaceutical Sciences, or a related field
- Solid understanding of drug registration processes and regulatory frameworks
- Excellent organizational skills with an impeccable attention to detail
- Strong communication and interpersonal abilities
- Familiarity with relevant software and databases
- Willing to learn and someone who can adapt to an ever changing work environment
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