Regulatory and Compliance Duties
- Main liaison with regulatory and government bodies regarding Regulatory works including but not limited to product registrations (including LABG and its customers’ products etc), regulatory related enquiries from internal and external stakeholders and updating of regulatory requirements etc.
- Handle product registrations including review and preparation of product dossiers and both maintenance and filing of current product licenses and registration documents.
- Oversee and track overall product registrations and RA related projects for Singapore and Regional BEs.
- Handle Medical Devices, Radioactive Products, Therapeutic Products and Controlled Drugs related tasks including but not limited to its import, clearance, and release.
- Handle internal department e.g. Sales enquiries, customer enquiries and conduct customer presentations where applicable.
- Responsible for local permit and licenses application, renewals and maintenance.
- Manage variations for therapeutic products and change notifications for medical devices etc.
- Plan and coordinate regulatory and classification body audits with relevant authorities, prepare auditees and relevant documentations prior to audits and handle audit follow ups with both internal stakeholders and regulatory authorities.
- Submit reports and transactions of our companies’ assigned licenses and permits as required by respective regulatory authorities.
Internal Process, Standardisation and Improvement
- Review current RA processes and product registrations with inter-department stakeholders and implement harmonisation and alignment across Singapore and Regional BEs.
- Ensure relevancy and compliance of our Procedures (SPs/SOPs/WIs) in accordance with local regulations and certification body standards.
- Organize and lead meetings with the local and regional Regulatory Affairs team to review status of registrations, renewals and amendments including projects and other activities of the department.
- Provide monthly and quarterly RA performance reporting to Head of QRA.
- Develop yearly Regulatory budget and planning and conduct quarterly review for reporting purposes.
- Liaise with QA and Operations on the periodic and routine review of logs and records for movement and traceability of products and responsible in handling product recalls.
- Manage complaints including customer and product related complaints and handle FSCA/adverse events/CARs with both internal and external stakeholders where applicable.
Pharmacovigilance and Training
- Train both Singapore and Regional teams on the preparation of documents for license applications and maintenance including new product launches and existing products.
- Conduct Pharmacovigilance (PV) training, PV literature screening and provide relevant updates to stakeholders.
Requirements
- Diploma / Degree in Science field
- At least 3 years and above experience in relevant experience
- Must have pharmacy background
