As an Assistant Manager, Regulatory Affairs, this role will be responsible for Singapore product registration, including regulatory, quality assurance and pharmacovigilance compliance. The ideal candidate will be responsible for providing strategic regulatory inputs to the business for new product submissions and launches, accelerate regulatory submissions / approvals, product lifecycle maintenance and post-market compliance. This position also supports regulatory intelligence and due diligence projects, as and when required. The incumbent reports to the Senior Manager, Regional Regulatory Affairs.
Key Roles and Responsibilities:
- Responsible person of Singapore for regulatory, quality assurance (QA) and pharmacovigilance (PV) compliance.
- Serve as the PV back-up personnel in SciGen.
- Responsible for evaluation, compilation & preparation of registration dossiers and preparing registration applications for Singapore.
- Liaise with Health Sciences Authority (HSA) on matters pertaining to regulatory activities, licenses, permits and audits.
- Ensure compliance in accordance with the HSA standard requirements of Good Distribution Practices (GDP) and GxP.
- Support regulatory intelligence and updates of the HSA regulations.
- Support Singapore product registration feasibility assessment and due diligence evaluation.
- Partner the Business Development team in assessment of registration potential for new portfolio.
- Attend to both internal and external audits conducted by internal / external audits certification body for GDPMDS, GDP and PV-related matters for Therapeutic Products, Medical Devices, Chinese Proprietary Medicine and Health Supplements.
- PV: Maintain and manage the PV systems, including to ensure incoming PV reports are collected, documented, collated and archived for accessibility at a single point.
- QA: Create, review and update Standard Operating Procedures pertaining to QA.
- QA: Liaise with manufacturers and clients on product complaints and any other QA issues.
Requirements:
- Registered Pharmacist holding a valid Practising Certificate with the Singapore Pharmacy Council is a must.
- Minimum five (5) years of relevant experience in pharmaceutical products and medical devices registrations.
- Good knowledge of regulatory processes and requirements for new submissions, Marketing Authorisation maintenance and variation submissions.
- Proficient in Common Technical Document (CTD) requirements.
- Regional experience, preferably in Asia Pacific countries, are a plus.
- Good written and verbal communication skills in English.
- Strong problem solving and analytical skills.
- Proactive and able to work independently as well as in a team.
