Medical Affairs & Responsible Person (TPIL) Manager
Weare seeking a Singapore Registered Pharmacist to support both Medical Affairsand Quality & Regulatory responsibilities. The role will primarily functionas a Medical Science Liaison (MSL) for the Singapore market and provide MedicalAffairs support across Regional Overseas (ROW) markets. In addition, theincumbent will serve as the Responsible Person (RP) under the TherapeuticProducts Import Licence (TPIL), ensuring compliance with HSA regulations andGood Distribution Practice (GDP) requirements for the importation anddistribution of therapeutic products.
Medical Affairs
1. Serve as the Medical Science Liaison (MSL) for the Singapore market, providing scientific and medical support for the company's products, while ensuring all activities comply with applicable regulations and company policies.
2. Build and maintain professional relationships with healthcare professionals (HCPs) and key opinion leaders (KOLs).
3. Provide timely, accurate and balanced scientific responses to medical enquiries from healthcare professionals, internal stakeholders and business partners.
4. Review medical and promotional materials from a scientific perspective to ensure medical accuracy, compliance and consistency with approved product information.
5. Collaborate closely with Commercial, Regulatory Affairs, Supply Chain and other cross-functional teams by providing scientific expertise to support business objectives while maintaining compliance.
Responsible Person
1. Act as the designated Responsible Person (RP) under the TPIL, holding personal accountability for regulatory compliance with HSA requirements.
2.Serve as the primary point of contact for all queries, submissions, and correspondence raised to or by HSA, including licence renewals, variations, and audits.
3.Oversee compliance with Good Distribution Practice (GDP) requirements throughout the importation, storage and distribution of therapeutic products, ensuring product quality, integrity and traceability across the supply chain.
4. Develop, implement, and maintain SOPs, quality systems, and compliance documentation in line with HSA and GDP requirements.
5.Conduct or coordinate internal quality audits and inspections, and manage deviations, corrective and preventive actions (CAPA), product complaints and recalls, ensuring timely reporting to HSA where required.
6. Work closely with warehouse, logistics and supply chain partners to ensure GDP compliance, oversee supplier quality where applicable, maintain staff GDP training, and monitor changes in HSA regulations by providing timely compliance advice to internal stakeholders.
Qualifications / Requirements
1. Bachelor's degree or above in Pharmacy,Clinical Pharmacy, Pharmaceutical Sciences, Medicine, Life Sciences or otherrelated disciplines.
2.Registered Pharmacist with theSingapore Pharmacy Council (SPC), eligible to act as the Responsible Person(RP) under the Therapeutic Products Import Licence (TPIL).
3.Good knowledge of Singaporepharmaceutical regulations, Good Distribution Practice (GDP) and QualityManagement Systems (QMS), with a minimum of 5–8 years of relevant experience inMedical Affairs, Medical Science Liaison (MSL), Clinical Pharmacy or otherrelated pharmaceutical functions.
4.Prior experience in Quality Assurance (QA) or a relatedquality/compliance function within the pharmaceutical, healthcare, or lifesciences sector.
5. Practical exposure to GoodDistribution Practice (GDP) operations, including storage, transportation, andwarehousing of therapeutic products.
6. Proven ability to manage licensing, quality, and logistics functionsconcurrently, with strong organisational and documentation skills.
7. Fluent in English and Chinese,with the ability to communicate effectively with European and Chinese partners both verbally and in writing.