Shape the Future of Health with Biomedia Holdings
Join a leading life sciences group driving innovation in Microbiology, Oncology, and Infectious Diseases across Southeast Asia. Headquartered in Singapore, Biomedia Holdings empowers healthcare, research, and pharma sectors with cutting-edge diagnostics, therapeutics, and lab technologies.
As we expand across the region, we're looking for bold, agile professionals ready to make an impact. Be part of a team that's transforming scienceand saving lives.
This role is part of SPD Scientific (M) Sdn Bhd's Quality Assurance and Regulatory Affairs (QRA) department under the Infrastructure Management Division. As a key member of Regulatory Affairs team, the Assistant Regulatory Affairs Manager manages the Regulatory Affairs team and reports to the Manager, Quality Assurance and Regulatory Affairs (QRA). The role focuses on managing the Regulatory Team and assist/support the maintenance of product registrations including and not limited to Medical Devices, Pharmaceuticals, etc. Main responsibilities include new product registration, product re-registration, post registration maintenance, business licenses attainment and maintenance, pharmacovigilance and overall regulatory compliance. This position also oversees Quality Assurance (QA) function to ensure Quality Management System compliance and work process standardisation at local operating site with the aim of fostering a culture of compliance and continuous improvement within the organisation. This position is pivotal in advancing our business objectives to provide innovative medical solutions that meet product compliance, quality and safety.
Key Responsibilities:
Regulatory and Compliance Duties
- To oversee and track regional RA's team overall performance on business certifications and license applications and maintenance, product registrations progress and maintenance.
- To manage the overall cost and budget for business licenses and certifications and new product registration and amendments.
- To perform business permit and licenses application and conduct maintenance including renewals and amendments.
- To perform product registration, renewals and amendments for all new and existing products including Medical Devices, Pharmaceutical Poison Items etc and ensure compliance to regulatory authorities requirements.
- To lead and plan yearly pipeline registrations with Sales/BD and track ongoing registrations for regional Business Entities (BEs).
- To manage and provide consolidated monthly status updates and reports on registrations, renewals, and amendments across all regions.
- To monitor, source, and interpret new guidelines, circulars, and directives issued by regulatory authorities (local and regional) and communicate updates to internal and regional stakeholders.
- To handle regulatory enquiries and issues relating to the sales and distribution of regulated products including customer complaints, adverse events etc and follow up to closure.
Quality Assurance including Internal Process, Standardisation, and Improvement
- To lead certification, customer and supplier audits and follow up.
- To oversee and support storage and distribution services to ensure compliance with local and regional regulations
- To oversee the development, review and update of company's manuals and procedures including System Procedures, SOPs as per applicable international and local regulations and standards such as GDPMD, adhering to company's QMS requirements.
- To lead the review of current organisation processes with inter-department stakeholders and implement QRA continuous improvement projects to achieve harmonisation and standardisation.
Pharmacovigilance and Training
- To conduct Pharmacovigilance (PV) training, PV literature screening and provide relevant updates to stakeholders.
- To act as National Responsible Person for Pharmacovigilance (NRPP) as required per local PV legislation.
Qualifications and Requirements:
- Bachelor's degree in pharmacy.
- Minimum 5 years of working experience as a pharmacist and/or with proven regulatory and compliance specialisation experience in Medical Device/ Pharmaceutical or equivalent industry.
- Familiar with regulatory registration processes and requirements for Medical Devices, Scheduled Poison & Non-Scheduled Poison.
- Familiarity with ISO 9001 and GDP/GDPMD audits and compliance requirements is preferred.
- Strong leadership abilities with excellent communication and interpersonal skills, complemented by critical thinking and problem-solving capability.
- Able to understand and convey technical information to principal and other stakeholders.
- Demonstrates resilience and efficiency in managing tasks under pressure and within strict timelines.
- Works effectively both independently and as part of a team.
