Pharmaceuticals
about the company
Headquartered in Singapore, my client is a leading healthcare company specializing in supporting businesses to expand across emerging markets. Through tailored commercial solutions, the company partners with healthcare organizations across multiple therapeutic areas to drive growth, market penetration, and long-term success.
about the job
We are seeking a highly motivated and experienced Regulatory Affairs Manager( Licensed Pharmacist) to lead and execute regulatory strategies that support timely product approvals and efficient lifecycle management for our product portfolio in Singapore.
The successful candidate will serve as the primary liaison with the Health Sciences Authority (HSA), ensuring compliance with local regulatory requirements and maintaining strong, collaborative relationships with internal stakeholders across functions.
about the manager/teamThis role will report into the Head of Regulatory Affairs for APAC
skills and experience required
Regulatory Affairs- Develop and execute effective regulatory strategies to ensure timely product registrations, variations, and renewals in Singapore.
- Prepare, compile, review, and submit regulatory dossiers in full compliance with Health Sciences Authority (HSA) requirements.
- Maintain regulatory compliance throughout the product lifecycle, including the management of variations, labeling updates, and post-marketing commitments.
- Act as the primary liaison with HSA and other relevant regulatory bodies, managing all communications and negotiations professionally and effectively.
- Monitor, interpret, and communicate changes in regulatory guidelines, policies, and trends; assess their impact and advise internal stakeholders accordingly.
- Collaborate with cross-functional teams (Regulatory Affairs, Quality Assurance, Pharmacovigilance, Medical Affairs, Commercial, etc.) to support business objectives and ensure regulatory alignment for timely product launches and uninterrupted supply.
- Provide regulatory input during product development, promotional material reviews, and evaluations of new products.
- Maintain accurate and up-to-date regulatory documentation, databases, and tracking systems for all submissions and approvals.
- Oversee local quality activities to ensure full compliance with HSA’s Good Distribution Practice (GDP) guidelines and other applicable standards.
- Maintain and update the local Quality Management System (QMS), including standard operating procedures (SOPs) and relevant records.
- Ensure timely investigation, reporting, and resolution of quality-related incidents, product complaints, and deviations.
- Coordinate with global Quality Assurance teams to support audits, regulatory inspections, and implementation of corrective and preventive actions (CAPAs).
- Ensure compliance with local pharmacovigilance (PV) requirements, including timely reporting of adverse events (AEs), serious adverse events (SAEs), and product quality complaints to HSA.
- Perform any other ad-hoc duties as assigned by the company to support regulatory and quality operations.
(EA: 94C3609/ CEI:R1220560 )
show more- experience
- skills
- qualifications
Registered Pharmacist, to be based in Singapore, overseeing Singapore market.
Therapeutics Registration Experience with HSA- education
Bachelor Degree
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