We are seeking a highly motivated and experienced Regulatory Affairs Manager to lead and manage regulatory strategies, to ensure timely submissions, enabling timely product approvals and lifecycle management for our product portfolio in Singapore. The ideal candidate will serve as the primary point of contact for Health Sciences Authority (HSA) in all matters related to RA/QA and fostering strong collaboration with internal stakeholders.

KEY RESPONSIBILITIES

Regulatory Affairs:

• Develop and execute regulatory strategies to ensure timely product registrations, variations and renewals in Singapore.
• Prepare, compile, review, and submit regulatory dossiers in accordance with HSA requirements.
• Maintain regulatory compliance across the product lifecycle, including handling variations, labelling updates, and post-marketing requirements.
• Act as the primary liaison with HSA and other relevant regulatory bodies; manage communications and negotiations effectively.
• Monitor and interpret regulatory guideline, policies, and trends; assess impact and communicate changes to stakeholders.
• Collaborate with cross-functional teams (RA, QA, PV, Medical, Commercial, etc.) to support business objectives and ensure regulatory alignment for timely product launch and supply continuity.
• Provide regulatory input in product development, promotional material reviews, and new product evaluations.
• Maintain up-to-date regulatory files and tracking systems for all submissions and approvals.

Quality Assurance:

• Oversee local quality activities to ensure compliance with HSA's Good Distribution Practice (GDP) and other relevant guidelines.
• Maintain and update the local Quality Management System (QMS), including SOPs and records.
• Ensure timely reporting and resolution of quality incidents, product complaints, and deviations.
• Coordinate with global QA for quality audits, inspections, and CAPA implementation.
• Ensure compliance with local pharmacovigilance 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 and when assigned by the Company.

QUALIFICATIONS / REQUIREMENTS

Knowledge/Experience:

• Must be a licensed pharmacist in Singapore.
• Bachelor's degree in Pharmacy, Life Sciences, or a related field. Advanced degree is a plus.
• Minimum 7-10 years of regulatory affairs experience in the pharmaceutical, biotech, medical device or healthcare industry, preferably within Singapore.
• Strong knowledge of HSA regulations and regulatory submission requirements including RA, GDP and PV.
• Proven experience in leading product registrations and acting as the primary contact for HSA.
• Excellent communication, and ability to collaborate across cross-functional teams.
• High level of integrity, detail-orientation, and critical thinking skills.
• Ability to work independently and manage multiple projects in a dynamic environment.

Preferred Qualifications:

• In-depth knowledge of HSA drug and medical device regulatory processes and regulations, ASEAN and ICH guidelines, and international regulatory standards.
• Previous experience of verification pathway, ACCESS or Project orbis would be preferred.
• Experience with digital regulatory tools and quality systems is a plus.
• Membership or certification in professional bodies such as RAPS, SAPI, ISPE, or similar is desirable.
• Proficiency in English (written and spoken) is a must. Fluency in Mandarin (written and spoken) is a plus.