- Paya Lebar Road Geylang Southeast (Singapore) Singapore
HAROLD CONSULTANCY Hiring! Full Time Regulatory Affairs Manager in Southeast (Singapore), Earn up to SGD 12,000 - Ricebowl
Regulatory Affairs Manager
HAROLD CONSULTANCY
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Job Description
Responsibilities
Job Title:
Regulatory Affairs Manager – Southeast Asia
Location:
Central, Singapore
About the Client
Our client is a pharmaceutical solutions company focused on bringing innovative medicines to emerging markets across Southeast Asia. They offer full value chain capabilities, from product registration and commercialisation to supply chain management, and serve as a strategic partner for global innovators looking to expand their presence in complex markets.
About the Role
We are seeking an experienced Regulatory Affairs Manager to lead product registration activities across Southeast Asia. This is a senior-level individual contributor role, based in Singapore, with a focus on managing regional submissions and ensuring compliance with local health authority requirements.
You will work closely with internal stakeholders and health authorities across the region to secure and maintain product registrations, support business development, and ensure regulatory compliance.
Key Responsibilities
Lead product registration and lifecycle management activities for assigned markets across Southeast Asia (Vietnam, Thailand, Indonesia, and others)
Prepare, compile, and submit regulatory dossiers in compliance with local requirements, including HSA, NPRA, BPOM, and Thai FDA
Manage end-to-end registration processes, including new product filings, renewals, variations, and post-approval changes
Serve as the primary point of contact for Health Sciences Authority (HSA) and other regulatory bodies on regulatory and quality assurance matters
Monitor regulatory changes and assess their impact on the product portfolio; communicate updates to internal stakeholders
Ensure compliance with GDP, GMP, and quality management system standards
Review and approve product labelling, packaging, and promotional materials for regulatory compliance
Maintain accurate regulatory files, submission records, and tracking systems
Manage product licenses and ensure timely renewals
Support regulatory due diligence for new business opportunities and product partnerships
Partner with internal teams including RA, QA, PV, Medical, Commercial, and Supply Chain to align regulatory activities with business objectives
Provide regulatory input on product development, new product evaluations, and launch strategies
Requirements
Essential
Bachelor's degree in Pharmacy, Life Sciences, or a related discipline
Minimum 5–7 years of regulatory affairs experience within the pharmaceutical industry
Strong knowledge of regulatory requirements in Southeast Asia, including HSA, NPRA, BPOM, and Thai FDA
Experience managing product registrations and lifecycle activities across multiple markets
Proven ability to liaise with regulatory authorities and manage submissions independently
Excellent communication, stakeholder management, and project coordination skills
Fluent in English (written and spoken)
Preferred
Registered Pharmacist with the Singapore Pharmacy Council
Experience with US, EU, or China regulatory submissions is highly desirable. Candidates with strong experience in 2–3 Southeast Asian markets will also be considered.
Experience with biologics, medical devices, or vaccines
Familiarity with ASEAN CTD, ICH guidelines, and international regulatory standards
Harold Consultancy is a dedicated recruitment agency serving Singapore's dynamic job market. We partner with both leading companies and talented individuals to build strong, successful teams across various industries.
Our mission is simple: to understand your career goals and match you with roles where you can thrive and grow. Whether you are taking your first career step or are an experienced professional seeking your next challenge, we provide personalised support throughout your job search.
We believe in a transparent, respectful, and efficient process. Our consultants take the time to listen to your aspirations, prepare you for interviews, and guide you toward opportunities that align with your skills and ambitions.
Let us help you find the role that’s right for you.
Explore current opportunities with us or submit your resume to start a conversation.
Visit:
*************
Regulatory Affairs Manager – Southeast Asia
Location:
Central, Singapore
About the Client
Our client is a pharmaceutical solutions company focused on bringing innovative medicines to emerging markets across Southeast Asia. They offer full value chain capabilities, from product registration and commercialisation to supply chain management, and serve as a strategic partner for global innovators looking to expand their presence in complex markets.
About the Role
We are seeking an experienced Regulatory Affairs Manager to lead product registration activities across Southeast Asia. This is a senior-level individual contributor role, based in Singapore, with a focus on managing regional submissions and ensuring compliance with local health authority requirements.
You will work closely with internal stakeholders and health authorities across the region to secure and maintain product registrations, support business development, and ensure regulatory compliance.
Key Responsibilities
Lead product registration and lifecycle management activities for assigned markets across Southeast Asia (Vietnam, Thailand, Indonesia, and others)
Prepare, compile, and submit regulatory dossiers in compliance with local requirements, including HSA, NPRA, BPOM, and Thai FDA
Manage end-to-end registration processes, including new product filings, renewals, variations, and post-approval changes
Serve as the primary point of contact for Health Sciences Authority (HSA) and other regulatory bodies on regulatory and quality assurance matters
Monitor regulatory changes and assess their impact on the product portfolio; communicate updates to internal stakeholders
Ensure compliance with GDP, GMP, and quality management system standards
Review and approve product labelling, packaging, and promotional materials for regulatory compliance
Maintain accurate regulatory files, submission records, and tracking systems
Manage product licenses and ensure timely renewals
Support regulatory due diligence for new business opportunities and product partnerships
Partner with internal teams including RA, QA, PV, Medical, Commercial, and Supply Chain to align regulatory activities with business objectives
Provide regulatory input on product development, new product evaluations, and launch strategies
Requirements
Essential
Bachelor's degree in Pharmacy, Life Sciences, or a related discipline
Minimum 5–7 years of regulatory affairs experience within the pharmaceutical industry
Strong knowledge of regulatory requirements in Southeast Asia, including HSA, NPRA, BPOM, and Thai FDA
Experience managing product registrations and lifecycle activities across multiple markets
Proven ability to liaise with regulatory authorities and manage submissions independently
Excellent communication, stakeholder management, and project coordination skills
Fluent in English (written and spoken)
Preferred
Registered Pharmacist with the Singapore Pharmacy Council
Experience with US, EU, or China regulatory submissions is highly desirable. Candidates with strong experience in 2–3 Southeast Asian markets will also be considered.
Experience with biologics, medical devices, or vaccines
Familiarity with ASEAN CTD, ICH guidelines, and international regulatory standards
Harold Consultancy is a dedicated recruitment agency serving Singapore's dynamic job market. We partner with both leading companies and talented individuals to build strong, successful teams across various industries.
Our mission is simple: to understand your career goals and match you with roles where you can thrive and grow. Whether you are taking your first career step or are an experienced professional seeking your next challenge, we provide personalised support throughout your job search.
We believe in a transparent, respectful, and efficient process. Our consultants take the time to listen to your aspirations, prepare you for interviews, and guide you toward opportunities that align with your skills and ambitions.
Let us help you find the role that’s right for you.
Explore current opportunities with us or submit your resume to start a conversation.
Visit:
*************
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