Regulatory Affairs Manager

HAROLD CONSULTANCY; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

HAROLD CONSULTANCY seeks an experienced Regulatory Affairs Manager to lead product registration activities across Southeast Asia from Singapore. Based in Singapore, you will manage regional submissions and ensure compliance with local health authority requirements.

You will work with internal stakeholders to secure registrations, support business development, and maintain regulatory compliance across markets in SEA.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, or related field.
• 5–7 years of regulatory affairs experience in the pharmaceutical industry.
• Knowledge of regulatory requirements in Southeast Asia (HSA, NPRA, BPOM, Thai FDA).
• Experience managing product registrations and lifecycle activities across multiple markets.
• Fluent in English (written and spoken).

Responsibilities

• Lead product registrations and lifecycle management in Southeast Asia.
• Prepare, compile, and submit regulatory dossiers per local requirements.
• Manage end-to-end registration processes including renewals and variations.
• Liaise with regulatory authorities such as HSA, NPRA, BPOM, and Thai FDA.
• Monitor regulatory changes and communicate impacts to stakeholders.
• Ensure compliance with GDP, GMP, and quality systems.

Skills

Regulatory affairs

Stakeholder management

English proficiency

Project coordination

Education

Bachelor's degree in Pharmacy/Life Sciences

Tools

Regulatory databases

Job description

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