Regional Regulatory Affairs Specialist

JAC Recruitment Pte Ltd; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company is seeking a Regional RA Specialist based in Singapore. The role involves developing regulatory strategies, managing submissions, and supporting interactions with health authorities across the Asia & Arab region. Ideal candidates will have 2–5 years of regulatory affairs experience and a strong understanding of regional regulatory frameworks. This position offers a key opportunity to enhance compliance and strategic drug development initiatives.

Qualifications

• 2–5 years’ regulatory affairs experience in the pharmaceutical industry, with regional exposure in APAC preferred.
• Strong understanding of APAC/ASEAN/ICH regulatory frameworks.
• Proven ability to manage complex regulatory tasks and provide strategic input.

Responsibilities

• Develop and execute regulatory strategies for product registrations.
• Lead coordination with local affiliates for submissions and lifecycle management.
• Support interactions with Health Authorities with high-quality responses.
• Perform regulatory risk assessments and propose actionable plans.
• Monitor regulatory intelligence and share insights.

Skills

Regulatory affairs experience

Knowledge of APAC/ASEAN/ICH regulations

Ability to manage regulatory tasks independently

Experience with ASEAN CTD/eCTD modules

Job description

Overview

Job Title: Regional RA Specialist

Location: Singapore

About Us

We are partnered with a leading pharmaceutical company committed to innovative healthcare solutions across Asia. They are dedicated to enhancing patient well‑being through rigorous regulatory compliance and strategic pharmaceutical development.

They are seeking an experienced Regulatory Specialist based in Singapore to lead and support regulatory activities across the Asia & Arab region (excluding China & Japan). This role provides strategic regulatory advice, manages complex regional submissions and lifecycle activities, supports interactions with health authorities, and strengthens regulatory capability across local affiliates and cross‑functional teams.

Key Responsibilities

• Develop and execute regional regulatory strategies for new product registrations, renewals and major post‑approval changes; anticipate risks and recommend mitigation to optimize approval timelines.
• Lead coordination with local affiliates and Responsible Persons for submissions, product registrations, renewals and lifecycle management; review and validate ASEAN CTD / eCTD documentation.
• Support interactions with Health Authorities by preparing scientific justifications, briefing materials and high‑quality responses to queries.
• Perform regulatory risk assessments for submissions and variations; track risk and propose actionable mitigation plans.
• Monitor regulatory intelligence across APAC/ASEAN and the Arab region; analyze impacts and share insights to inform business decisions.

Qualifications

• 2–5 years’ regulatory affairs experience in the pharmaceutical industry, with regional exposure in APAC preferred.
• Strong understanding of APAC/ASEAN/ICH regulatory frameworks and country‑specific requirements.
• Proven ability to manage complex regulatory tasks independently and provide strategic regulatory input.
• Experience preparing or reviewing ASEAN CTD / eCTD modules and supporting Health Authority interactions.

Interested applicants, please click APPLY NOW.

Please note, only shortlisted candidates will be contacted.

JAC Recruitment Pte Ltd

EA License Number: 90C3026

EA Personnel: R2197665

#LI-JACSG

#countrysingapore