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
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