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 crossfunctional teams.
Key Responsibilities:
- Develop and execute regional regulatory strategies for new product registrations, renewals and major postapproval 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 highquality 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 countryspecific 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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