Senior Global Regulatory Affairs Lead

MOLEAC PTE. LTD.; Singapore; On-site; SGD 90,000 - 180,000; Full time

Job summary

Moleac PTE. LTD. is seeking a Senior Regulatory Affairs Specialist to drive registration and ongoing compliance across international markets.

You will prepare high‑quality regulatory dossiers, provide practical guidance to internal stakeholders, and lead cross‑functional project groups to deliver timely outcomes. You will collaborate with health authorities, external partners, and internal teams to ensure alignment with regulatory requirements throughout the product lifecycle, including

Qualifications

• Bachelor's degree or higher in Pharmacy, Life Sciences, or related discipline.
• 3-5 years of hands-on Regulatory Affairs experience in pharma/herbal/traditional medicines.
• Knowledge of ICH CTD structure and dossiers.
• Familiarity with EU food supplement requirements.
• Experience across international markets.
• Fluent English and Mandarin.

Responsibilities

• Plan, prepare, review, and compile regulatory dossiers for submissions.
• Lead cross-functional regulatory project groups across Quality, Clinical, Medical, Commercial, and Supply Chain.
• Represent the company in discussions with health authorities and external partners.
• Coordinate regulatory activities across the product life cycle including variations and renewals.
• Monitor regulatory developments and maintain current regulatory records.
• Review labels and promotional materials for regulatory compliance.
• Provide regulatory support for trials and pharmacovigilance activities.

Skills

English and Mandarin proficiency

Education

Bachelor's degree in Pharmacy or Life Sciences

Job description

Moleac PTE. LTD. is seeking a Senior Regulatory Affairs Specialist to drive registration and ongoing compliance across international markets.

You will prepare high‑quality regulatory dossiers, provide practical guidance to internal stakeholders, and lead cross‑functional project groups to deliver timely outcomes. You will collaborate with health authorities, external partners, and internal teams to ensure alignment with regulatory requirements throughout the product lifecycle, including