Senior Regulatory Affairs Lead – Global Submissions

Moleac Pte Ltd; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

Moleac Pte Ltd in Singapore seeks a Senior Regulatory Affairs Specialist to lead regulatory submissions and lifecycle activities for international markets. You will prepare dossiers, coordinate cross-functionally with Quality, Clinical, Medical, and Commercial teams, and advocate regulatory positions with health authorities and partners.

The role demands strong knowledge of ICH CTD, EU herbal/traditional medicine considerations, and fluency in English and Mandarin to communicate complex

Qualifications

• Bachelor's degree or higher in Pharmacy, Life Sciences, or a related discipline.
• Three to five years of hands‑on Regulatory Affairs experience in a pharmaceutical, herbal medicine, traditional medicine, or closely related regulated-product environment.
• Practical knowledge of ICH requirements and the Common Technical Document structure, with experience preparing, reviewing, or maintaining regulatory dossiers.
• Familiarity with European Union food supplement requirements, including requirements relevant to ingredients, botanicals, labelling, and claims.
• Experience supporting product registrations and life-cycle activities across one or more international markets.
• Fluent spoken and written English and Mandarin, with the ability to communicate technical and regulatory matters clearly to different audiences.

Responsibilities

• Plan, prepare, review, and compile accurate regulatory dossiers for new registrations, variations, renewals, and other submissions.
• Lead or coordinate regulatory project groups involving Quality, Clinical, Medical, Commercial, Supply Chain, and other functions.
• Represent the company in discussions with health authorities, ethics committees, distributors, regulatory consultants, and external partners.
• Build productive working relationships with international partners and local agents; align with business priorities and timelines.
• Coordinate regulatory activities throughout the product life cycle, including variations, renewals, and labelling updates.
• Monitor regulatory developments and maintain current regulatory records; recommend proportionate actions.
• Review product labels and promotional materials for regulatory compliance.
• Provide regulatory support for clinical trials, pharmacovigilance activities, and audits as needed.
• Maintain well-organised regulatory files and databases.

Skills

Regulatory affairs

Dossier preparation

Cross-functional leadership

Regulatory strategy

Regulatory submissions

English and Mandarin

Education

Bachelor’s degree in Pharmacy or Life Sciences

Job description

Moleac Pte Ltd in Singapore seeks a Senior Regulatory Affairs Specialist to lead regulatory submissions and lifecycle activities for international markets. You will prepare dossiers, coordinate cross-functionally with Quality, Clinical, Medical, and Commercial teams, and advocate regulatory positions with health authorities and partners.

The role demands strong knowledge of ICH CTD, EU herbal/traditional medicine considerations, and fluency in English and Mandarin to communicate complex