Senior Regulatory Affairs Specialist

About the role

The Senior Regulatory Affairs Specialist supports the registration and ongoing compliance of Moleac's products across international markets. The role prepares and maintains high-quality regulatory dossiers, gives practical regulatory guidance to internal stakeholders, and helps deliver projects throughout the product life cycle. It also involves representing the company's regulatory position with external partners, consultants and health authorities.

Key responsibilities

• Plan, prepare, review and compile accurate, well-structured dossiers for new registrations, variations, renewals and other submissions, ensuring consistency and compliance with good documentation practices.
• Lead or coordinate regulatory project groups with Quality, Clinical, Medical, Commercial, Supply Chain and other functions, tracking milestones and regulatory risks.
• Represent the company with health authorities, ethics committees, distributors, consultants and contract manufacturers, supported by sound scientific and regulatory rationale.
• Coordinate regulatory activities across the product life cycle, including variations, renewals, labelling updates, change assessments and marketing authorisation maintenance.
• Monitor regulatory developments for pharmaceutical products, herbal or traditional medicines and food supplements, and assess their business impact.
• Review labels, packaging, claims and promotional materials for consistency with approved product information.
• Provide regulatory support for clinical trial and ethics submissions, pharmacovigilance, complaints, audits and inspections where assigned.
• Perform quality checks on submissions and records, and maintain well-organised regulatory files and databases.

Required profile

• 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.
• Fluent spoken and written English and Mandarin.
• Experience supporting product registrations and life-cycle activities across one or more international markets.

Required skills

• Practical knowledge of ICH requirements and the Common Technical Document structure, with experience preparing, reviewing or maintaining regulatory dossiers.
• Familiarity with EU food supplement requirements on ingredients, botanicals, labelling and claims.
• Ability to lead cross-functional project groups and communicate technical and regulatory matters clearly.

Advantageous: experience with clinical trial applications, ethics committee submissions, pharmacovigilance, product complaints, global partners, distributors, contract manufacturers and regulatory consultants; working knowledge of GMP, GDP and quality systems.