Senior Regulatory Affairs Specialist

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, provides practical regulatory guidance to internal stakeholders, and helps deliver projects throughout the product life cycle.

The successful candidate will be a trusted and collaborative partner who communicates clearly, builds constructive working relationships within the Regulatory Affairs team and across functions, and can lead cross-functional project groups toward agreed outcomes. The role also represents and advocates for the company's regulatory position professionally and credibly with external partners, consultants, and health authorities.

Key Responsibilities

• Regulatory strategy and submissions: Plan, prepare, review, and compile accurate, well-structured dossiers for new registrations, variations, renewals, and other regulatory submissions. Ensure consistency across technical documents and compliance with applicable requirements and good documentation practices.

• Cross-functional project leadership: Lead or coordinate regulatory project groups involving Quality, Clinical, Medical, Commercial, Supply Chain, and other functions. Establish clear deliverables, track milestones, identify regulatory risks, facilitate decisions, and follow through on agreed actions.

• Regulatory representation and advocacy: Represent the company in discussions with health authorities, ethics committees, distributors, regulatory consultants, contract manufacturers, and other external stakeholders. Communicate the company's position clearly and support it with sound scientific and regulatory rationale.

• Global coordination and stakeholder management: Build productive working relationships with international partners and local agents. Provide clear instructions, review local requirements and submissions, resolve questions promptly, and align activities with business priorities and timelines.

• Product life-cycle management: Coordinate regulatory activities throughout the product life cycle, including variations, renewals, labelling updates, change assessments, commitments, and maintenance of marketing authorisations or equivalent approvals.

• Regulatory compliance and intelligence: Monitor relevant regulatory developments, including requirements applicable to pharmaceutical products, herbal or traditional medicines, and food supplements. Assess business impact, maintain current regulatory records, and recommend proportionate actions.

• Promotional and labelling review: Review product labels, packaging, claims, and promotional materials for consistency with approved product information and applicable regulatory requirements.

• Clinical, safety, and quality support: Where assigned, provide regulatory support for clinical trial and ethics submissions, pharmacovigilance activities, product complaint assessment, audits, inspections, and inspection readiness.

• Document quality and records: Perform meticulous quality checks to confirm that submissions and supporting records are complete, accurate, traceable, and internally consistent. Maintain well-organised regulatory files and databases.

Qualifications and Experience

• 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.

Core Competencies

• Excellent communication and relationship-building skills, with the maturity to work constructively with colleagues, partners, and external stakeholders.

• Able to lead cross-functional project groups, create alignment, manage competing viewpoints, and keep work progressing toward agreed outcomes.

• A collaborative team player who shares knowledge, listens to others, and is open to learning from colleagues in a respectful and amicable manner.

• Strong initiative and ownership, with are sourceful and solution-oriented approach to investigating and resolving issues.

• Meticulous and disciplined in reviewing technical information, identifying inconsistencies, and maintaining high documentation standards.

• Able to plan and prioritise multiple assignments, work independently, and remain dependable in a dynamic international environment.

Additional Experience That Would Be Advantageous

• Regulatory experience with clinical trial applications and submissions to ethics committees or institutional review boards.

• Experience supporting pharmacovigilance activities and product complaint handling or investigation.

• Experience working with global partners, distributors, contract manufacturers, or regulatory consultants.

• Working knowledge of GMP, GDP, and relevant quality systems.