Regulatory Affairs Manager

Overview: We are seeking an experienced Regulatory Affairs Manager to support the Neuroscience, Eye Care and Specialty portfolio across the JAPAC region (Australia, China, Japan and Asia). This role serves as a key regulatory representative, partnering with affiliate regulatory teams, commercial stakeholders and global product teams to develop regulatory strategies, support product registrations, maintain compliance and enable successful product launches across multiple markets.

Location: Singapore

Key Responsibilities:

Regulatory Strategy & Product Registration

• Develop and implement regional regulatory strategic and tactical plans for assigned products across the JAPAC region.
• Support registration activities and provide strategic regulatory guidance throughout the product lifecycle.
• Assess submission, approval and launch feasibility across different markets.

Stakeholder Management

• Act as the primary interface with affiliate Regulatory Affairs teams across JAPAC.
• Partner closely with commercial, R&D, CMC and cross-functional teams to support business objectives while ensuring regulatory compliance.
• Represent regional regulatory requirements and interests within global regulatory product teams.

Health Authority & Regulatory Engagement

• Support interactions with local health authorities through affiliate regulatory teams.
• Assist affiliates in securing timely approvals for registrations and clinical trial activities.

Compliance & Regulatory Intelligence

• Monitor changes in the regional regulatory environment and emerging policies.
• Evaluate business impacts of regulatory changes and recommend appropriate mitigation strategies.
• Ensure regulatory compliance for assigned products and implement corrective actions where required.

Regional Support & Leadership

• Support training programmes and regulatory initiatives across JAPAC affiliates.
• Provide regulatory expertise and strategic input to regional brand teams and business stakeholders.

Requirements:

• Bachelor's degree in pharmacy, Pharmacology, Biology, Life Sciences or a related scientific discipline.
• Minimum 5 years of Regulatory Affairs experience within the pharmaceutical, biotechnology or healthcare industry.
• At least 3 years of experience supporting Regulatory Affairs activities across the JAPAC region.
• Strong knowledge of regulatory requirements across multiple JAPAC markets.
• Excellent communication, stakeholder management and negotiation skills.
• Proven ability to identify regulatory risks and develop practical mitigation strategies.
• Ability to work effectively in a cross-functional and international environment.

Preferred Skills:

• Experience within multinational pharmaceutical or biotechnology organisations.
• Knowledge of Neuroscience, Eye Care and Specialty therapeutic areas.
• Product registration, lifecycle management and regulatory strategy experience.
• Familiarity with regulatory frameworks across Asia Pacific markets.

We regret to inform that only shortlisted candidates will be notified.

Job Reference: R25150511 Cammy Li Xin Hui

Allegis Group Singapore Pte Ltd, Company Reg No. 200909448N, EA License No. 10C4544