Job Description
Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regional Regulatory Senior Specialist headquartered in Singapore to support and lead regulatory initiatives throughout Asia and the Middle East area (excluding China and Japan). This position necessitates strong regulatory judgment, the ability to provide professional advice, and assistance in formulating regulatory plans for the region. The Specialist will manage more difficult regulatory activities autonomously, guide local corporate representatives (Responsible Persons), facilitate early interactions with authorities, and contribute to risk assessment and mitigation planning. You will be reporting to the team leader (Singapore).【 Responsibilities 】1) Regional Regulatory Strategy & Professional Advice-Provide professional advice on complex regulatory matters, including pathway expectations, data requirements, and regulatory classifications. - Support the development of regional regulatory strategies for new product registrations, renewals, and significant post-approval changes. - Anticipate regulatory risks and challenges, offering strategic recommendations to optimize approval timelines and compliance outcomes. 2) Regulatory Coordination & Lifecycle Management- Lead coordination with local companies and Responsible Persons for submissions, product registrations, renewals, and lifecycle management activities. - Review and validate regulatory documentation (e.g., ASEAN CTD, eCTD modules) prepared for local partners, ensuring completeness and alignment with market requirements. - Oversee the preparation of post-approval change applications, ensuring regulatory robustness and timely execution. 3) Health Authority Interaction Support- Provide professional support for inquiries and preliminary consultations with local Health Authorities, including preparation of scientific justifications and briefing materials. - Work closely with Responsible Persons to ensure consistent regulatory positions and high-quality responses to HA queries. 4) Training & Development- Provide training and technical support to local Responsible Persons & other internal functional teams on regional regulatory processes. - Develop and refine templates, training materials, and guidance documents to enhance regulatory capability across the region. 5) Regulatory Intelligence & Research- Conduct in-depth research and analysis on regulatory updates and emerging trends in the region. - Share insights through presentations during team meetings to support strategic decision-making. - Monitor evolving regulations and assess potential impacts on products, submissions, and business operations 6) Regulatory Risk Assessment & Mitigation- Perform regulatory risk assessments for new submissions and variations and monitor risk throughout the progress of the applications. - Identify potential regulatory challenges early and propose actionable countermeasures and mitigation strategies to reduce regulatory exposure and ensure business continuity. 7) Cross-Functional & Regional Collaboration- Collaborate with internal stakeholders located in the Overseas Regulatory Office (CMC, Support & Promotion Team and Labelling) as well as cross-functional teams including Business, Quality Assurance and Pharmacovigilance to ensure alignment of regulatory requirements. - Act as a regional regulatory subject matter resource for internal teams, offering clarity on RA internal processes - Foster effective communication between global, regional, and local regulatory teams. 8) Documentation & Systems- Support local companies and their designated Responsible Persons to ensure accurate and timely maintenance of regulatory records, correspondence, approvals, and commitments within electronic systems. - Support continuous improvement of regulatory documentation practices and tools.
Benefit
【 What you will receive 】
- AWS
- Variable Bonus, subject to company and individual performance
- Annual Leave: 14 days
- Medical Leave
- Medical Benefits
- Flexible Benefits: up to S$1,500 per year
- Work Arrangement: Hybrid work arrangement (office-based once a week). Additional work-from-home arrangement available on other working day.