Country Approval Specialist – Regulatory Submissions

About the role

The Country Approval Specialist ensures that all local regulatory submissions are prepared, reviewed and coordinated in line with the global submission strategy. Working from an office environment, you will act as the primary liaison between investigators, internal teams and local regulatory authorities.

Key responsibilities

• Prepare, review and submit local regulatory dossiers (HSA, Ethics Committee, gene‑therapy, viral safety, import licences).
• Provide regulatory strategy advice for HSA and EC to internal stakeholders.
• Develop and implement country‑specific submission plans and ensure alignment with global timelines.
• Serve as the main contact for investigators and regulatory bodies, managing queries and escalations.
• Coordinate with Clinical Operations, Legal, Finance and Project Management to align site start‑up activities with submission milestones.
• Lead contract and budget negotiations with investigative sites while maintaining compliance with sponsor and local regulations.
• Identify, escalate and resolve regulatory, contract or budget risks that could delay site activation.
• Prepare regulatory compliance review packages and develop country‑specific patient information sheets and informed consent forms.

Required profile

• Proven experience in preparing and managing regulatory submissions for clinical studies.
• Familiarity with Singapore’s Health Sciences Authority (HSA) and local Ethics Committee processes.
• Strong ability to coordinate cross‑functional teams and communicate with external stakeholders.
• Detail‑oriented mindset with a focus on meeting critical path timelines.

Required skills

• Regulatory submission preparation
• Regulatory strategy development
• Contract negotiation
• Budget negotiation
• Knowledge of HSA regulations
• Knowledge of Ethics Committee processes
• Patient information sheet development
• Informed consent form preparation

What we offer

• Standard Monday‑Friday office schedule
• Opportunity to work on innovative clinical projects
• Collaboration with multidisciplinary global teams