Remote Country Approval Specialist – Regulatory Start-Up

ThermoFisher Scientific; Singapore; Remote; SGD 90,000 - 130,000; Full time

Job summary

Thermo Fisher Scientific in Singapore seeks a Country Approval Specialist to manage local regulatory submissions in line with global strategy. You will prepare, review and coordinate submissions to authorities such as HSA and EC, and liaise with investigators and internal teams to keep timelines on track.

Role emphasizes contract and budget negotiations, cross‑functional collaboration with Legal, Clinical Operations and Finance, and ongoing regulatory compliance.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• Minimum 3-5 years of experience in clinical trial start-up, country approval, site activation, or regulatory affairs within the pharmaceutical, biotechnology, or CRO industry.
• Demonstrated experience independently managing site contract and budget negotiations.
• Experience working with multiple stakeholders across Clinical Operations, Legal, Finance, and Regulatory functions.

Responsibilities

• Prepare, review and coordinate local regulatory submissions (HSA, EC, additional national applications) in alignment with global strategy.
• Provide local regulatory strategy advice (HSA & EC) to internal clients.
• Develop and implement local submission strategy with cross-functional coordination.
• Serve as primary contact for investigators and local regulatory authorities to ensure timely submissions.
• Ensure guidelines and processes are followed for effective communications with investigators and authorities.
• Lead site contract and budget negotiations with investigative sites and institutions.
• Identify, escalate, and resolve contract, budget, and regulatory risks to avoid delays.

Skills

Stakeholder Management

Contract Negotiation

Regulatory Strategy

Communication Skills

Cross-functional Collaboration

Education

Bachelor's degree or equivalent

Tools

Microsoft Office

CTMS (Clinical Trial Management Systems)

Job description

Thermo Fisher Scientific in Singapore seeks a Country Approval Specialist to manage local regulatory submissions in line with global strategy. You will prepare, review and coordinate submissions to authorities such as HSA and EC, and liaise with investigators and internal teams to keep timelines on track.

Role emphasizes contract and budget negotiations, cross‑functional collaboration with Legal, Clinical Operations and Finance, and ongoing regulatory compliance.