FSP Country Approval Specialist – All Level

This is a fully remote position, open to applicants in Singapore.

📋 Description

• Prepare, review, and coordinate local regulatory submissions, which include HSA, EC, gene therapy approvals, viral safety dossiers, and import licenses as necessary.

• Provide local regulatory strategy guidance to internal clients.

• Develop and execute local submission strategies.

• Offer technical expertise and coordination oversight in collaboration with internal departments.

• Act as the primary liaison for investigators and local regulatory authorities.

• Ensure adherence to regulatory guidelines, processes, and communications.

• Serve as the key country-level contact for submission-related activities.

• Engage in submission, review, and project team meetings.

• Coordinate site start-up activities with internal functional departments, aligning them with submission timelines and critical paths.

• Lead negotiations regarding site contracts and budgets with investigative sites and institutions.

• Independently handle complex contract and budget negotiations.

• Collaborate with Legal, Clinical Operations, Project Management, and Finance to resolve issues related to contracts and budgets.

• Identify, escalate, and proactively address contract, budget, and regulatory risks.

• Ensure that country submission activities remain on the critical path and meet target cycle times.

• Prepare regulatory compliance review packages.

• Coordinate local submission activities in line with the global project submission strategy.

• Develop country-specific Patient Information Sheets and Informed Consent Forms.

• Assist with negotiations related to grant budgets and payment schedules.

• Identify local out-of-scope contract activities and provide advice to relevant functions.

• Support feasibility activities.

• Maintain accurate and up-to-date trial status information in the database.

• Oversee country study files and ensure compliance with PPD WPD or client SOPs.

• Stay informed about PPD SOPs, client SOPs/directives, and current regulatory guidelines.

• Direct or mentor SIA individuals assigned to projects.

• Identify, resolve, or escalate regulatory process issues and anomalies.

• Collaborate with global project teams across various time zones.

⛳️ Requirements

• Bachelor's degree or equivalent relevant formal academic/vocational qualification.

• A minimum of 3-5 years of experience in clinical trial start-up, country approval, site activation, or regulatory affairs within the pharmaceutical, biotechnology, or CRO industry.

• Proven experience in independently managing site contract and budget negotiations.

• Experience collaborating with diverse stakeholders across Clinical Operations, Legal, Finance, and Regulatory functions.

• Strong background in site contract and budget negotiations with hospitals and investigative sites.

• Comprehensive understanding of clinical trial agreements, site budget development, and negotiation strategies.

• Effective oral and written communication skills.

• Excellent interpersonal abilities.

• Strong attention to detail and documentation quality.

• Good negotiation capabilities.

• Proficient computer skills and the capacity to learn relevant software.

• Sound judgment and decision-making abilities.

• Basic knowledge of medical/therapeutic areas and medical terminology.

• Ability to work collaboratively in a team environment or independently, with minimal supervision as needed.

• Capacity to mentor fellow SIA team members positively and effectively.

• Strong team player with team-building skills.

• Basic organizational and planning abilities.

• Excellent knowledge of applicable regional/national regulatory guidelines and EC regulations.

• Proficiency in Microsoft Office and clinical trial management systems.

• Must be based in Singapore.

• In certain cases, equivalent combinations of education, training, and/or directly related experience may be considered sufficient.

🏝️ Benefits

• Fully remote position based in Singapore.

• Occasional travel may be required for investigator meetings, sponsor meetings, or business needs.

• Work is primarily conducted in a home office environment.

• Standard office equipment will be utilized in accordance with company policies.

• Collaboration and development are integral to the everyday experience.

• Global team environment.

• Standard (Mon-Fri) work schedule.