Country Approval Specialist

Role overview

The Country Approval Specialist is responsible for preparing, reviewing, and coordinating country-level submissions in line with the overall global submission plan. The role plays a central part in site activation and trial start-up activities, with a strong focus on regulatory coordination, contract and budget negotiations, and cross-functional alignment.

Key responsibilities

• Prepare, review, and coordinate local regulatory submissions, including HSA, EC, and other country-specific filings such as gene therapy approvals, viral safety dossiers, and import licences, in accordance with the global submission strategy.
• Advise internal stakeholders on local regulatory strategy for HSA and/or EC requirements.
• Build and execute local submission plans, offering technical input and coordination support across relevant internal teams.
• Act as the main point of contact for investigators and local regulatory authorities, and work with the local regulatory manager on complex matters so submissions progress without delay.
• Make sure internal communication, investigator communication, and authority communication follow the required guidelines and processes to keep submissions moving on schedule.
• Serve as the country-level lead contact for all submission-related work.
• Take part in submission team meetings, review meetings, and project team meetings when needed.
• Coordinate with internal departments to align site start-up tasks with submission milestones and agreed timelines, ensuring the submission path supports critical site activation dates.
• Lead contract and budget discussions with sites and institutions, ensuring timely agreement while meeting sponsor expectations, local legal requirements, and company standards.
• Handle complex contract and budget negotiations independently, balancing study timelines, financial goals, and site relationship management.
• Work with Legal, Clinical Operations, Project Management, and Finance to resolve issues that may affect contracts, budgets, or timelines.
• Spot, escalate, and help resolve regulatory, contract, and budget risks that could slow site activation.
• Keep country submission activities on the critical path for study start-up and support target cycle times.
• Prepare regulatory compliance review packages where required.
• Coordinate locally within SIA so submission activities are planned and delivered according to the global project submission strategy.
• Draft country-specific Patient Information Sheets and Informed Consent Forms.
• May support grant budget and payment schedule discussions with sites.
• Identify out-of-scope contract activities early and notify the relevant teams.
• Support feasibility coordination as needed within agreed timelines.
• Ensure trial status information related to SIA activities is kept accurate and up to date in the database.
• Oversee country study files and ensure they comply with PPD WPD or client SOP requirements.
• Maintain working knowledge of PPD SOPs, client SOPs/directives, and relevant regulatory guidelines.
• Guide and mentor other SIA team members supporting assigned projects, where appropriate.
• Proactively detect process issues or irregularities in study regulatory workflows and resolve or escalate them as needed.

Requirements

• Bachelor’s degree or an equivalent combination of academic, vocational, training, and directly related experience.
• At least 3–5 years of experience in clinical trial start-up, country approval, site activation, or regulatory affairs in the pharmaceutical, biotechnology, or CRO sector.
• Proven ability to independently manage site contract and budget negotiations is required.
• Experience collaborating with Clinical Operations, Legal, Finance, and Regulatory teams.
• Strong knowledge of clinical trial agreements, site budget development, and negotiation methods.
• Clear verbal and written communication skills.
• Strong interpersonal ability and a detail-oriented approach to documentation quality.
• Sound negotiation, judgment, and decision-making skills.
• Comfortable using computers and learning new software tools.
• Basic understanding of medical/therapeutic areas and medical terminology.
• Ability to work independently or within a team with minimal supervision.
• Capability to mentor colleagues in a constructive and effective manner.
• Good teamworking and collaboration skills.
• Basic planning and organisational ability.
• Strong knowledge of relevant regional and national regulatory guidelines and EC regulations.
• Proficiency with Microsoft Office and clinical trial management systems.

Working conditions

• This role is fully remote and based in Singapore.
• Standard work schedule is Monday to Friday.
• The role is primarily carried out in a home office setting.
• Regular interaction with global project teams across multiple time zones is expected.
• Occasional travel may be required for investigator meetings, sponsor meetings, or other business needs.
• Standard office equipment will be used in line with company policies.
• Environmental condition: office.

Why this role

You will join a global scientific organisation where collaboration, innovation, and professional growth are part of everyday work. The role offers the chance to contribute directly to study start-up success and help advance important scientific programmes.