Country Approval Specialist

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

📋 Description

• Prepare, assess, and coordinate local regulatory submissions in accordance with the global submission strategy.

• Offer local regulatory strategy guidance to internal stakeholders under supervision.

• Provide and oversee project-specific local SIA services.

• Reach out to investigators for submission-related tasks as necessary.

• Act as the primary country-level contact for ethical or regulatory submission processes.

• Collaborate with internal departments on site initiation activities and submission timelines.

• Ensure that submission procedures align with critical paths for site activation.

• Meet target cycle times for sites.

• Work alongside start-up CRAs on regulatory compliance review packages as applicable.

• Create country-specific Patient Information Sheets/Informed Consent forms as required.

• Assist in negotiating grant budgets and payment schedules with sites.

• Support feasibility assessments according to established timelines.

• Enter and update trial status information in PPD tracking databases.

• Prepare, organize, and maintain local country study files and filing systems.

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

⛳️ Requirements

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

• At least 2 years of comparable experience.

• Proficient oral and written communication abilities.

• Exceptional interpersonal skills.

• Strong attention to detail and quality of documentation.

• Competent negotiation skills.

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

• Good command of the English language and grammar.

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

• Ability to work collaboratively in a team setting or independently, as directed.

• Basic organizational and planning capabilities.

• Fundamental understanding of applicable regional/national regulatory guidelines and EC regulations.

• Equivalency may include relevant education, training, and/or closely related experience.

• Capability to work in office/laboratory and/or clinical settings.

• Ability to utilize required personal protective equipment.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Supportive work environment with a focus on teamwork and collaboration.