Clinical Study Startup and Regulatory Executive/Manager

Company Description

Expecto Health Science is a leading Clinical Research Organization based in Singapore, specializing in Clinical Development, Data Management, Medical Writing, Regulatory, and Pharmacovigilance services in the Asia Pacific Region. The company offers tailored solutions to a diverse client base, including global Pharma clients and small/mid-sized pharmaceutical and biotechnology firms. Expecto Health Science prides itself on providing cost-effective FSP solutions to meet the unique needs of its clients.

Role Description

• Efficiently manage and successfully execute all aspects of global start-up according to Sponsor specifications, including maintaining start-up timelines;
• Maintain ongoing Sponsor contact for submission issues by serving as primary contact for Sponsor and project team members;
• Independently interact with Sponsor, sites, Institutional Review Boards (IRBs)/Ethics Committees (ECs), regulatory agencies, and the Expecto team;
• Provide regulatory submissions advice and guidance to Expecto team to ensure compliance with appropriate regulations and requirements;
• Quality check of submission documents;
• Present during bid defenses, general capabilities meetings, and audits;
• Provide oversight of Regulatory Submissions Coordinators and Clinical Trial Assistants; and
• Review pertinent regulations and guidances to develop proactive solutions to regulatory issues and challenges.