Regulatory and Start Up Specialist

Job Description

Precision for Medicine is seeking a Regulatory and Start Up Specialist to join their team in Singapore. This role is crucial for ensuring the timely and quality delivery of site activation readiness within assigned countries and sites, while also mitigating potential risks.Responsibilities:

• Preparing Clinical Trial Application Forms and submission dossiers for Competent Authorities and Ethics Committees.
• Interacting with CA/EC for study purposes and handling responses.
• Providing regular updates about CA and EC submissions to the Start Up Lead and Project Manager.
• Maintaining project plans, trackers, and regulatory intelligence tools.
• Supporting the development of study-specific start-up plans and essential document review criteria.
• Partnering with site CRAs to ensure alignment in communication and secure site review.
• Customizing country/site-specific Patient Information Sheets and Informed Consent Forms.
• Coordinating translations for documents.
• Maintaining communication with key functions such as Feasibility, Clinical Operations, and Site Contracts management.
• Acting as SME for site-level critical path data points.
• Supporting the negotiation of study budgets and the execution of investigator contracts.
• Keeping updated knowledge of local clinical trial laws and regulations.
• Maintaining audit/inspection readiness and filing documents as per TMF plan.
• Supporting the clinical team performing Pre-Study Site Visits.

Requirements:

• Bachelor’s degree in life sciences or related field, or Registered Nurse (RN).
• 1+ years of experience as a Regulatory or SU specialist in a CRO or pharmaceutical/biotech industry.
• Strong communication and organizational skills.
• Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail.
• Fluency in English.

The role offers:

• Opportunity to work remotely.
• Chance to contribute to a growing organization researching ground-breaking cancer therapies.
• A supportive environment where employee contributions are valued.