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. The Regulatory and Start Up Specialist will be responsible for preparing Clinical Trial Application Forms and submission dossiers for Competent Authorities and Ethics Committees.Responsibilities include:

• Preparing submission dossiers for regulatory bodies.
• Interacting with regulatory authorities and ethics committees.
• Providing regular updates to the Start Up Lead and Project Manager.
• Maintaining project plans and regulatory intelligence tools.
• Developing study-specific start-up plans.
• Customizing Patient Information Sheets and Informed Consent Forms.
• Coordinating document translations.
• Maintaining communication with key functions.
• Collecting and maintaining site-level critical path data.
• Supporting budget negotiations and investigator contracts.
• Keeping updated knowledge of local clinical trial laws.
• Maintaining audit/inspection readiness.
• Supporting pre-study site visits.

Requirements:

• Bachelor’s degree in life sciences or related field.
• 1+ years of experience as a Regulatory or SU specialist.
• Strong communication and organizational skills.
• Experience with computerized information systems.
• Fluency in English.

Precision for Medicine offers:

• Opportunity to contribute to groundbreaking cancer therapies.
• Appreciation for employee contributions.
• Valued and nurtured ideas.
• Remote work opportunity.