Regulatory Submissions

Job Summary We are currently seeking a full-time Study Start Up Submissions Manager to join our Clinical Operations team in Singapore. Responsibilities Efficiently manage and successfully execute all aspects of global start-up; Perform quality checks on submission documents and site essential documents; Prepare and approve informed consent forms; Review...

**Company Description** Work with Us. Change the World.** At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the...

Company Description Work with Us. Change the World.At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the world's...

**Salary**: up to $5500 **Duration**: 1 year contractWorking Days & Hours: Mon-Fri Office HoursLocation: Tuas - Manage a portfolio of CTAs including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities such as substantial amendments, end of trial notifications etc. - Provide advice on submission...

**Job Description**: Including but not limited to: - Regulatory dossier review and submission - Liaison with internal and external regulatory stakeholders - Provide strategic input on regulatory strategirs to achieve acceleration Handles all regulatory aspects Job Requirement: - Experience in Singapore Regulatory Agency submission, Biologics submission -...

Location : WoodlandWorking Hours : 5 days per week (Mon to Fri: 8:00 AM – 5:30 PM)Willingness to commit to extended hours if requiredJob DescriptionPrepare and coordinate Development Control (DC) , Building Plan (BP) , and TOP/CSC submissions to BCA and URALiaise with QP (Architect) and consultants for regulatory approvals from SCDF, PUB, NEA, LTA, and...

Position Specialist, Regulatory Product Strategy & Delivery – Singapore (Regulatory Affairs)Overview Regulatory Affairs at ResMed is central to ensuring timely and compliant access to global markets. The Singapore RPSD team leads regulatory strategy and delivery for products where ResMed Singapore is the legal manufacturer, supporting New Product...

Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced Oversee documentation efforts to ensure compliance with local and international regulations and standards. Develop and maintain standard operating procedures. Develop regulatory strategies and implementation plans for the...

**Location**: Woodland - **Working Hours**: 5 days per week (Mon to Fri: 8:00 AM - 5:30 PM) - Willingness to commit to extended hours if required - Prepare and coordinate **Development Control (DC)**, **Building Plan (BP)**, and **TOP/CSC**submissions to BCA and URA - Liaise with QP (Architect) and consultants for regulatory approvals from SCDF, PUB, NEA,...

Job DescriptionLead the oversight of regulatory projects from inception to completion within the assigned portfolio, ensuring deep understanding and application of regulatory strategies in the Asia Pacific and future global marketsCraft and execute regulatory program strategies to ensure efficient submission planning and execution, with a keen focus on...