Regulatory Submissions

**Responsibility**: - Under the direction of senior staff, assist with the formatting and compilation of regulatory submissions through such tasks as entering information into Tables of Contents and creating tabs and submission labels. - Provide support assistance to senior staff in the upkeep of regulatory authority submission and correspondence logs (add...

**~Responsibilities**: Manages interface with Affiliate/Agency for key projects/issues Implements regulatory strategies for assigned projects for countries Represents the regulatory function at sub-teams or client group meetings to present regulatory requirements or provide strategic input for the registration of products. **Requirements**: Minimum 3...

We are seeking an experienced and highly organized Procurement & Submissions Manager to oversee and coordinate procurement processes while ensuring the smooth operation of the company's administrative functions.The ideal candidate will manage purchasing, supply chain logistics, and vendor relationships, while also providing strategic leadership in...

Roles & ResponsibilitiesWe are seeking an experienced and highly organized Procurement & Submissions Manager to oversee and coordinate procurement processes while ensuring the smooth operation of the company's administrative functions.The ideal candidate will manage purchasing, supply chain logistics, and vendor relationships, while also providing strategic...

Job Summary: We are currently seeking a full-time, office-based Study Start up Submissions Coordinator to join our Clinical Operations team in the Singapore office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your...

Roles & ResponsibilitiesJob 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 markets Craft and execute regulatory program strategies to ensure efficient submission planning and execution,...

**Position**: Vice President, Regulatory Affairs **Geographical Focus**: Southeast Asia and Taiwan, expanding to the MENA market **Key Responsibiliites**: - Craft and execute regulatory program strategies to ensure efficient submission planning and execution, with a keen focus on guiding projects from initial concept to market delivery. - Direct and...

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...

Job Title: Regulatory Affairs SpecialistJob Description:Assist the Regulatory Affairs Manager in regulatory activities for clinical trials and marketing authorisation.This includes submitting applications and variations across all pipelines, supporting regulatory assessments of submission requirements based on relevant regulations, assisting with...