We are looking for an experienced Regulatory Officer to manage key regulatory submission projects. The Regulatory Officer is responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements. The Regulatory Officer reports to the Head of Clinical Services.
Roles and Responsibilities:
* Manage the activities of Regulatory Affairs within the field of responsibility, including the preparation, co-ordination and following-up of the necessary documentations and/or supplements needed for regulatory agency submissions
* Serves as the main point of contact for the planned clinical studies needed for regulatory submissions (from implementation to closing)
* Assure project requirements are met; establishes and manages project timeline. May function as the project contact with third party vendors.
* Collect, collate, and evaluate scientific data from a range of sources
* Prepare submissions and renewals of regulatory documents to strict deadlines
* Liaise and manage external communications to the regulatory authorities
* Provide regulatory input for agency evaluations and due diligence activities
* Coordinate successful submissions and approval of all applications
* Other duties as assigned
* Degree in medicine, health care, life sciences or related fields. MSc/PhD would be an advantage
* Proven regulatory affairs working experience in Pharmaceutical, Biotechnology, Medical Device or CRO industry
* Therapeutic experience in NASH is an advantage
* Read, write and speak fluent English; excellent verbal and written communication skills
* Excellent internal communication skills
* Excellent analytical and management skills
* Solid organizational skills including attention to detail and the ability to multi-task and manage various project elements simultaneously
* Strong working knowledge of Microsoft Office
About Histoindex Pte Ltd
Involved in R&D, manufacturing and distribution of optical medical imaging equipment, as well as in the provision of related services to aid tissue assessment and evaluation of treatment efficacy for fibrosis and cancers. AI-based digital pathology systems function on Second Harmonic Generation (SHG) and Two-Photon Excitation (TPE), which can quantify important biomarkers like collagen fibers, and generate objective and highly accurate data for pathologists.