Job Description

HSO way of working

In fulfilling our roles, we are

· Accountable for our own capabilities and development.

· Focused on delivering results without excuses, and

· Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.

We are looking for people who

· See beyond self and are impact focused.

· Consider the needs, challenges, and objectives of every person they interact with

· Exhibit positive reinforcement to help others succeed.

Works closely with and have impact on: Cross-functional teams such as RA, QA, ME, R&D, CTM, etc.

Reports to: Sr. Manager, Regulatory Intelligence

Function: Global Regulatory Affairs

Role Overview

This position is responsible for executing the Regulatory Intelligence (RI) management process at HSO globally which involves the collection, analysis, and interpretation of regulatory information to provide HSO teams.

Duties and Responsibilities

· Execution of Regulatory Intelligence management process

· Maintain chosen regulatory knowledge management platform

· Provide support on key regulatory questions e.g., providing the right, up-to-date information i.e., guidelines/legislation, analysis, and conclusions on issues

· Build and maintain strong relationships with functional teams to share intelligence information and trends

· Perform surveillance of regulations, standards, guidelines, common specifications, and other applicable regulations

· Share intelligence related to people, events, and organizations within the HSO organization

· Undertake other tasks that Hoya may reasonably require as assigned by the supervisor

· Contribute to the promotion and effective implementation of changes to policy and procedure for the benefit of Hoya

Requirements

Experience

· Minimum 2 years of Regulatory Affairs and/or Quality experience in medical device/pharmaceutical industry

· Must have good understanding of regulatory environment

· Experience with regulatory intelligence program is plus

Skills/Accreditations

· Fluent in Thai (Written and Spoken) preferred

· Excellent interpersonal and communication skills

· Meticulous and detailed

· Written and oral, able to communicate with credibility and convey complex information to a variety of audiences

· Proficient at process mapping, flowcharting, database systems, Excel spreadsheet, and Microsoft Office

· Able to work independently with minimal supervision

Academic Qualifications

· University degree in Science, Engineering, Biotechnology, or equivalent relevant experience

Travel requirements

· Up to 10% in a year

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