Job Description

Overview

#LI-KT1

Responsibilities

• Manage and execute regulatory projects for product registrations in APAC countries, including dossier preparation and submission, authority liaison, and approval negotiation.
• Ensure timely renewal of existing product licenses in accordance with local regulations and guidelines.
• Monitor and communicate regulatory changes and updates in APAC countries and share the information within the organization.
• Interpret and provide regulatory guidance to cross-functional team including manufacturers, scientists, and marketing and sales colleagues
• Offer advice about company\xe2\x80\x99s policies and practices eg. regulatory landscape, product registration processes and requirements and intellectual property matters.
• Review materials such as marketing documents, technical collaterals to ensure accuracy, as well as compliance with policies and regulations in the APAC countries.
• Address customers\xe2\x80\x99 inquiries and resolve issues related to regulations and compliance matters.
• Manage the Product Label System and Dossier Database Sharepoint.
• Support the Regulatory Affairs functional Head in various other activities as assigned

• Degree in Science (Biochemistry/Chemistry/Microbiology/Food Science/ Biotechnology/Life Sciences) or equivalent from a reputable University
• 5 years of regulatory affairs experience
• Animal feed additive registration experience would be ideal
• Ability to understand advanced scientific data and information to generate dossiers for regulatory submission
• Self-motivated and meticulous with good organizational and negotiation skills
• Must have high level of integrity to handle confidential business information
• Good writing and communication skills
• Must be able to work independently in a fast-paced and multi-disciplinary environment, with diverse group of people
• Pro-active team player with problem-solving mindset and excellent interpersonal skills
• Proficient in Microsoft Office (Excel, Word, OneNote, PowerPoint, etc.), with aptitude to learn new software and systems
• Experience in legal contract management is preferred
• Ability to multi-task to follow up with parallel on-going projects and good time management of various tasks assigned

Kemin Industries