Regulatory Affairs Associate

1 week ago

Singapore Kemin Full time

Overview:

ABOUT KEMIN


Kemin Industries, Inc., is a global, trusted science-based company that discovers, invents, develops, manufactures and commercializes functional ingredients and feed additives for the health and nutrition industry.

Headquartered in Des Moines, Iowa, with a vision to "sustainably transform the quality of life every day for 80 percent of the world with our products and services" we are known for our scientific excellence, product innovations and our commitment to publishing important fundamental science findings, often paving the way in discovering and communicating important insights to our customers.

Kemin Industries, Inc., has annual worldwide sales of more than US$1 billion and manufacturing facilities in more than 10 countries.

Kemin Industries (Asia) Pte.

Ltd, with manufacturing and research facilities in Singapore, is the regional headquarters for Asia Pacific, covering Australia, New Zealand, Japan, Korea, Taiwan, Vietnam, Indonesia, Philippines, Thailand, Malaysia, Singapore, Brunei, Cambodia and Myanmar.

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 crossfunctional team including manufacturers, scientists, and marketing and sales colleagues
  • Offer advice about company's policies and practices eg. regulatory landscape, product registration processes, dossier 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' inquiries and resolve issues related to regulations and compliance matters.
  • Manage the Product Label System and Dossier Database Sharepoint.
  • Support the Regulatory Affairs Manager and R&D Director in various other activities as assigned.

Qualifications:

  • Degree in Science (Biochemistry/Chemistry/Microbiology/Food Science/ Biotechnology/Life Sciences) or equivalent from a reputable University.
  • At least 35 years of regulatory affairs experience
  • Experience in animal feed additive registration would be ideal
  • Ability to understand advanced scientific data and information to generate dossiers for regulatory submissions
  • Selfmotivated 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 fastpaced and multidisciplinary environment, with diverse group of people
  • Proactive team player with problemsolving mindset and excellent interpersonal skills
  • Proficient in Microsoft Office (Excel, Word, PowerPoint, etc.), with aptitude to learn new software and systems
  • Some basic experience in handling legal contract is preferred
  • Ability to follow up with parallel ongoing projects, with good time management.

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