Regulatory Affairs Associate - Vietnam, Kemin Biologics

Overview

We Are Kemin

We are visionaries who see things differently and are inspired by the world around us. We have been dedicated to using applied science to improve the quality of life for over half a century. Committed to feed and food safety, Kemin maintains top-of-the-line manufacturing facilities where over 500 specialty ingredients are made for humans and animals in the global feed and food industries, as well as the health, nutrition, and textile markets. We provide product solutions and options to customers in more than 120 countries.

 

A privately held, family-owned and operated company, Kemin has more than 3,000 global employees including manufacturing facilities in Belgium, Brazil, China, India, Italy, Russia, Singapore, South Africa and the United States.

 

 

 

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Responsibilities

• Responsible for all veterinary vaccines/biological product regulatory clearance & registration processes, including compilation of dossiers and ensuring accuracy and completeness of the same. Be accountable for progress & deadlines for assigned countries
• Set up good regulatory network by establishing relationships with regulatory bodies in assigned countries
• Stay vigilant and keep abreast of the regulatory changes (veterinary vaccines/biological product regulations)
• Report on RA strategic plan monthly to RA Manager, participate in Kemin Biologics’ team tele-conference. Contribute to Kemin Worldwide RA network to ensure alignment of good practices and facilitate cross learning and sharing of information and resources.
• Ensure regulatory compliance for all products and take preemptive actions to uphold the integrity and image of the company and its products. Supervise the generation and maintenance of product documentation such as specification sheets, Safety Data Sheets, product labeling, etc. and product mock-ups.
• QA: assist in importation/batch release and GDP locally
• PhV: implement the future PhV system in the responsible countries
• Intellectual Property Management
  • Adapt & implement WWIPRA’s policies in the assigned countries.
  • Maintain & protect company confidential information (e.g. product formulas in the ERP system).
• Participate in company driven projects.

Qualifications

• Bachelor of Science or above, preferably in veterinary medicine, chemistry, or life science (e.g. agricultural science, food science, nutrition and etc.).
• Minimum 4 years of experience in regulatory affairs of veterinary biological products.
• Proven track record of accomplishments in getting veterinary biological product marketing authorizations in responsible countries.
• Knowledge & skills in intellectual property management.
• Possess good business acumen and customer orientated attitude, working experience in a commercial setting is an advantage.
• Pleasant personality, good people skills. Good team spirit and team management skills.
• Good project management skills.
• Creative & resourceful in handling various regulatory barriers.
• Communication skills - Ability to present ideas & suggestion effectively and communicate well with all levels of management in a multi-cultural environment.