Regulatory Affairs Associate - Vietnam, Kemin Biologics

Posted 2 Days Ago
Be an Early Applicant
Hồ Chí Minh, VNM
In-Office
Mid level
Biotech
The Role
Manages regulatory clearance and registration for veterinary vaccines and biological products in assigned countries. Responsibilities include dossier preparation, regulatory authority relationships, monitoring regulatory changes, compliance documentation, importation and batch release support, GDP, pharmacovigilance implementation, intellectual property management, and cross-functional projects. The role also tracks regulatory strategies, deadlines, product documentation, labeling, and mock-ups while contributing to global regulatory alignment.
Summary Generated by Built In
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.




#LI-KT1

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.

Skills Required

  • Bachelor of Science degree or higher, preferably in veterinary medicine, chemistry, or a life science such as agricultural science, food science, or nutrition.
  • Minimum four years of regulatory affairs experience with veterinary biological products.
  • Proven success obtaining marketing authorizations for veterinary biological products in assigned countries.
  • Knowledge and skills in intellectual property management.
  • Business acumen and a customer-oriented attitude.
  • Good interpersonal, teamwork, and team management skills.
  • Good project management skills.
  • Creativity and resourcefulness in handling regulatory barriers.
  • Strong communication and presentation skills in a multicultural environment.
  • Commercial-setting work experience.
Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Des Moines, IA
2,000 Employees
Year Founded: 1961

What We Do

Kemin Industries is a global ingredient manufacturer that strives to sustainably transform the quality of life every day for 80 percent of the world with its products and services. The company supplies over 500 specialty ingredients for human health, food safety and protection of the global food supply chain. Kemin ingredients offer solutions across various industries including animal health, nutraceuticals, pet food, food technologies, crop technologies, textiles, aquaculture and animal vaccines. Serving customers in more than 120 countries, Kemin works each day to provide ingredients that feed a growing population and is committed to the quality, safety and efficacy of food, feed and health-related products. Established in 1961, Kemin is a privately held, family-owned-and-operated company with more than 3,000 global employees and operations in 90 countries, including manufacturing facilities in Belgium, Brazil, China, India, Italy, Russia, San Marino, Singapore, South Africa and the United States.

Similar Jobs

Mondelēz International Logo Mondelēz International

Regional Sales Capability Manager, South

Big Data • Food • Hardware • Machine Learning • Retail • Automation • Manufacturing
Hybrid
Hồ Chí Minh, VNM
90000 Employees

SharkNinja Logo SharkNinja

Operations Excellence Senior Manager

Beauty • Robotics • Design • Appliances • Manufacturing
In-Office
Hồ Chí Minh, VNM
4000 Employees

UL Solutions Logo UL Solutions

Laboratory Engineer, Packaging Test

Automotive • Professional Services • Software • Consulting • Energy • Chemical • Renewable Energy
Hybrid
Hồ Chí Minh, VNM
15000 Employees

UL Solutions Logo UL Solutions

Intern, Chemical Safety Testing

Automotive • Professional Services • Software • Consulting • Energy • Chemical • Renewable Energy
Remote or Hybrid
Việt Nam
15000 Employees

Similar Companies Hiring

Formation Bio Thumbnail
Artificial Intelligence • Big Data • Healthtech • Biotech • Pharmaceutical
New York, NY
150 Employees
SOPHiA GENETICS Thumbnail
Software • Healthtech • Biotech • Big Data • Artificial Intelligence
Boston, MA
450 Employees
Pfizer Thumbnail
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
New York, NY
121990 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account