Regulatory Affairs Associate

Overview

Our Food Technologies team is hiring a Regulatory Affairs Associate! In this role, this person will be responsible for preparing regulatory submissions such as amendments, supplements, and annual reports in accordance to local regulatory requirements. In addition, they will accurately populate and maintain the databases and trackers in real time. This person may also represent Regulatory Affairs on project teams, as more experience is acquired. This role will involve the use of M3 an ERP system that is used to manage product formulas and creation of labels and other regulatory collateral. 

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.    

We are 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.   

For over half a century, Kemin has been dedicated to using applied science to address industry challenges and offer product solutions to customers in more than 120 countries. Kemin provides ingredients to feed a growing population with its commitment to the quality, safety and efficacy of food, feed and health-related products to customers around the world.    

Established in 1961, Kemin is a privately held, family-owned-and-operated company with more than 2,800 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. 

As a Kemin team member, you’ll receive…  

• A competitive financial package- in addition to your salary, we offer an uncapped bonus opportunity, 401k match program, and paid vacation and holidays. 
• Robust health and wellness support- we are proud to offer a fitness reimbursement (for your whole family!), an on-site fitness center, restaurant with seasonal fresh food options (and the ability to order food to bring home), and free fresh fruit in break areas- to name a few.  
• Continued learning opportunities- Kemin offers tuition reimbursement and recently launched a new corporate university with online and in-person training opportunities for growth and development throughout your entire career.  
• The chance to give back to our world- Through our foundation of servant leadership, we are proud to offer ample service opportunities, including paid time off to do so. Kemin has a valued corporate partnership with both The World Food Programme and Habitat for Humanity, in addition to many local initiatives. 
• Opportunities to support our valued educators- Kemin is a proud sponsor of the Iowa Governor's Stem Advisory Council where we fund annual teacher's awards. In addition, we have a robust internship and externship program, and frequently host student tours. 

Responsibilities

• Prepare registration dossiers, amendments, monthly reports, and supplements for submissions to regulatory authorities with limited supervision.
• Review and recommend changes for departmental SOP's.
• Provide input to support the assessment for changes regarding all manufacturing/testing facilities for the market.
• Under limited supervision, may represent Regulatory Affairs on team projects, as they gain knowledge.
• Understand regulatory requirements and relevant government regulations in the region, as well as stay current on regulatory issues affecting Kemin products in applicable countries.
• Evaluate and research any submission deficiencies, additional information or testing as requested by regulatory authorities. 
• Follows and maintains an environment of food and feed safety in compliance with rules and regulations, as applicable.
• Other duties as assigned to support the IPRA team.

Qualifications

• Education and Experience:

  • Bachelor’s degree in a scientific background

  • 3 years related experience preferred.

  • Master’s Degree is a plus

• Extensive knowledge of MS Excel, Word, and PowerPoint software.

• Experience utalizing M3 ERP system is a plus 

• Fluency in English is required (additional language(s) is a plus).

• Familiarity with regulations in the region is a plus.

•  Excellent attention to detail required, reliable, highly motivated, ability to work independently and interacts well in a team environment.

•  Possess excellent verbal, written and interpersonal communication skills, demonstrated good technical writing skills, ability to present ideas effectively.

• Excellent organizational and time management skills, demonstrated prioritizing, planning and project management skills.

• Experience in reviewing and evaluating scientific literature with demonstrated ability to analyze and assemble/synthesize scientific information from many sources, including identification of information gaps and future research needs.

A post-offer background check and drug screen is required.  Additional pre-employment requirements may be necessary based on position.

Kemin is an equal opportunity employer, and all reasonable accommodations will be considered. Kemin is a drug-free and tobacco-free campus. 

#LI-KS1