Regulatory Affairs Associate - Registration Specialist

Kemin Industries; Des Moines (IA); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Competitive financial package

401k match program

Generous paid vacation and holidays

Fitness reimbursement

Job summary

Kemin Pet Food and Rendering in Des Moines, Iowa, is seeking an RA Associate - Registration Specialist to support regulatory compliance by preparing and submitting regulatory documents, amendments, supplements, and annual reports. You will maintain regulatory databases and trackers with accuracy and real-time updates, and may represent Regulatory Affairs on cross-functional teams as you gain experience.

We offer an engaged, global biotechnology environment with opportunities for growth, a strong

Qualifications

• Bachelor's degree in a science related field with 3-5 years of related experience.
• Extensive knowledge of MS Excel, Word, and PowerPoint.
• Experience with FDA Center of Veterinary Medicine registrations, reviews, and procedures.
• Fluency in English is required (additional language(s) is a plus).
• Familiarity with regulations in the region.
• 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.
• Travel up to 10%

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 these 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.
• Serve as a Kemin liaison to major regulatory agencies and involved in government agency inspections, including, but not limited to FDA, CFIA, USDA, OSHA, DOT, FAA, etc. as needed.

Skills

MS Excel

Word

PowerPoint

Education

Bachelor's degree in science

Job description

Kemin Pet Food and Rendering in Des Moines, Iowa, is seeking an RA Associate - Registration Specialist to support regulatory compliance by preparing and submitting regulatory documents, amendments, supplements, and annual reports. You will maintain regulatory databases and trackers with accuracy and real-time updates, and may represent Regulatory Affairs on cross-functional teams as you gain experience.

We offer an engaged, global biotechnology environment with opportunities for growth, a strong