Regulatory Affairs/Documentation Specialist (Entry)

2+ years

Not Disclosed

St. Louis

10 Jan. 18, 2025

Job Description

Job Type: Full Time Education: BA/BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Regulatory Affairs/Documentation Specialist (Entry)
Location: St. Louis, MO 63146
Employment Type: Contract
Job Category: Regulatory Affairs
Job Number: 616700
Is Job Remote?: No
Country: United States

Job Overview

The Regulatory Affairs/Documentation Specialist will support state regulatory activities related to crop protection products. This position involves working with state agencies on submissions, approvals, and renewals, and ensuring compliance with federal and state registration requirements.

Key Responsibilities

Support the team in managing state regulatory activities to obtain and maintain registrations, including FIFRA Sections 3, 24(c), 2(ee), 18, 5 for crop protection products.
Communicate with state regulatory agencies regarding submissions, approvals, renewals, etc.
Maintain and update regulatory databases and internal tracking systems.
Scan regulatory mail and documents, file electronically.
Track and process payment of state registration fees, including new product registration fees, annual state renewal fees, tonnage, etc.
Review product labels for accuracy and consistency.
Interpret and evaluate federal and state registration requirements to maintain compliance.
Provide regulatory support to both internal and external stakeholders.
Respond to inquiries for regulatory information from internal and external stakeholders.
File and manage regulatory and supporting documents.
Perform other assignments as required.

Required Qualifications

BA/BS in a field of science, business, or a related degree plus 2 years of professional working experience.
Strong attention to detail.
Highly developed written and oral communication skills.
Proficiency in Microsoft Office suite.
Experience in database management.
Strong problem-solving skills.
Ability to multitask and manage multiple projects.
Ability to work independently and as part of a team.
Experience with document comparison tools is a plus.

Additional Information

Planet Pharma is an equal opportunity employer committed to diversity, equity, and inclusion.

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Regulatory Affairs/Documentation Specialist (Entry)

Job Description

Job Overview

Key Responsibilities

Required Qualifications

Additional Information

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