Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Additional Skills & Qualifications:
• High school diploma or equivalent required; Associate’s degree in a related field preferred.
• Previous experience in animal biologics, regulatory affairs, or business management is desirable.
• Excellent customer service skills with the ability to listen, analyze requests, and provide timely resolutions to customer issues.
• Effective verbal and written communication skills.
• Proficiency in organizing and tracking data and documents.
• Intermediate to advanced proficiency in Microsoft Office Suite and electronic document control systems.
Description:
Oversee the Document Change Control System under the guidance of the Regulatory Affairs Manager & offer general support to the Regulatory Affairs Department as required, assisting in applying regulatory requirements to ensure compliance with local, state, federal, and international authorities.
• Manages, tracks, and distributes correspondence with the USDA
• Supports dossier preparation tasks (e.g., photocopying, scanning, assembling binders)
• Assists in preparing Protocols and Reports (e.g., photocopying, scanning, compiling appendices)
• Aids in the preparation of International Registration documentation, including consularization and State Department Authentication
• Supports tasks related to Outlines of Production, Special Outlines, and Facilities Documents (e.g., photocopying, scanning, filing, distribution)
• Assists in revising controlled documents
• Facilitates Seed/Cell tracing activities (e.g., retrieving, scanning, uploading to an electronic archive system, filing)
• Provides support with document formatting as required
• Assists and trains users on the Document Control System
• Tracks the progress of documents through the change system
• Verifies resolution of all change-related issues prior to document approval
• Distributes all newly revised documents
• Collects and disposes of all outdated controlled copies
• Updates and distributes Master Standard Operating Procedures Indices quarterly
• Scans and uploads documents to an electronic archive system
Experience Level:
Entry Level
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