Regulatory & Documentation Specialist

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Regular Full-Time Oak Brook, IL, US

2 days ago Requisition

Salary Range: $80,000.00 To $86,000.00 Annually

Job Posting:
Regulatory & Documentation Specialist

Location
:
Oak Brook, IL

About the Role:

The Regulatory & Documentation Specialist is responsible for performing duties associated with regulatory affairs and compliance requirements relevant to the OTC pharmaceutical industry and Blistex Inc. Using knowledge of FDA and other regulations, the Specialist ensures that all documentation is in adherence with compliance standards for all Blistex Inc. products.

Key Job Responsibilities

• Administers and maintains the Company’s Change Control System for compliance documentation.
• Reviews and evaluates product labeling to ensure compliance with all regulations and requirements.
• Uses Food and Drug Administration (FDA) monographs and other regulations to develop compliant Drug Facts Box information including active ingredients and concentrations, uses, warnings, directions, and inactive ingredients.
• Uses guidance from international third-parties to develop country-specific formula ingredient lists.
• Monitors regulatory activities (via searches of government internet web sites, review of USP supplements, Federal Register publications, and other government communication vehicles) and proactively presents, advises, and executes internal programs associated with these activities.
• Maintains facility licenses and drug listings.
• Administers the adherence to procedural requirements in the development of Master Records.
• Reviews and approves specifications (labeling, raw materials, packaging, product certificates of analysis, etc.).
• Prepares dossiers and supports the registration of Canadian and other international products.
• Acts as the principal department contact for handling, planning, and responding to regulatory questions and requests.
• Develops and implements creative regulatory strategies, approval schedules, and submission standards to achieve department and organization objectives.
• Interfaces with Canadian and other international third-parties to ensure Blistex regulatory compliance.
• Interfaces with R&D staff and provides support in the compilation and submission of records for new product launches.
• Participates in facility audits and on issue-specific committees, as required by the Manager, Regulatory Affairs.
• Performs and assumes other duties and responsibilities, as may be required by the Manager, Regulatory Affairs.

Basic Qualifications

• Bachelor's degree in Chemistry, Biology, or related scientific discipline with 3-5 years of applicable Quality Assurance environment experience, preferably in the cosmetics/pharmaceutical OTC industry or 1-2 years of applicable Regulatory Affairs experience in the cosmetics/pharmaceutical OTC industry.
• Master's degree in Regulatory/Quality, or related scientific discipline with 1-3 years of applicable Quality Assurance environment experience, preferably in the cosmetics/pharmaceutical OTC industry or 1-2 years of applicable Regulatory Affairs experience in the cosmetics/pharmaceutical OTC industry.
• Demonstrates high standards of ethics and compliance. Creates culture of mutual trust and understanding.
• Attention to detail and ability to work well under pressure.
• Effective interpersonal skills to interact with various levels of internal and external customers.
• Proficient at effective communication skills (both written and oral) for interactions with Quality colleagues, project managers, and colleagues from numerous functional areas.
• Good oral and written communication skills in business English (spelling, grammar, and punctuation).
• Computer literacy in a Windows environment (Word, Excel, and Outlook).
• Ability to prepare detailed and accurate documentation.
• Able to present complicated compliance issues in a variety of business settings.
• Familiarity with FDA regulations and monograph system as they relate to OTC drug products.
• Working knowledge of Current Good Manufacturing Practices (cGMP).
• Strong organizational and analytical abilities.

Additional Qualifications

• Ability to work independently and meet deadlines on a multitude of concurrent tasks.
• Discretion with confidential information.
• Proficient at listening actively and readily assumes responsibility for actions and leads by example.
• Proficient at managing tactical steps to push tasks…