The Regulatory Reporting Coordinator ensures documentation fulfills all requirements and meets filing deadlines. Coordinates the tracking, preparation, and completion of regulatory filings, registrations, licensing, and compliance documents. Being a Regulatory Reporting Coordinator requires a bachelor's degree or equivalent. Assists with noncompliance investigations and implementing and monitoring compliance controls. In addition, Regulatory Reporting Coordinator typically reports to a supervisor or manager. Being a Regulatory Reporting Coordinator work is closely managed. Works on projects/matters of limited complexity in a support role. Working as a Regulatory Reporting Coordinator typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)
Essential Tasks and Responsibilities:
· Review raw material documentation and make disposition decisions
· Assist with training and oversee risk management activities ISO 14971, HACCP, etc.
· Assist with development and review of documents related to regulatory compliance
· Oversee quality auditing (including supplier quality) and assist with review and approval of Batch Production Records and NCMR investigations.
· Support regulatory and customer audits.
· Manage corrective actions as assigned from audits.
· Support and coordinate efforts and priorities with other departments to ensure timely release of the raw material, packaging components and finished products.
· Oversee creation and approval of necessary documentation for out-of-house processing.
· Complaint management including internal investigations.
· Continuous Improvement.
· Review product labels for content, appearance and regulatory compliance.
· Other responsibilities as assigned.
Education & Experience Requirements
· Scientific degree or equivalent strong analytical experience
· Knowledge and experience in good documentation practices
· Understanding of cGMP 21 CFR 111 and other regulatory requirements pertinent to dietary supplements, or pharmaceutical manufacturing and laboratory testing
· Strong preference to experience in TGA or MHRA
Competencies & Qualifications
· Attention to detail and accuracy
· Excellent interpersonal and listening skills
· Strong verbal and written communication skill
· Data analysis and problem solving
· Adaptability and initiative
· English proficiency required
Physical Requirements:
· Employee must exert up to 20 lbs. of force occasionally, and/or up to 10 lbs. of force frequently, and/or a negligible amount of force constantly to move objects
· Specific vision abilities required by this job include close vision, distant vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
· May be exposed to a dusty environment and/or considerable noise
Job Type: Full-time
Benefits:
Schedule:
Ability to Relocate:
Work Location: In person
0 Regulatory Compliance Coordinator jobs found in Logan, UT area