What are the responsibilities and job description for the Regulatory Manager position at Somafina?
Essential Tasks and Responsibilities:
• Review raw material documentation and make disposition decisions.
• Oversee review of documents related to the raw material and finished product release to ensure quality and accuracy.
• Oversee quality review and approval of all Batch Production Records.
• 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.
• Review product labels for content, appearance and regulatory compliance.
• Other responsibilities as assigned Director of Quality Control. Education & Experience Requirements
• Scientific degree or equivalent • Knowledge and experience in good documentation practices
• Understanding of 21 CFR 111 and other regulatory requirements pertinent to dietary supplements, or pharmaceutical manufacturing 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.
