Regulatory Affairs Executive - 1 Year contract

Mô tả Công việc

JOB PURPOSE

• To support feed device product registration activities and product registration submissions, promptly by regulatory and company requirements.
• Range of registration products:
• Import products: FAI, Bernaqua, and vet drugs
• Domestic products: Aqua products and livestock products (Hanam factory)

DUTIES:

• Support registration activities by compiling and maintaining appropriate registration dossiers.
• Gathering, evaluating, organizing, managing, and collating information in a variety of formats.
• Monitor and set timelines for license variations and renewal approvals
• Ensuring compliance with regulations set by the Department of Livestock Production, Directorate of Fisheries, and Department of Animal Health.
• Maintaining familiarity with company product ranges.
• Keeping up-to-date with changes in regulatory legislation and guidelines.
• Obtaining marketing permission.
• Specify storage, labeling, and packaging requirements.
• Using a variety of specialist computer applications.
• Liaise with, and make presentations to, regulatory authorities.
• Negotiate with regulatory authorities for marketing authorization, certificates, audits,
• Writing comprehensible, user-friendly, clear product information leaflets and labels.
• Ensuring that quality standards are met and submissions meet strict deadlines.
• Assist in preparation of domestic e-copies and other documentation for submission to government and other agencies as well as for submission to distributors.
• Maintain international approval history of products.
• Maintain regulatory files, databases, and chronologies.
• Carry out other similar tasks as assigned.

Yêu Cầu Công Việc

• Education: a bachelor's degree with a major in agriculture, veterinary medicine, or feed manufacturing.
• Language: English Communication
• Computing: Word, Excel, handling data skills.
• Experience: at least 3-5 years of experience in regulatory affairs or equivalent experience.
• Possess computer competency in Microsoft Office software, data collection, and general analysis tools