Regulatory Affairs Executive - 1 Year contract

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.

- Assisted in the preparation of domestic e-copies and other documentation for submission to government and other agencies as well as distributors.

- Maintain international approval history of products.

- Maintain regulatory files, databases, and chronologies.

- Carry out other similar tasks as assigned.

- 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