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.
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)
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.