Job description - Regulatory Affairs Officer
Alternative job titles
(Junior) Regulatory Affairs Executive (Junior) Regulatory Affairs Specialist
(Junior) Regulatory Affairs Associate
Description
Regulatory input is required at all levels of the pharmaceutical industry and the involvement of the Regulatory Affairs Officer. The main responsibility of the Regulatory Affairs Officer is to plan and execute all activities necessary for the registration of new products and line extension indications.
Qualifications
A candidate for the position of Regulatory Affairs Officer there often possesses a pharmacy degree however on-the-job training and learning by experience is commonly practiced. A candidate for the Regulatory Affairs Officer position may have a minimal amount of relevant experience. Professional use of the English language; both written and verbal.
Competencies
- Excellent verbal and written communication skills
- Careful planning to achieve accurate and timely results
- Work precisely according to procedures, rules and regulations
- Recognise recurring issues and analyse their causes in order to reach a solution
Tasks
- Manage and facilitate all registration related activities
- Complete forms and requests originating from government agencies
- Maintain contact with regulatory authorities and company headquarters
- Provide the Project teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning
- Implement QA systems and generate SOPs
- Deal with quality related questions and complaints
- Update licensing and collect information on registration instructions and regulations
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