Executive/ Sr. Executive -Regulatory Affairs
Salary undisclosed
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- Prepare applications for the permits, licences, certificates, authorisations, and other approvals that the organisation needs to conduct its business activities; and produce, sell, and distribute its goods and services.
- These may include product licences, manufacturing, import and export permits. Prepare and coordinate registration and development of trademarks for the organisation's range of products.
- Document and maintain the product dossiers, certification applications and filings required to operate.
- Communicate regularly with federal regulators and ensure company policies strictly adhere to statutory requirements.
- Prepare management reports and rate filings and make recommendations for new rate schedules.
- Assist the area in relation to processes of product qualification and certification with government regulatory agencies.
- Degree in science or related field.
- More than 3 years experience as regulatory affairs in medical industries.
- Proficiency in both written and verbal English language.
- It will be an advantage if you experience regulatory affairs beyond Malaysia or from the pharmaceutical industry.
- It will be an advantage if you experience in Quality Management and GDPMD.