JOB SUMMARY
- Execute regulatory activities for cosmetics, pharmaceuticals, and medical devices in compliance with regulatory and legislative requirements to support timely and smooth launching of activities for marketing plan and sales of products.
KEY ACCOUNTABILITIES
- Prepare all documentation requirements in an accurate manner for product registration to ensure the Company meets the stipulated regulatory and legislative requirements of Malaysia & Singapore for timely approval.
- Carry out administrative matters related to all product registration, licensing, compliance and queries to ensure they are in accordance with Ministry of Health regulations in Malaysia & Singapore.
- Submit post-approval variations for changes.
- Handle all queries from the Ministry of Health of Malaysia & Singapore to ensure the accuracy of information is maintained.
- Liaise with appointed distributors on the redressing activities to ensure compliance of products labelling requirements of Malaysia & Singapore.
- Handle pharmacovigilance adverse event reporting.
- License application and maintenance.
- Permit application and follow-up.
- Maintain and manage the regulatory files to ensure filing records are up-to-date and accurate.
- Submit Advertisement Application to Medicine Advertisements Board (MAB).
KNOWLEDGE, SKILLS & EXPERIENCE
Knowledge
- Degree in Science or equivalent
Skills
- Poison registration with relevant authorities.
- Drug license renewal.
Experience
- 1-2 years experience in a similar capacity would be preferred.
- Experience with pharmaceutical product registration would be beneficial.
- Experience dealing with National Pharmaceutical Regulatory Agency (NPRA) is beneficial.