Job Responsibilities:
1. Prepare and compile registration dossiers (data, applications of certifications or others as indicated) for review and checked by superior.
2. To apply for Certificates of Pharmaceutical Product/Good Manufacturing
3. Practice/Indication from local Authority arrange for notarization, legalization and certification of documents by the Notary Public and Embassy of country as needed.
4. To perform preliminary review and check of Artwork materials generated for use in submissions (new product, variation, renewal) with reference to stipulated label requirements of the respective country of export and import.
5. To follow up ongoing task, registration projects proactively with effective communication (by team call, drafting letter, email with the respective project stakeholders.
6. To apply drug product registration renewal, variation as needed.
7. To apply and maintain Pharmaceutical Manufacturing License and Import License renewal of and update certificates- to Purchasing and Shipping Departments.
8. To keep track the validity GDPMD certification for Medical Device and update database Medcast as needed.
9. To track, highlight and update any significant (minor/major) developments of registration projects in the ongoing manner to the superior and to summarize progress in monthly regulatory reports, tracking logs, etc.
10. To liaise with local Authority related to regulatory affairs.
Any other project/assignment that will be advised / directed by the superior.
Requirements:
Possess a Bachelor Degree in Science
Administrative experience in legal/regulatory work functions.
Good skills in documentation and communication team spirit.
Job Type: Full-time
Salary: RM3,000.00 - RM4,500.00 per month
Schedule:
Monday to Friday
Supplemental pay types:
Yearly bonus
Ability to Commute:
Senai (Required)
Ability to Relocate:
Senai: Relocate before starting work (Required)
