Key Responsibilities:
Product Registration
Acts as Liaison Officer in behalf of Kalbe International relating to product registrations and related matters; as such responsible for the following:
- 1. Regulatory matters concerning License to Operate from Distributor, Product Registration/Notification, Compilation/Consolidation of equivalent documents and requirements, and other regulatory matters.
- 2. Facilitate the application processes in all embedded regulatory agencies.
- 3. Defend/Comply with any findings/abeyance for the applied licenses, registration, permits and the like.
- 4. Expedite facilitation of all pertinent applications at time table target
- 5. Assist/train and update company personnel in regulatory/documentation requirements as required by the FDA
- 6. Prepare progress report to the Country Manager and Head Quarter.
- 7. Handle any other regulatory functions as may be needed
- 8. Ensure validity of CPR
Pharmacovigilance
As Pharmacovigilance Officer, responsible to carry out the pharmacovigilance SOP of KI
Documentation
Monitoring and updating of distributor LTO, S-licenses of principals and CPR.
- Monitoring reports containing records of products with Batch Notification and Lot Release Certificate
Coordinates with the concerned departments for the collection of data/information and preparation of the following reports. Monitors and maintains an up-to-date records of the same:
- Corrective action Requests/ CAPA Reports
- Customer Complaints
- Change Control Records
- Records of Principal and Third Party Audits
- Device Master Records (Medical Device)
Batch Certificates – Assists in monitoring batch certificates of received products; encodes BC in the system, otherwise coordinates with Regulatory Affairs Supervisor to suspend products for sale. In the absence of the RAS, acts as back-up in the suspension of the products in the system
Qualification
- Must be a license Pharmacist.
- Having experience in registration of pharmaceutical product. (at least 3-5 years).
- Having experience in registration of food (at least 3-5 years).
- Knowledge on registration.
- Carefulness, meticulosity, honesty.
- Problem solving.
- Good communication.
- Ability to work in both of independence and teamwork.
- Computer skill (Office software (Word, Excel, Power Point, Adobe Acrobat), graphic software (Adobe Illustrator, Corel))
- Willing to be assigned in Yakal, Makati City.
Job Type: Full-time
Benefits:
- Company Christmas gift
- Employee discount
- Health insurance
- Life insurance
- Opportunities for promotion
- Paid training
- Pay raise
Schedule:
- 8 hour shift
- Monday to Friday
Supplemental Pay:
- 13th month salary
- Performance bonus