BE PART OF OUR TRANSFORMATION JOURNEY
Sandoz Indonesia, an establish multinational pharmaceutical company looking for dedicated and dynamic individual to join our team as :
Job Purpose:
- The registration variation of existing (approved) drug products in order to ensure products compliance.
- To deliver variation approval in order to ensure viability of these products in the marketplace.
- Make sure the Registration Dossier comply with the current requirement.
Major Accountabilities:
- Coordinate with related Department (i.e. Tech Ops / QA / BusDev / Marketing / Medical / SCM) regarding required documents for Registration Dossier.
- Reviewing received documents from RCC and/or Local Tech Ops/QA.
- To prepare the Registration Dossier in ACTD format (Local, Import, Export) for new submission, variation and export.
- To assure the quality/completeness of Dossier according to the updated requirements
- To submit the variation application to local authorities (BPOM / DepKes) according to the agreed timeline.
- To Monitor and Follow up the Application during the evaluation phase at local authorities (BPOM/Depkes) until the Approval for the changes obtained as per target.
- To Develop and maintain Good Working Relationship with related department and local authorities (BPOM/ DepKes)
- Provide up-to-date information to her/his superior regarding Drug Regulation
- Built a good team work in Regulatory Affairs Department to achieve Department objective.
- Continuously assess the working process to improve the work performance
- Support Change Control : Provide/submit variations to support post-submission/existing approved products/pre-launch changes
- To evaluate all change control coming from all Department (especially from Tech Ops)
- Update product information regarding safety issue based on Global CDS.
- Trademark maintenance in coordination with Global Trademark Sandoz.
Backgroud:
Education: Pharmacist
Experience:
- Minimum 2 years experience in regulatory field (registration of pharmaceutical products)
- Having good skill in ACTD Preparation
- Good Communication and Interpersonal Skill for handling BPOM
- Computer Literate (Ms. Office)
- Having Driving License (SIM A)
Please send your complete resume by using :
QUICK APPLY or NON-MEMBER APPLY
or
Mailing address:
PT. Sandoz Indonesia
Jl. TB. Simatupang, Kp. Gedong
Pasar Rebo, Jakarta 13670
Ensure the sales and marketing department has the integrated systems in place to reduce manual input and improve the information accuracy and availability.
Ability to assess and evaluate different systems to determine appropriate options for Sandoz.
Review and analysis current systems at the processing level to improve data integrity and quality output of system.
Work with IT department and third parties to integrate, improve and mange any projects related to department.
Proactive monitoring of technical directions and strategies of existing applications and tools.
Provide a training solution to users of systems to ensure associates can navigate their way around and use our systems to improve their effectiveness and efficiency.
Provide line management to subordinates.
Ensure mentoring and coaching to direct and non direct subordinates and peers to improve system usage, integrity and development.
Work with related departments to develop and improved systems which will benefit Sandoz eg SFE, Marketing Services etc
