Caesaria Intilestari
Regulatory Manager
Jakarta Selatan
Summary
Regulatory affairs professional with strong expertise in ensuring compliance and navigating complex regulatory landscapes. Known for effective team collaboration and delivering results, adaptable to changing needs. Skilled in regulatory submissions, risk management, and policy development. Valued for strategic thinking, clear communication, and reliability.
Overview
15
15
years of professional experience
17
17
years of post-secondary education
2
2
Certifications
2
2
Languages
Work History
Regulatory Affairs Manager and Responsible Pharmacist
PT Nutrindo Interfarma Sejahtera
Jakarta, JK
01.2020 - Current
- Responsible for submitting and following up regulatory process for Human nutrition into the Authority
- Responsible for ensuring regulatory compliance with relevant regulations and effectively managing timely submissions to the appropriate regulatory authorities.
- Monitors regulatory agencies and industry changes, trends and requirements to contribute effectively to product development and regulatory strategies.
- Build close communication with Authority (Ministry of Agriculture, BPOM, Ministry of Health, and Ministry of Fishery and Marine)
- Contributes with regulatory support during health authority site inspections.
- Takes Participation in working and industry groups to provide input to shape the regulatory landscape and maintain prospective awareness of evolving regulatory expectations.
- Cooperates with other departments to collect information needed
- Responsible for halal management
Regulatory Affairs
PT BASF Indonesia
05.2017 - 12.2019
- Responsible for submitting and follow up regulatory process for Human Nutrition and Animal nutrition into the Authority
- Responsible for ensuring regulatory compliance with relevant regulations and effectively managing timely submissions to the appropriate regulatory authorities.
- Monitors regulatory agencies and industry changes, trends, and requirements to contribute effectively to product development and regulatory strategies.
- Build close communication with Authority (Ministry of Agriculture, BPOM, Ministry of Health, and Ministry of Fishery and Marine)
- Contributes with regulatory support during health authority site inspections.
- Takes Participation in working and industry groups to provide input to shape the regulatory landscape and maintain prospective awareness of evolving regulatory expectations.
- Cooperates with other departments to collect information needed
Regulatory Affairs Junior Manager and Responsible Pharmacist for PBF Raw material
PT Servier Indonesia
10.2016 - 05.2017
- Responsibility as Regulatory Affairs Junior Manager:
- Ensuring that company’s products comply with the regulations of BPOM
- Preparing submission document such as for new product, variations or renewal
- Monitoring and setting timeline for product from the pre-registration step until launching.
- Evaluating scientific data that want to submit to BPOM
- Follow up the process at BPOM
- Handling packaging management in company, to make it harmonize with country specific
- Handling report for pharmacovigilance
- Etc.
- Responsibility as Responsible Pharmacist for PBF raw material:
- To sign all the quarterly reports with regard to importation of pharmaceutical raw material that should be sent to BPOM;
- To ensure that the Warehouse and Laboratory is fulfilled with the minimum requisition set by BPOM and always in ready condition for inspection by BPOM;
- To assist the Director in preparing all matters related with the renewal or extension of PBF Raw Material License.
Regulatory Affairs Officer
PT Servier Indonesia
11.2011 - 09.2016
- Responsibility:
- Preparing submission document such as for new product, variations or renewal
- Evaluating scientific data that want to submit to BPOM
- Follow up the process at BPOM
- Handling packaging management in company, to make it harmonize with country specific
- Handling report for pharmacovigilance
- Etc.
Regulatory Affairs Officer
PT Tunggal Idaman Abdi
07.2010 - 11.2011
- Responsibility:
- Do close communication with Authority (BPOM)
- Do document submission and follow up the process
- Close communication with other department to get dossier or documents.
Education
SDN Jatikramat I Bekasi
01.1992 - 01.1998
undefined
MTs PPMI Assalaam Surakarta
01.1998 - 01.2001
undefined
SMU PPMI Assalaam Surakarta
01.2001 - 01.2004
Bachelor of Pharmacy - Pharmacy
Pancasila University Jakarta
Jakarta, Indonesia 04.2004 - 01.2008
Apothecary programme - Pharmacy
Pancasila University Jakarta
Jakarta 01.2009 - 01.2010
Skills
- Regulatory compliance expertise
- Good competencies as a responsible pharmacist
- Computer Literate (MS Word, MS Excel, MS Power Point, MS Outlook)
- Halal supervisor in the company
Certification
Certificate of Competence as Halal Supervisor
Timeline
Certificate of Competence as Halal Supervisor
10-2024
Pharmacist license
04-2021
Regulatory Affairs Manager and Responsible Pharmacist
PT Nutrindo Interfarma Sejahtera
01.2020 - Current
Regulatory Affairs
PT BASF Indonesia
05.2017 - 12.2019
Regulatory Affairs Junior Manager and Responsible Pharmacist for PBF Raw material
PT Servier Indonesia
10.2016 - 05.2017
Regulatory Affairs Officer
PT Servier Indonesia
11.2011 - 09.2016
Regulatory Affairs Officer
PT Tunggal Idaman Abdi
07.2010 - 11.2011
Apothecary programme - Pharmacy
Pancasila University Jakarta
01.2009 - 01.2010
Bachelor of Pharmacy - Pharmacy
Pancasila University Jakarta
04.2004 - 01.2008
undefined
SMU PPMI Assalaam Surakarta
01.2001 - 01.2004
undefined
MTs PPMI Assalaam Surakarta
01.1998 - 01.2001
SDN Jatikramat I Bekasi
01.1992 - 01.1998
Similar Profiles
Ricko Ricko null
Sales Supervisor at PT. Gemilang Mitra SejahteraSales Supervisor at PT. Gemilang Mitra Sejahtera
Teddy AriantoTeddy Arianto
Assistant Procurement Manager at PT. Dharmalancar SejahteraAssistant Procurement Manager at PT. Dharmalancar Sejahtera
Andra SaadAndra Saad
Marketing Manager at PT. Aditya Mandiri SejahteraMarketing Manager at PT. Aditya Mandiri Sejahtera
Hasinah JusufHasinah Jusuf
Legal and Compliance Director, Country Chief L&C at PT Asuransi Allianz Life IndonesiaLegal and Compliance Director, Country Chief L&C at PT Asuransi Allianz Life Indonesia