Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic
Caesaria Intilestari

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

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MTs PPMI Assalaam Surakarta
01.1998 - 01.2001

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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

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SMU PPMI Assalaam Surakarta
01.2001 - 01.2004

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MTs PPMI Assalaam Surakarta
01.1998 - 01.2001

SDN Jatikramat I Bekasi
01.1992 - 01.1998

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Caesaria IntilestariRegulatory Manager