Ria Aqmalia
Depok
Summary
Offering strong analytical and communication skills, with background in navigating complex regulations and government policies. Knowledgeable about stakeholder management, research, and data interpretation. Ready to use and develop critical thinking, problem-solving, and collaborative skills in Regulatory Affairs role.
Overview
8
8
years of professional experience
17
17
years of post-secondary education
1
1
Certification
Work history
Regulatory Affairs Associate
PT Johnson & Johnson
10.2020 - 01.2022
- Support Indonesia RA Consumer team undertaking a variety of regulatory operational and tasks under OTC product and Halal project activities
- Responsible for Halal Certification in Consumer Division (Drug, Medical device, and Cosmetic products)
- Coordinate with internal cross-functional team, internal manufacturer, and other related party to ensure compliance checks for any changes and variation which may be occurred for products and to ensure on-time approval
- Manage all regulatory system updated, assessed, and monitor regulation from Health Authority (BPOM & MoH) and Halal Bodies (LPPOM MUI & BPJPH) in weekly basis
- Responsible for E-report submission to MoH for Medical Device and Household products, and Cosmetic Report to BPOM
- Maintain good relationship with Health Authority & Halal Body
Senior Regulatory Affairs Associate
PT Pfizer Indonesia
03.2019 - 04.2019
- Preparing and reviewing the administrative and quality document based on BPOM requirement
- Monitoring the project timeline for document preparation and follow up activities related to document completion
- Responsible for local submission to BPOM (Drug product)
- Maintain good relationship with Health Authority
Dossier Development Specialist
PT Otto Pharmaceutical Industries
09.2015 - 02.2019
- Preparing and reviewing the quality document (Part III) in ACTD format of drug products and supplements
- Evaluating data/information which is received from related department (R&D, QA, QC, BD, RA, etc) to ensure its compliance with regulation before being submitted by RA team to NRA
- Monitoring the project timeline for dossier preparation and follow up activities related to document completion
- Completing the additional data or justification statement which is requested by NRA
- Responsible for local and export registration documents
Assistance of Formulation Scientist
PT Dexa Medica
09.2014 - 06.2015
- Responsible for formulation development, optimization, and process development of solid dosage form
- Performing scale-up activities and drafting the dossier and other documentation to supports product registration
- Write technical reports and others documents necessary for product submission to NRA in compliance with the regulatory requirements
Regulatory Affairs Officer
PT Dexa Medica
12.2013 - 09.2014
- Preparing administrative document in ACTD format
- Submitting drug product and medical device registration documents to NRA
- Ensuring approval from NRA will be achieved on time
- Maintaining a good relationship with related departments in site of manufacturing, R&D, Business Development, and NRA
Education
Pharmacy Professional Degree - Pharmacy
Bandung Institute of Technology
Bandung 01.2012 - 01.2013
Bachelor's degree -
Bandung Institute of Technology
Bandung 01.2008 - 01.2012
Senior High School -
SMA Negeri 3 Bandung
Bandung 01.2005 - 01.2008
Junior High School -
SMP Negeri 5 Bandung
Bandung 01.2002 - 01.2005
Elementary School -
SD YWKA III Bandung
Bandung 01.1996 - 01.2002
Skills
- Drug Regulatory affairs submissions
- Drug Regulatory strategies
- Indonesia Halal Certification (Drug, Medical Device, and Cosmetic)
- Medical device stock reporting to MoH
- Document Legalization for export-import purpose
Accomplishments
- 1st winner (in a group) 'Poster Exhibition APPS 9th in Seoul': International Event
- 2nd winner 'Lomba Essay Lingkungan Ganesha Hijau ITB': National Event
- Selected for Forum Indonesia Muda Rescue Team in Yogyakarta: National Event
- 1st winner 'Lomba Artikel Hari Kartini dan Hari Bumi' SMA Negeri 3 Bandung: Local Event
Personal Information
- Family Status: Married
- Date of birth: 07/31/90
Custom
- Writing
- Reading
- Hiking
Languages
English
Intermediate
Affiliations
- Hiking, Travelling
Certification
Indonesia Registration Certificate of Pharmacist (Valid until Lifetime)
Timeline
Regulatory Affairs Associate
PT Johnson & Johnson
10.2020 - 01.2022
Senior Regulatory Affairs Associate
PT Pfizer Indonesia
03.2019 - 04.2019
Dossier Development Specialist
PT Otto Pharmaceutical Industries
09.2015 - 02.2019
Assistance of Formulation Scientist
PT Dexa Medica
09.2014 - 06.2015
Regulatory Affairs Officer
PT Dexa Medica
12.2013 - 09.2014
Pharmacy Professional Degree - Pharmacy
Bandung Institute of Technology
01.2012 - 01.2013
Bachelor's degree -
Bandung Institute of Technology
01.2008 - 01.2012
Senior High School -
SMA Negeri 3 Bandung
01.2005 - 01.2008
Junior High School -
SMP Negeri 5 Bandung
01.2002 - 01.2005
Elementary School -
SD YWKA III Bandung
01.1996 - 01.2002
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