Experience

PT Actavis Indonesia

• Indonesia
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Senior Regulatory Affairs Specialist

  • Aug 2019 - Present

  Working as Senior Regulatory Affairs Specialist at PT Actavis Indonesia (Teva Group) Handle document requirements for registration and artwork (packaging) export products. Maintain registration in Asia Pacific and Europe market. Main project manage change of site product (Site Transfer and Technology Transfer) and manage packaging development for export products. Job description: Manage and review export product registration. Maintain New submission, renewal, and variation registration to all market/country authority. Manage all marketing authorization approval from each Authority. Coordination with all RA market/country as colleagues. Manage local registration (New submission and renewal) needed for all export products until LKE (Lokal Khusus Ekspor) received from BPOM as export license. Create CPP (Certificate of Pharmaceutical Product). Packaging development management, monitoring of changes, Registration, Approval, and implementation. Manage Change control and CAPA related to export registration, change management proposed by internal Actavis and all market. Create monthly report. Weekly meeting for Asia Pacific and Europe Market. Show less



PT Ethica Industri Farmasi

• Indonesia
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Regulatory Affairs Executive

  • Dec 2017 - Jun 2019

  Working as Regulatory Affairs Executive at PT Ethica Industri Farmasi joint venture with Fresenius Kabi. Handle new submission, Renewal, variation, and notification for all local and import products. Main project are Site Transfer and Technology Transfer registration. Job description as RA: Dossier reviewer, dossier preparation, submission, negociation until get Marketing Authorization Approval (NIE). Manage all registration process and procedure to BPOM as RA. Artwork (Packaging) review, circulate, and manage artwork approval from Authority. Create report for internal meeting. Bi-weekly meeting with all departments (Production unit and Marketing Unit). Show less



RSUD Al-Ihsan

• Baleendah- Bandung

• Internship

  • Mar 2017 - Mar 2017



PT. Kimia Farma Apotek

• Indonesia
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Internship

  • Feb 2017 - Feb 2017



PT. KIMIA FARMA, TBK

• Indonesia
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Internship

  • Jan 2017 - Jan 2017



Universitas Padjadjaran

• Indonesia
• Higher Education
• 700 & Above Employee

• Laboratory Assistant

  • Feb 2015 - Sep 2016