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Annisa Firda Sukmana

@annisafirdasukmana

Regulatory Officer at PT Opella Healthcare Indonesia coordinating 40+ annual regulatory submissions for healthcare products.

Indonesia

Message

At PT Opella Healthcare Indonesia, I manage regulatory compliance for the existing CHC portfolio and coordinate regulatory submissions to support timely product approvals. I also assess regulatory risks and provide classification guidance for product concepts.

At Sanofi CHC Indonesia, I managed the JAYA Project and completed registration activities for 24 products within four months. My experience also includes regulatory dossier preparation, BPOM systems, and pharmaceutical analytical compliance.

Experience

Work history, roles, and key accomplishments

Current

Regulatory Officer

Current

PT Opella Healthcare Indonesia

Jan 2024 - Present (2 years 9 months)

Manage regulatory compliance for the existing CHC portfolio, including 20+ monthly marketing authorization and maintenance activities. Prepare and coordinate 40+ regulatory submissions annually, ensuring submission quality and compliance with agreed timelines.

Regulatory Compliance Regulatory Submissions Marketing Authorization Cross functional Coordination Regulatory Risk Assessment Veeva

Regulatory Trainee

Sanofi CHC Indonesia

May 2023 - Dec 2023 (7 months)

Monitored monthly BPOM regulatory updates and health authority guidelines to identify compliance requirements. Managed the JAYA Project and completed registration activities for 24 products within 4 months.

BPOM Regulations Regulatory IT Systems New Aero ASROT Notifkos SIAPik SIREKA Cross functional Coordination File Tracking

Pharmacist Intern

RSUD Prof. Dr. Margono Soekarjo

Oct 2022 - Dec 2022 (2 months)

Compounded and dispensed 20+ prescriptions daily for inpatient, outpatient, and emergency patients. Monitored medication use for 10+ pediatric inpatients weekly and managed pharmacy logistics documentation.

Pharmaceutical Compounding Dispensing Medication Monitoring Pharmaceutical Logistics Documentation

Analytical Compliance Intern

PT Dankos Farma

Aug 2022 - Sep 2022 (1 month)

Managed 20+ R&D quality assurance documents monthly, including SOPs and analytical compliance records. Reviewed analytical methods against updated regulatory requirements to support product renewals.

Quality Assurance Analytical Methods Regulatory Compliance Stability Testing Documentation

Pharmacist Intern

PT Anugerah Pharmindo Lestari

Apr 2022 - Apr 2022 (0 months)

Completed CDOB training to strengthen understanding of pharmaceutical distribution standards. Developed an optimization concept for the eZRx application to improve workflow efficiency.

CDOB Pharmaceutical Distribution EZRx Workflow Optimization