Diani Savitri Email & Phone Number

Jakarta

Manage Regulatory and Pharmacovigilance team

Jakarta

- Ensure company’s activities are conducted in accordance with regulations and guidelines established by Health Regulatory Authorities, as well as in accordance with company’s SOPs.- Develop strategy and implementation plan for promotional review process to ensure promotional materials comply with regulatory, legal, and scientific requirements.- Develop regulatory strategy and implementation plan for new products, variations, and renewals.- Develop and execute QA strategy to ensure… Show more - Ensure company’s activities are conducted in accordance with regulations and guidelines established by Health Regulatory Authorities, as well as in accordance with company’s SOPs.- Develop strategy and implementation plan for promotional review process to ensure promotional materials comply with regulatory, legal, and scientific requirements.- Develop regulatory strategy and implementation plan for new products, variations, and renewals.- Develop and execute QA strategy to ensure compliance with Regulatory Authorities. - Manage activities such as audits, Regulatory Authorities inspections, and product complain and recalls.- Ensure that Regulatory Affairs & QA policies and procedures are effectively implemented, reviewed, and updated to maintain regulatory & QA compliance.- Facilitate the interactions between company and Regulatory Authorities to expedite resolution of company issues.- Responsible for leadership and people management in Regulatory Affairs & QA Dept. Show less

Jakarta

- As the head of Regulatory Affairs for Darya Group (PT Darya-Varia, PT Medifarma Laboratories, and PT Pradja Pharin) with 10 subordinates.- Responsible in leading and managing a team to obtain approvals of local product submissions (registered at BPOM/Kementrian Kesehatan).- Responsible in leading and managing a team to obtain approvals of export product submissions (registered at other FDA offices/ FDA of Affiliate’s countries).- Responsible in managing a team to obtain… Show more - As the head of Regulatory Affairs for Darya Group (PT Darya-Varia, PT Medifarma Laboratories, and PT Pradja Pharin) with 10 subordinates.- Responsible in leading and managing a team to obtain approvals of local product submissions (registered at BPOM/Kementrian Kesehatan).- Responsible in leading and managing a team to obtain approvals of export product submissions (registered at other FDA offices/ FDA of Affiliate’s countries).- Responsible in managing a team to obtain production/industry license and GMP certificate for new manufacturing facilities.- Responsible in managing a team to obtain precursor import license, BA/BE study approval, SAS, and other licences.- Provide decision making necessary to ensure successful submissions and approvals.- Develop regulatory strategy and implementation plan for new products, variations, and renewals.- Negotiate effectively and build strong relationship with Health Regulatory Authorities in a professional manner.- Provide strategic advice to project teams and senior management regarding current and emerging regulatory requirements, to expedite regulatory approvals and to determine potential impacts on organizational processes.- Ensure regulatory compliance.- Head of halal certification project. Show less

Jakarta

- Lead a team that consists of 5 subordinates.- Ensure on time product registration submission & approval for Kalbe Group products that registered at BPOM & Kementrian Kesehatan (MoH). - Ensure on time registration approval of other licenses (advertisement approval, import license, GMP certificate, CPP, BA/BE Study approval, clinical study approval, etc).- Keep updated with regulatory trend & give information to other departments regarding the implication of new regulations.-… Show more - Lead a team that consists of 5 subordinates.- Ensure on time product registration submission & approval for Kalbe Group products that registered at BPOM & Kementrian Kesehatan (MoH). - Ensure on time registration approval of other licenses (advertisement approval, import license, GMP certificate, CPP, BA/BE Study approval, clinical study approval, etc).- Keep updated with regulatory trend & give information to other departments regarding the implication of new regulations.- Enhance networking with regulators (BPOM, MoH, and patent office).- Conduct patent search and patent analysis for first branded generics.- As PIC of continuous improvement program, ISO 9001/14001, and PDCA. Show less

Greater Jakarta Area, Indonesia

Lead a team that consists of 5 subordinates, to manage regulatory submission and approvals for following product categories: drugs, food supplements, cosmetics, traditional medicines, food, and medical devices.

Greater Jakarta Area, Indonesia

- Design formulation and manufacturing processes for assigned products.- Plan, design, conduct and report relevant experiments to meet project timelines.- Prepare formula master file.- Prepare technical documents for registration submission.

Apothecary Professional Program

Master Of Business Administration (M.B.A.), Business Administration And Management, General

Cumlaude

Bachelor’S Degree, Pharmacy

Education record