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Indah Prihandini

Pharmacist Regulatory A Fast Learner A Lifelong-Learner

About me

Hello

I'mIndah

In 2014, I was graduated from Padjajaran University, Indonesia, with major in Apothecary profession/Pharmacist (Apt.). Before that, I've got my bachelor degree in State Islamic University Jakarta, with major in Pharmacy (S.Far).
Long time ago before my current profession as Regulatory (when I was in college), I took some jobs such as math teacher in a tutoring agency in South Tangerang and freelance researcher in some projects in BPPT (Badan Pengkajian dan Penerapan Teknologi), Serpong. I have been very interested to execute and administer all regulatory process related to Government (BPOM, MoH, etc) Regulation and all of its implementation and to ensure compliance to all regulations, since I had internship at BBPOM Bandung, West Java in 2013.

I have started career as Regulatory Affairs (Coordinator) in Jayanata Group, Jaya Fajar Lestari, PT.
I have worked for the multiple high-end cosmetic brands, such as Babor from Germany; Valmont, L'Elixir Des Glaciers, Il Profvmo, and YS-UZAC, from Switzerland; J.F. Lazartigue, Maria Galland Paris, SLA Paris, and House of Sillage, from France; and Panpuri from Thailand.

Currently, I have been working in Global Mandiri Group, located at Central Jakarta, Indonesia, as Regulatory Affairs Manager for Nature Republic, Peripera, Suiskin, and more coming famous cosmetic brands from South Korea. Besides cosmetic products, I am also responsible for food and beverage product, Yogurtland from USA.

These all things are my own great adventure! And I am always ready for more.






Experiences - Duties

Regulatory Process

2014 - Now

Arrange registration documents for all products to BPOM Indonesia, Collecting and reviewing product registration documents from principal, Ensure the product claim comply with BPOM regulation, such as no "over claims", Preparing product registration documents to be submitted to BPOM online and offline (manual) system, Follow up, and get the approval based on timeline, preparing submissions of license variations and renewals to strict deadlines, Negotiating with regulatory authorities to get faster approval for Marketing requirements, Discuss with Marketing about products launching and shipping order.
Updating database notification/registration product list, Processing the KIT products, Requesting, checking, and analyzing all of the supporting documents of the product claims. Distribute an updated information intime to related department for compliance the labelling requirement of products in the market.

Regulatory Operational

2014 - Now

Responsible for requesting new product launch registration documents and product samples, Requesting and maintaining legal documents such as CFS, GMP, LoA, etc; Preparing and compiling Product Information File (PIF), such as Formula, CoA, etc., based on regulation in Indonesia.
Update all regulation in Indonesia, if any new regulations. Reporting to BPOM about adverse reaction to cosmetics (MESKOS) every 6 months (if it exists or not).

Import Permit

2014 - Now

Arranging all documents to be submitted on E-BPOM, Ministry of Trade (INATRADE), Ministry of Agricultural, in order to get import permit. Arrange the shipment with forwarder and the shipper, and prepare all documents to be submitted to Customs (Bea Cukai). Verify that all documentation adheres to import policies, legal, and regulatory compliance.

PERSONAL ATTRIBUTES - SKILL SETS

Good Personal Qualities

Responsible, initiative, trustworthy, highly self-motivated, good analytical skill, attention to details, helpful, excellent ability to handle multiple task and priorities, commited, and able to work under-pressure and beyond the work hours when required.

Computer Literacy

Good skill in Microsoft office, internet, photoshop, computer programs.

Good Interpersonal Skill

Good manner, good communication, and friendly, able to work individually or in team with everyone, be a dedicated team player in a dynamic environment. Fluently in speaking, negotiating, and discussion with Government Officer and Principal.

15

BRANDS

11

PRINCIPALS

1500

ESTIMATED TOTAL
REGISTERED PRODUCTS

5

AMAZING YEARS

Certificates

Ikatan Apoteker Indonesia (IAI)

Surat Tanda Registrasi Apoteker

(STRA)

Ikatan Apoteker Indonesia (IAI)

Sertifikat Kompetensi Apoteker

will be written as soonest.

INDAH PRIHANDINI
+62 812 1993 6149
South Tangerang, Indonesia

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