Industries
Consumer Products
Life Sciences

Practices
Regulatory Affairs

Location
Indonesia

Languages
Bahasa Indonesia
English

Education
BPharm, University of Indonesia
Hilda Nur Aziza
+6221 2971 8802

Biography

Hilda Nur Aziza is a regulatory affairs consultant in Tilleke & Gibbins’ Jakarta office, with particular expertise in advising clients on Indonesia’s requirements surrounding a range of life sciences products, including pharmaceuticals, cosmetics, and household health products. A licensed pharmacist in Indonesia, Hilda offers clients deep practical knowledge and understanding of the country’s regulations and its market for life sciences goods and services. In addition, she can assist clients with obtaining SNI (Indonesia’s national standards criteria) certification for toys and other goods, and SDPPI (Indonesia’s Directorate General of Resources and Equipment of Post and Information Technology) approval for Bluetooth and other technology products. In her wide-ranging regulatory affairs work, she prepares regulatory submissions and product registration applications for the approval of various government authorities, such as the BPOM (the National Agency of Drug and Food Control), the Ministry of Health, and so on.

Hilda graduated with a bachelor of pharmacy degree and obtained her pharmacist license from the University of Indonesia. Prior to joining the regulatory affairs team at Tilleke & Gibbins, she worked in regulatory affairs in the pharmaceutical industry and for a retail company in Indonesia.


Experience
  • Regularly advises clients on regulatory requirements for pharmaceutical products, cosmetics, food, and other goods and services.
  • Routinely prepares regulatory submissions, product registration applications, and product license maintenance requests by assessing and preparing dossiers for submission to the relevant authority, often involving frequent liaison with officers from the respective government office.
  • Advised a client regarding halal certification for cosmetic products to be offered for sale in Indonesia.
  • Provided advice to a client regarding advertising-related rules and regulations pertaining to medical devices in the Indonesian market.