Regulatory Affairs Specialist

MSD

Jakarta

Job Description

ROLES & RESPONSIBILITIES

New Product Launching
• Actively involved in new product registration and launching, review registration dossier, monitor & performing best approach to registration process, and to provide update to cross-functional team in new product launch plan in order to ensure alignment to company strategy.
• Prepare and compile registration dossier for New Drug Application based on company data file or standard in accordance to Indonesia local HA (BPOM) requirement including other components of the registration package and ensure that the dossier is of high quality and accuracy completed in a timely and efficient manner also keep follow up and monitor progress of registration filing to achieve approval within target timeframe.

Product Lifecycle Management
• Maintain registration number by on time renewal registration submission by preparing registration dossier in accordance to FDA requirement and follow up registration process to achieve approval... More Detail

Apply Now

Similar Jobs

Companies Hiring in East Jakarta, Jakarta

SabiKerja

Taldio

Antal International

Stanley Black & Decker, Inc.

MSD

Michael Page

KOMPAS GRAMEDIA

Migunani&Co

Wings Group Indonesia (Sayap Mas Utama)

HP

ZALORA SOUTH EAST ASIA PTE LTD

Rockwell Automation

Bersama Digital Data Centres (BDDC)

Synapsis

PT Wira Internasional Teknologi

PT Medifa Infoyasa Suryantara

SF Express Indonesia

HiPros Digital Agency

Super Indo

Rentokil