Drug Regulatory Affairs Associate

Job description

  Job facts

Regulatory Affairs Associate is responsible for the registration of Roche products (including but not limited to New Drug Application (NDA), Line Extension and Variation) to the Indonesian Food and Drugs Authority (Badan Pengawas Obat dan Makanan Republik Indonesia (BPOM RI)) to ensure all of Roche products are approved in timely and professional manner and also responsible for regulatory compliance. Reporting to the Drug Regulatory Affairs Manager, you will be responsible for:

·  Prepare and complete the necessary documents (registration documents, Certificate of Pharmaceutical Product (CPP), Good Manufacturing Practice (GMP), Manufacturing License, etc.) for registration submission to local Head Authority in collaboration with Global Function (Pharma Development Regulatory (PDR), Pharma Technical Regulatory (PTR), International Product Partners (IPP)
·  Ensure regulatory compliance of Roche product registration process with BPOM regulation
·  Ensure that submission and follow up application to BPOM are performed in a timely and professional manner
·  Update the registration database and status (internal database, Global Product Regulatory System (GPRS)) in a regular basis
·  Support Marketing for tender documentation and supply chain for any queries related with registration approval status which will have impact to stock

·  Who we are

Roche Indonesia is located in the business district of Jakarta. We have 3 divisions: Roche Pharmaceuticals, Roche Diagnostics and Roche Diabetes Care; with more than 700 employees and keep growing. We've been in Indonesia since 1972 to answer the need for highly differentiated medicines and diagnostics for personalized healthcare. Our commitment is to continue providing accessible innovative treatments and solutions for every Indonesian patient; and to continuously “Doing now what patients need next”.

Roche is an equal opportunity employer.

Desired profile

Who you are

You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

You have a Pharmacy/Apothecary degree and graduate from reputable and accredited Pharmacy faculty locally or overseas. Furthermore you have the following skills and qualifications:

·  A thorough understanding of the drug registration processing at BPOM, preferably having > 2-3 years experience in similar position
·  Show excellent communication, inter-personal skills, and personal influence
·  Has effective time management skill and able to set priority in task planning
·  Demonstrate a self-driven person, autonomous, and able to accomodate pressures
·  Able to converse and write in English and computer literacy
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