Lowongan Product Information & Regulatory Affair Staff di PT Rohto Laboratories Indonesia

Responsibilities:

1. Collecting, preparing and submitting product registration dossier of Medical Device and Consumer Health Care Products (cosmetics and OTC drugs); including but not limited to : new application, renewal, variations.
2. Monitoring the status of each regulatory application and actively updating the status to the authority and take any appropriate action to keep the time line on schedule and make effort to accelerate the process if required by management.
3. Assessing packaging artwork from regulatory point of view as a part of new packaging development in order to make sure the packaging claim content is accordance with current regulation
4. Conduct a review of PIF (Product Information File) in accordance with the latest BPOM regulations and coordination with R&D, QA and Marketing for assessing the suitability of the product claims.

Requirements:

1. Bachelor degree in Pharmacy with minimum GPA 3.00, with Apothecary title from reputable university
2. Have minimum 1 years experience working in the same position, fresh graduates welcome to apply
3. Fluent in English and Tech savvy
4. Good analytical & critical thingking, Good problem solving, Fast learner, High adaptibility
5. Willing to be placed in Head Office - Jakarta