JakartaKerja > Jakarta Pusat > Lowongan Executive Regulatory Affair di PT. Kharisma Potensia Indonesia

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PT. Kharisma Potensia Indonesiamembuka lowonganExecutive Regulatory Affair

PT Kharisma Potensia Indonesia adalah perusahaan yang bergerak dalam bidang support SDM.

Ringkasan

Pendidikan :
D1 - D3, S1 / D4
Gender :
Pria/Wanita
Umur :
Maks. 30 Tahun
Besaran Gaji :
6 - 7,5 Juta
Batas Lamaran :
31 Januari 2020
Lokasi Kerja :
Jl. Letjend Suprapto, Ruko Mega Grosir Cempaka Mas Blok K No 27, Jakarta Pusat, DKI Jakarta

Responsible for all activities associated with regulatory clearance for all products in the country
Where applicable, act as the main focal point for distributors pertaining to regulatory activities
Updates and maintain In-Country Registration Submission Tracker and Planner and other local requirements as deemed appropriate
Responsible to review and provide impact assessments for any changes to products. (e.g. change in packaging and labeling)
Responsible for providing regulatory input and review for new product development projects, promotional materials, local country specific labeling if needed
Undertake additional projects and tasks as assigned by the supervising manager
Provide regulatory inputs for and participate in GDP audits where appropriate
Build a good relationship with in-country junior regulators at the least (where appropriate)

Male/Female, maximum 30 years
Minimum Bachelor Degree in Science/Biomedical or equivalent
Minimum 2 years of working experience in a function related to regulatory or quality, preferably in the healthcare industry
Knowledge of quality systems or regulatory requirements preferably related to medical device
Must be fluent in English
Proficient in Microsoft Office (Word, Power Point, Excel)
Have good problem-solving acumen
Good team player
Independent, meticulous and communicates well
Placement at South Jakarta, salary negotiable