PT KHARISMA POTENSIA INDONESIA open recruitment : Executive Regulatory Affair
Requirement :
-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
Responsibiily :
-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)
Send your resume to :
anjar.nofiani@kharismaindo.com
Contact Person HRD :
0813-6081-4304 (Whatsapp)
(Only shortlisted candidate will be notified for interview and selection process)
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