Lowongan Pekerjaan

Regulatory Affairs Officer

Full Time

PT Mursmedic

Kota Jakarta Utara, DKI Jakarta, Indonesia

Industri: Kesehatan dan Pelayanan

Ensuring compliance with regulation
Managing to do the whole process of product registration, including but not limited to compiling their required documents, review the documents to check the sufficiency of the content with the local requirement, dossier preparation and submission to the related Health Authority, follow up until the license is approved within the expected timeline
Monitoring and setting timelines for license renewal and amendment to strict deadlines
Consultancy, advocacy and negotiation to the related Government or Authority for any cases related to the regulatory matters
Being updated for any new regulation, guidelines and issues that currently happen and provide strategic advice to the Manager related to project management
Managing the regulatory and quality inspections
Developing quality document regarding work procedures, instructions and manual
Developing quality projects charter, delivering, monitoring and reporting

Fresh Graduates are welcomed
Computer literate, especially in Microsoft Office (Word, Excel, Power Point, etc)
Having excellent communication skills
Good interpersonal skills and attitude
Good analytical thinking and attention to details
Fast learner, hard worker, discipline, creative and pro-active
Able to work in a team as well as work independently
Good in handling the stress of tight deadlines