Lowongan Regulatory Affairs Officer (KALBE Group) di PT Bifarma Adiluhung

REQUIREMENTS:

• Candidate must possess at least Bachelor's Degree in Pharmacy or equivalent.
• At least 1 Year of working experience in the related field is required for this position.
• Understand CTD/ACTD, AMDD and CDAKB.
• Excellent communicator and deal effectively with all levels/positions.
• Strong leadership and analytical skills.
• English (both oral and written) is a must.

JOB DESCRIPTIONS:

• Prepare product dossier compilation according to suitable CTD/ACTD format, or country specific requirements for the regulatory submission to the Regulatory Authorities/Ministry of Health in a timely manner.
• Actively follow-up (consultation) with Regulatory Authorities/Ministry of Health on the regulatory submissions and approvals.
• Liaise with registration consultants/distributors to ensure they deliver the service as stated in the agreement in a timely manner.
• Provide thoughtful & accurate comments to the Business Development during the document review of the new products pertaining to document content.
• Provide the regulatory support for the Clinical Development operations activities (review of Quality Documents).
• To build good working relationship with the Regulatory Authorities/Ministry of Health, regulatory consultants and distributors.