Dossier Development (Regulatory Affairs Dept.)

PT Kalbe Farma Manufacturing ( Kalbe Farma Tbk )

PT Kalbe Farma Manufacturing ( Kalbe Farma Tbk ) (East Jakarta, Jakarta)

DKI Jakarta, Indonesia

PT Kalbe Farma Tbk, or simply known as Kalbe, is an Indonesian pharmaceutical, healthcare and nutrition company established in 1966. The company has expanded by strategic acquisitions of pharmaceutical companies, becoming an integrated consumer health and nutrition enterprise.

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Job function: Legal & Compliance

Industries: Food Ingredients and Flavourings

About this position

The placement is at Kalbe subsidiary PT. Bifarma Adiluhung, located in Pulo Gadung, East Jakarta.

Responsibilities

• Prepare product dossier compilation according to ICH-CTD/ACTD/AMDD or other related format for regulatory submission to the Regulatory Authorities/Ministry of Health in a timely manner.
• Provide thoughtful and accurate comments to related dept. during the document review of the new products or project pertaining to document content.
• Manage Regulatory Submission and Approval for Certification (CPOB, CPAKB, CDAKB) in a timely manner.
• Actively follow up (consultation) with Regulatory Authorities/Ministry of Health.
• Manage SOP for RA SBU Biopharma.

Requirements

• Candidate must possess at least Bachelor's Degree in Pharmacy or equivalent.
• Understand CTD/ACTD, AMDD, CDAKB, CPOB and CPAKB.
• Excellent communicator and deal effectively with all levels/positions.
• Strong leadership and analytical skills.
• Can deal with strict deadline.
• English (both oral and written) is a must.
• Preferably experienced in the field of regulatory affairs (internships experience are allowed).
• Fresh Graduate are welcome to apply.

Benefits

Huneety A.I Salary Estimate

11,000,000 - 35,000,000 IDR per month