Regulatory Affairs Associate (Medical Allied Graduate)

Regulatory Affairs Associate (Medical Allied Graduate)

Join to apply for the Regulatory Affairs Associate (Medical Allied Graduate) role at Ambica International Corporation.

A Regulatory Affairs Associate will work collaboratively with all members of the Regulatory Department. He/She acts as the responsible person in filing regulatory documents submitted and received from the FDA. He/She will also be the one who will update Regulatory Reports, which he/she will regularly send to all members of the Regulatory Department for their reference.

Job Responsibilities

• Responsible in updating and ensuring the correctness of Regulatory Reports (Reg PCPR and CLIDP Status, GMP List, CLIDP Report, PCPR Report.) and ensures consistency with the Soft and hard copies.
• Scans and updates the Regulatory Server for FDA submissions and received documents and responsible in ensuring that there will be no missing document.
• Responsib...