Regulatory Compliance Officer

Overall Job Purpose:

The Regulatory Compliance Officer assures the compliance of the company with GMP and FDA regulations. He/she reports to the Plant Manager/President any GMP/FDA non-compliance/s requiring higher management decisions. He/she must be responsible for processing FDA, IPO, GSI (barcode), Halal, PDEA, and other regulatory applications.

Job Qualifications:

The Regulatory Compliance Officer must have a Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering or equivalent. He/she must have a thorough understanding of the GMP, FDA, IPO, GS1, PDEA, IDCP (Halal) regulations. He/she must possess excellent communication skills and adept with computer applications.

Duties and Responsibilities:

Gathers dossier for the registration of products with the FDA. Responsible for the submission of registration of the products with the FDA. Ensures that the License to Operate (LTO) is renewed on time. Responsible for all liaison functions with the FDA. Attends regulatory seminars and forums pertaining to the manufacturing and regulation of the product to keep the company abreast and complaint with the standard. Responsible for processing applications for IPO (Trademark, patent, etc.). Responsible for monitoring and updating licenses or certificates issued by the mentioned regulatory agencies.Responsible for all liaison functions with the FDA. Attends regulatory seminars and forums pertaining to the manufacturing and regulation of the product to keep the company abreast and compliant with the standard. Responsible for monitoring and updating licenses or certificates issued by the mentioned regulatory agencies. Responsible for preparing and submitting updated reports to PDEA. Responsible for preparing and submitting 3rd and 5th DAU (Declaration of Actual Use) to IPO. Complies with company rules and regulations. Performs other functions as may be required by the Superior.