Assistant Manager Regulatory & Export

Responsibilities :

Register new products and compile registration documentation.

Ensure timely renewal of registration for all products (local and export).

Renew drug manufacturing licenses.

Ensure compliance with all regulatory policies related to medicines and drugs.

Coordinate and communicate with other departments within the company on behalf of the regulatory affairs department.

Support in the approval process for packaging and promotional materials.

Assist the RA Manager in obtaining authorizations and permissions from DRAP or other relevant authorities related to drug regulations.

Facilitate approvals from DRAP for changes in registered drug documents, such as price adjustments, pack size modifications, packaging component changes, formulation updates, or changes in technical staff.

Provide departmental support to other departments as needed.

Prepare documents required for tenders.

Perform any other tasks assigned by the RA Manager.

Work to get approval and update the price of registered drugs according to new SROs and DRAP notifications.

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