Assistant Manager Regulatory & Export

Glitz Pharma; Islamabad Capital Territory; On-site; PKR 350,000 - 1,400,000; Full time

Job summary

A pharmaceutical company is seeking a dedicated Regulatory Affairs Associate to manage product registrations and ensure compliance with drug regulations. This role involves timely renewals of licenses, coordinating with other departments, and providing support for approvals. The ideal candidate will have strong attention to detail and organizational skills in a regulatory environment.

Responsibilities

• Manage product registrations and compilations.
• Ensure timely renewal of product registrations.
• Renew drug manufacturing licenses.
• Fulfill regulatory medicine and drug policies.
• Coordinate with other departments.
• Support in packaging and promotional approvals.
• Assist RA Manager with authorizations from DRAP.
• Obtain approvals for changes in registered drug documents.
• Provide support for tender business documentation.
• Perform other tasks as assigned by the RA Manager.
• Update prices of registered drugs as per new regulations.

Job description

New products registration and compilation along with registration of products.

Timely renewal of registration of all products. (both local and export)

Renewal of Drug manufacturing license

Fulfillment of all regulatory medicine and drugs policies

Co-ordination and correspondence with other department/divisions within the company on behalf of own department

Support in approval of packaging, and promotional

Assist RA Manager in procedures for obtaining authorizations and permissions from DRAP or other authorities related to drug regulations

Work to get approvals from DRAP for any change in document of presently registered drugs, (E.g. Change in price, additional pack size, change in packaging components, change in formulation, change in technical staff etc.)

Provide departmental support to all other departments whenever needed for the organization.

Provision of documents for tendor business.

Any other task as assigned by RA Manager.

Work to get approval and to update the price of registered drug according to new SRO’s and intimations of DRAP