Monday, May 22, 2023

Regulatory Officer

Regulatory Officer required

Regulatory Officer

Location: Islamabad, Rawalpindi - Pakistan
Salary: 25k - 40k ( PKR )
Experience: 1 Year
Shift Timings: Morning Shift
Job Type: Full-Time

Description: Manage All DRAP Matters regarding registration and re-registration of Company Products
Renewal/extension of product registrations and renewal of manufacturing licenses
Submission of variations related to Area license
Variation applications of labeling changes, extension/deletion in Indication,artworks Extension/reduction in shelf life
Regulatory support for the ongoing/planned Preregistration studies
Prepare, and submit registration dossiers for medical devices registration in the required format.
Follow-up input request from Drug Regulatory Authority of Pakistan to ensure successful product registration.
Submit supplementary for approved products when there is an update of the dossier.
Ensure local regulations are observed and implemented within the company.
Coordinate with global regulatory and DRAP for all regulatory-related issues.
Assist in preparing the GDPMDS (Good Distribution Practice for Medical Devices) audit.
Maintain the PMDR (Pakistan Medical Device Register) Listing for approved products.
Any task given by immediate manager.

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