Glitz  Pharma
Monday 22, May 2023

Regulatory Officer 

Giltz Pharma

Islamabad, Rawalpindi, - Pakistan - Salary Not disclosed

1 Year Morning Shift Full-Time

Job Details

Category:
Manufacturing
Career Level:
Experienced (Non-Managerial)
Experience:
1 Year
Required Qualification:
Pharm-D
Requires Traveling:
Yes
Salary:
Salary Not disclosed
Salary Type:
Per Month
Total Vacancies:
1
Skills
registrationproductmanufacturingarealicenseliferegulatorysupportmedical deviceslocalregulationsglobaldistributionmedicalmanager

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.

Job Specification

Giltz Pharma is in search of talented and motivated individuals for the post of Regulatory Officer in the field of Manufacturing in one of their office located in Islamabad, Rawalpindi - Pakistan. The ideal candidate should have pharm-d qualification and atleast 1 year of experience. The position require registration, product, manufacturing, area, license, life, regulatory, support, medical devices, local, regulations, global, distribution, medical, manager mandatory skills. This is a Full-Time morning shift job.