A motivated registered Pharmacist with a real passion for healthcare. Excellent track record of maintaining positive relationships with patients, Pharmaceutical representatives, medical professionals, manufacturers, and health care organizations. Ability to advise patients on medication brands, medication storage, adverse effects, and interactions. Able to complete documentation for products registration in DRAP and foreign correspondence.
Working as a Regulatory Affairs Specialist at Core Diagnostics Division Islamabad of Abbott Laboratories Pakistan Limited
Responsibilities:
Provide support for Regulatory Affairs related issues to ensure compliance with regulatory requirements & Abbott Quality System regulations.
Maintain Technical Documentation for products.
Provide update and maintain status of product registrations and notifications.
Provide the required information including legal documentation for country specific Regulatory Affairs contacts to enable and maintain product submissions
Provide, as required, regulatory input and approval for changes and classification of changes to Device Master Records, Quality System records, labeling, etc.
Provides support for regulatory processes and procedures.
Maintains current registrations by preparing documentation required and submitting documentation on schedule as directed.
Completes daily work to meet established schedule with guidance from Manager on prioritization of tasks.
Medical and regulatory terminology
Regulatory history, guidelines, policies, standards, practices, requirements and precedents
Regulatory agency structure, processes and key personnel
Principles and requirements of applicable product laws
Support and assist the Manager to implement to ensure no business interruption arising from the implementation of the Medical Devices Rules.
Liaise with the International RA Department staff. Implement databases and tracking tools to ensure projects, commitments and reporting requirements are adhered to.
Liaise with the Abbott Quality Assurance / Regulatory Compliance Departments as required to answer regulatory queries and ensure that local processes meet regulatory requirements.
Prepare and submit regulatory files and documentation to Regulatory Authorities in accordance with local regulatory requirements.
Working as a Quality Assurance and Regulatory Affair Pharmacist at Global Healthcare (Pvt.) Ltd. Pakistan.
Responsibilities:
Foreign Correspondence to complete documentation for registration of products with DRAP.
Preparation of Dossiers.
Work on local regulations for regulatory affairs and compliance management.
Dealing with external authorities like the Drug Regulatory Authority of Pakistan (DRAP, PQCB)
Quality assurance of products storage, handling, and dispensing.
Product Complain Handling
Revise and update regularly Standard Operating Procedures (SOP) and GDP Protocols.
Focal Person in Coordination for Stock Analysis and Documentation of Warehouse Activities
Coordination with Supply Chain for Replenishment of Stock.
Management of Supply Chain Functions.
Worked as Pharmacist at NIBD (after Pharm D)
Worked as a Quality Assurance Pharmacist.
Worked as a Pharmacy Supervisor at Zubaida Medical Centre Karachi
Worked as a Pharmacist at Memon Medical Institute Karachi.
Major Responsibilities were:
Focal Person in coordination for stock analysis and documentation of the Pharmacy activities
To give pharmacological information for multidisciplinary health care teams and monitor patient drug therapies
Revise and update regularly Standard Operating Procedures (SOP) and Pharmacy Protocols
Coordinating with supply for the replenishment of pharmacy stock
Worked as a Pharmacy Supervisor at Institute of Orthopedic & Surgery Karachi
Major Responsibilities were:
In-patient & Out-patient Dispensing of Medicines.
Focal Person in coordination for stock analysis and documentation of the Pharmacy activities
To give pharmacological information for multidisciplinary health care teams and monitor patient drug therapies
Revise and update regularly Standard Operating Procedures (SOP) and Pharmacy Protocols
Coordinating with supply for the replenishment of pharmacy stock
Meetings with Pharmaceutical Representatives.
Floor Stock Management.
Patients Pharmacy Billing.