Experience

CCL

• Pharmacist



CCL (Pvt) Ltd.

• Lahore

• Senior Officer Regulatory Affairs

  • Jun 2015 - Present

  Drug Registration Pakistan:  Handling of local / Export regulatory affairs especially dossier preparation (Drug registration and renewal of registration).  Responsible for preparing or supervising the preparation of regulatory submissions to DRAP.  Document finalization and registration of local and export dossiers and follow up registration status. Documentation: 1. Maintenance of Registration certificate file & Renewal Status of the Products. 2 Execution of change alert 3. Preparation of Monthly Report & Monthly Minutes 4. Listing of documents. Export Registration :  Preparation of dossiers for international regulatory bodies on CTD format.  Preparation of dossiers for other international regulatory bodies especially Kenya, Tanzania, Union of Myanmar, Cambodia, Tajikistan, Nigeria, Vietnam according to the list of products provided by export division .  Responsible for providing regulatory support to marketed products to maintain compliance to conditions of approvals. This includes reviewing proposed changes to label materials, product, specifications, and methods, manufacturing process and other changes.  Provide guidance to functional groups on regulatory and data requirement to secure approval for the proposed changes. Prepare or supervise preparation of submissions and reports for DRAP product status. Art Work :  Supervise/read the proof of the text of new or improved art-work for labels, outer pack and other literature of products and indicate the corrections and changes. Show less



Indus Pharma(Pvt) Ltd.

• Karachi

• Regulatory Affairs Executive

  • Sep 2011 - Feb 2015

  Drug Registration Pakistan:  Handling of local / Export regulatory affairs especially dossier preparation (Drug registration and renewal of registration).  Responsible for preparing or supervising the preparation of regulatory submissions to DRAP.  Document finalization and registration of local and export dossiers and follow up registration status. Documentation: 1. Maintenance of Registration certificate file & Renewal Status of the Products. 2 Execution of change alert 3. Preparation of Monthly Report & Monthly Minutes 4. Listing of documents. Export Registration :  Preparation of dossiers for international regulatory bodies on CTD format.  Preparation of dossiers for other international regulatory bodies especially Kenya, Tanzania, Union of Myanmar, Cambodia, Tajikistan, Nigeria, Vietnam according to the list of products provided by export division .  Responsible for providing regulatory support to marketed products to maintain compliance to conditions of approvals. This includes reviewing proposed changes to label materials, product, specifications, and methods, manufacturing process and other changes.  Provide guidance to functional groups on regulatory and data requirement to secure approval for the proposed changes. Prepare or supervise preparation of submissions and reports for DRAP product status. Art Work :  Supervise/read the proof of the text of new or improved art-work for labels, outer pack and other literature of products and indicate the corrections and changes. Show less



Indus Pharma(Pvt) Ltd.

• Karachi

• Inetrnship

  • Apr 2011 - May 2011

  Worked as a Internee Worked as a Internee