Asiya Khan
Karachi
Summary
Proactive professional with demonstrated leadership abilities, strategic planning expertise and problem-solving acumen. Assists senior managers with accomplishing demanding targets by encouraging staff and coordinating resources. Methodical and well-organized in optimizing coverage to meet operational demands.
Overview
10
10
years of professional experience
Work History
Assistant Manager Regulatory Affairs
SAMI Pharmaceuticals (Pvt) Ltd
01.2024 - Current
- Prepare, review, and submit regulatory documents to health authorities for drug approvals utilising export dossiers for Kurdistan, Baghdad, Iraq, Yemen
- Stay updated on global regulatory trends and requirements and oversee all aspects related to export activities.
- Develop and implement regulatory strategies to support product development and lifecycle management from Expressions of Interest (EOI) for WHO Prequalification.
- Lead and coordinate all efforts required for obtaining WHO Prequalification, including documentation and communication.
- Review and validate pricing sheets to ensure alignment with Consumer Price Index (CPI) regulations and standards.
- Assess and review cases related to quota allocations to ensure proper distribution and compliance.
- Prepare detailed Common Technical Document (CTD) dossiers for regulatory submissions.
- Develop and assemble comprehensive export registration dossiers for international markets.
- Review and dispatch registration dossiers for generic drug products in accordance with ACTD (Asian Common Technical Document) guidelines.
- Plan and manage the timelines for preparing and sending drug registration dossiers, ensuring all deadlines are met efficiently.
- Handle all aspects of regulatory affairs, including interpretation of guidelines and implementation of compliance measures.
- Respond promptly and effectively to any discrepancies or issues raised by DRAP (Drug Regulatory Authority of Pakistan) evaluators.
- Review and approve product artworks and Summary of Product Characteristics (SMPCs) to ensure regulatory compliance and accuracy.
- Manage and oversee warrantor portions and Drug Transfer Licensing (DTL) cases, ensuring all requirements are met.
- Supervise the handling of post-registration variation cases and technical transfer projects to maintain compliance and smooth transitions.
Senior Executive Regulatory Affairs
SAMI Pharmaceuticals (Pvt) Ltd
05.2023 - 12.2023
- Develop comprehensive Common Technical Document (CTD) dossiers for regulatory submissions, ensuring all sections are accurately completed and compliant with guidelines.
- Assemble detailed export dossiers for international markets, including all necessary documentation and information for regulatory approval.
- Evaluate and manage the dispatch of registration dossiers for generic drug products formatted according to ACTD (Asian Common Technical Document) standards.
- Strategically plan, monitor, and control the timelines for the preparation and submission of drug registration dossiers to ensure timely and efficient processing.
- Handle all aspects of regulatory matters, including compliance with relevant regulations and guidelines, and address any regulatory issues as they arise.
- Provide timely and effective responses to any discrepancies or issues highlighted by evaluators from the Drug Regulatory Authority of Pakistan (DRAP).
- Assess and approve product artworks and Summary of Product Characteristics (SMPCs) to ensure they meet regulatory standards and accurately represent the product.
- Oversee the handling of warrantor portions and manage Drug Transfer Licensing (DTL) cases, ensuring all regulatory requirements are fulfilled.
- Supervise and manage post-registration variation cases and technical transfer projects to ensure smooth regulatory compliance and transitions.
Manager Regulatory Affairs
FAAS Pharmaceuticals (Pvt.) Ltd
07.2018 - 06.2021
- Achieved Registration of products in local and export
- Had Several visits to DRAP Islamabad for resolving issues related to product registrations.
- Keeping abreast of international legislation & guidelines for registration of generic drug product &export.
- Reviewing and dispatching generic drug product registration dossiers on ACTD format.
- Planning, monitoring and controlling timelines for preparation & dispatch of drug registration dossiers.
- Preparing submissions of changes to approved generic drug products to strict deadlines.
- Collecting, collating and evaluating scientific data and marketing data from IMS.
- Checking and verification of drug product artworks to be launched locally in Pakistan or to be exported Internationally.
- Attaining COPP & FSC by coordinating with DRAP (Drug Regulatory Authority of Pakistan), KCCI/ MOFA/ Embassy of relevant countries.
Assistant Manager Regulatory Affairs
FAAS Pharmaceuticals (Pvt.) Ltd
05.2017 - 07.2018
- Achieved Registration of products in local ministry.
- Developing, compiling, reviewing and dispatching generic drug product registration dossiers on ACTD format.
- Planning, monitoring and controlling timelines for preparation & dispatch of drug registration dossiers.
- Preparing submissions of changes to approved generic drug products to strict deadlines.
- Collecting, collating and evaluating scientific data and marketing data from IMS.
- Developing, checking and verification of drug product artworks to be launched locally in Pakistan or to be exported Internationally.
- Attaining COPP & FSC by coordinating with DRAP (Drug Regulatory Authority of Pakistan), KCCI/ MOFA/ Embassy of relevant countries.
- Also worked for local regulatory and associated issues.
Senior Officer Regulatory Affairs
FAAS Pharmaceuticals (Pvt.) Ltd
03.2016 - 05.2017
- Preparing ‘generic drug product’ and ‘OTC’ type of applications over CTD, ACTD & country specific formats.
- Keeping up-to-date with altering drug registration guidelines and developing feasibility to work on the same having adherence to ICH guidelines.
- Achieved Registration of products in local ministry for Export Purpose.
- Developing, checking and verification of drug product artworks to be launched locally in Pakistan or to be exported internationally.
- Attaining COPP & FSC by coordinating with DRAP (Drug Regulatory Authority of Pakistan), KCCI/ MOFA/ Embassy of relevant countries.
Regulatory Affairs Officer
FAAS Pharmaceuticals (Pvt.) Ltd
09.2015 - 03.2016
- Preparing ‘generic drug product’ and ‘OTC’ type of applications over CTD, ACTD & country specific formats.
- Developing, checking and verification of drug product artworks to be launched locally in Pakistan or to be exported internationally.
- Attaining COPP & FSC by coordinating with DRAP (Drug Regulatory Authority of Pakistan), KCCI/ MOFA/ Embassy of relevant countries.
- Resubmission of previous rejected files for local registration
Regulatory Affairs Officer
Macter International Private Limited
02.2015 - 09.2015
- Prepared Dossiers on CTD Format.
- Prepared technical parts.
- Worked on local regulatory.
- Reviewed art works.
Management Trainee Regulatory Affairs
OBS Pakistan Pvt. Ltd
05.2014 - 07.2014
- Training on development of dossiers. (local/import/export products)
- Renewal of local and import products.
- Proof reading of Artworks. (Outer carton, Foil, Leaflet etc.)
- Work on TM search.
Education
Pharm. D -
Dow University of Health and Sciences
Karachi, Sindh01.2013
HSC -
Bahria College N.O.R.E 1
Karachi, Sindh01.2008
SSC -
Hyderi Public School
Karachi, Sindh01.2006
Skills
- Good Communication and Writing Skills
- Excellent Computer skills including MS Office, Internet Searching etc
- Expert in problem-solving
- Believe in team work with good time management
- Workload Management
- Staff Training and Development
- Strategic Planning
- Project Management
- Team Leadership
Extracurricular Activities
Received certificate by DUHS on Osteoporosis Participated in DCOP Poster competition Attended a Seminar on Alzheimer disease (By MeraGhar Foundation) Clinical Rounds in Civil Hospital and OJHA Hospital
Projects
Project on Human Digestive System Project on Analytical Chemistry Project on Parts of Prescription
Training
BSN Medical (Pvt.) Ltd, To understand the working of different departments and their role in maintaining standard and environment of multinational pharmaceutical industry.
Timeline
Assistant Manager Regulatory Affairs
SAMI Pharmaceuticals (Pvt) Ltd
01.2024 - Current
Senior Executive Regulatory Affairs
SAMI Pharmaceuticals (Pvt) Ltd
05.2023 - 12.2023
Manager Regulatory Affairs
FAAS Pharmaceuticals (Pvt.) Ltd
07.2018 - 06.2021
Assistant Manager Regulatory Affairs
FAAS Pharmaceuticals (Pvt.) Ltd
05.2017 - 07.2018
Senior Officer Regulatory Affairs
FAAS Pharmaceuticals (Pvt.) Ltd
03.2016 - 05.2017
Regulatory Affairs Officer
FAAS Pharmaceuticals (Pvt.) Ltd
09.2015 - 03.2016
Regulatory Affairs Officer
Macter International Private Limited
02.2015 - 09.2015
Management Trainee Regulatory Affairs
OBS Pakistan Pvt. Ltd
05.2014 - 07.2014
Pharm. D -
Dow University of Health and Sciences
HSC -
Bahria College N.O.R.E 1
SSC -
Hyderi Public School
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