Dr. Irsa Kanwal

MEDICAL FREELANCER

Fiverr • Freiberufler

Jul 2021 - Present • 4 yrs 10 mos

Working on different freelancing portals providing services related to medical article writing, medical presentations designing, medical posters presentations, and medical infographics designing, and making product profiles of different healthcare and medical products.

SENIOR OFFICER-REGULATORY AFFAIRS

MAPLE PHARMACEUTICALS • Vollzeit

May 2018 - Jun 2020 • 2 yrs 1 mo

 Preparation of Product Registration / Renewal Dossiers according to the registration requirements of Drug Regulatory Authority of Pakistan (DRAP) and/or Overseas Regulatory Authorities (Pharmaceuticals / Nutraceuticals ).  Monitoring of registration processes & ensures timely approvals through effective communication with associates.  Response to the queries from DRAP regarding the registration of drug.  Initiate and developed product packaging artworks in accordance with DRAP / Export labeling requirements in coordination with designing dept., QA & Supply chain.  Perform other duties assigned by the Management.  Review of minutes of meeting of DRAP and analyze for the future products.  Maintenance of record files of the registration letters, Renewal letters, DRAP related regulatory documents.  Created new product artworks and also updating already existing artworks as per new guidelines and laws. • Documentation, data management and formation of memo for samples. • Assist management for the compliance of the registration queries received from the drug authorities. • Ensuring company’s products comply with regulation of DRAP. • Responsible for collection and compilation of technical documents for product registration & renewal applications.

OFFICER REGULATORY AFFAIRS

AMARANT PHARMACEUTICALS • Vollzeit

Sep 2016 - Sep 2018 • 2 yrs

 Preparation of Product Registration / Renewal Dossiers according to the registration requirements of Drug Regulatory Authority of Pakistan (DRAP) and/or Overseas Regulatory Authorities.(Pharmaceuticals / Nutraceuticals / Veterinary ).  Response to the queries from DRAP regarding the registration of drug.  Monitoring of registration processes & ensures timely approvals through effective communication with associates.  Coordinate with lawyers in case of any legal matters.  Initiate and developed product packaging artworks in accordance with DRAP / Export labeling requirements in coordination with designing dept., QA & Supply chain.  Perform other duties assigned by the Management.  Review of minutes of meeting of DRAP and analyze for the future products.  To work with other areas of business ensuring necessary lead times are understood in order to deliver a quality proposal.  Processed the whole procedure of Trademark and Copyright of all the products of the company.  Maintenance of record files for the registration letters/ Renewal letters/ Trademarks/ copyright and registration related documents along with proper tagging.  Created new product artworks and also updating already existing artworks as per new guidelines and laws. • Formation of leaf inserts, proof reading and handling issues regarding artworks. • Documentation, data management and formation of memo for samples. • Assist management for the compliance of the registration queries received from the drug authorities. • Ensuring company’s products comply with regulation of DRAP. • Responsible for collection and compilation of technical documents for product registration renewal applications. • Develop pricing model for the launching of new products. • Responsible for identifying, execution, development of new products.