Saima.S

Manager Regulatory Affairs

Mar 2021 - Jun 2022 • 1 yr 3 mos

Working for Medical Device Distributor in Karachi, Pakistan, my responsibilities included: Correspondence with manufacturers to arrange documents for custom clearance and Import permits. Development and compilation of clear explanatory DRAP (Pakistan Regulatory Authority) documents for product Licensing, renewals, notifications or variations. Preparing and applying for Licenses / permission to import products. Keeping track of renewal deadlines and managing their timely submissions. Follow up on submission of registration dossiers at DRAP. Maintenance of a close liaison between company management and key authorities at DRAP. Keeping up to date information with DRAP’s latest regulatory notifications and ensuring company and its products comply with all the latest regulations & guidelines. Notification & submission of change & variations. Implementing Quality Management System & Good Distribution Practice of Medical Devices. Making Standard Operating Procedures, Work Instructions and Forms. Managing and preparing for company inspections, dealing with inspectors. Working with product development team to introduce new products. Preparing tenders voluntarily as an additional responsibility and providing all necessary documents for tender compilations. Occasionally visiting hospitals/ institutions in case of product related queries/ presentations. Achievements: Qualified PQOD 2022& Sindh Prequalification 2022

Regulatory Affairs Specialist

Jun 2018 - Dec 2020 • 2 yrs 6 mos

Working with Alcon, a global leader in eye care, as their sole Regulator in Pakistan, my duties included: Running the Regulatory Affairs department single handedly. Functional reporting to Regional Regulatory Affairs Head in Singapore & Operational reporting to Country Head in Pakistan. Working on renewals, re-registrations and submissions as planned, ensuring no license gap. Building strong communication channel with distributor and Alcon team to support projects, minimize query responses and enhance faster approval timelines. Following up through a tracker person in Regulatory Authority (DRAP) head office in Islamabad. Corresponding with global/regional teams by keeping track of changes, explaining requirements, making drafts and collecting documents from each site. Working with product development team to introduce new products and re-establishing old products by evaluating options, helping define risk & consequences that may emerge with new DRAP registrations & regulations. Achieving the Pakistan transitional submissions and approvals according to plans with no customer disruption after Novartis-Alcon Split. Completion of trainings, along with assessment of knowledge, skills and competency to attain defined learning objectives and then implement in required areas for individual excellence. Achievements: Found a way to counter loss of currency difference by transferring Drug Registrations to Medical Device/ OTC for company profit. Alcon was the first to register Intraocular lenses in Pakistan during my tenure.

Senior Officer Regulatory Affairs

Jul 2017 - Jun 2018 • 11 mos

Medical Device Distributor Division. Karachi, Pakistan. Applying for Company Enlistment Correspondence with manufacturers Preparing & applying Import Dossiers Follow up with DRAP Implementing Quality Management System & GDPMD Designing company’s Quality Manual and Site Master File. Applying for Punjab Govt. Prequalification (PQOD). Forming company’s Organogram, Policies and Job Description of employees. Making Standard Operating Procedures, Work Instructions and Forms. Assisting in company inspections, dealing with inspectors. Pharmaceuticals Manufacturing Division. Karachi, Pakistan Preparing Local Dossiers, new product dossiers & Import Dossiers