Waqar A

Sr. Assistant Manager Regulatory Affairs (3rd Party)

Boston Scientific • Temps plein

Sep 2024 - Present • 1 yr 8 mos

I'm a Strategic Regulatory Affairs Expert | FDA, EMA, 510k, PMA Specialist. I'm about getting things done right, and fast. I’ve worked across the board in pharma, and I know my way around product registrations, renewals, and compliance like the back of my hand. Whether it's dealing with authorities or decoding the ever-changing maze of regulations, I’ve got it covered. Core Regulatory Competencies: ✔ Digital Mastery: Expert in DRAP E-Portal submissions and digital licensing. ✔ Compliance & Licensing: DML, GMP- Pharma & H&OTC, DSL, Establishment License for Medical Devices, Form-6 for H&OTC, PSQCA Licensing for Consumer Products. ✔ Technical Documentation: Specialized in CTD Dossier writing and submission. ✔ Pharmaceutical/ Medical Devices/ Biologicals Product Renewals. ✔ Form-7 Herbal & Nutraceutical registrations. ✔ Pricing: Expert handling of CPI cases, New Enterants and Hardship applications. ✔ Getting COPP/FSC certificates from DRAP Lahore. ✔ Help with various kinds of Inspections done by DRAP along with other Departments. ✔ Drafting replies for Drug Inspectors, Testing Labs, DRAP, PQCB, DQCB. ✔ Filing and renewing Drug Sales Licenses. ✔ PSQCA registrations for consumer products. ✔ Extracting useful information from RB, CLB, Misc. Minutes of Meeting.