Earam Kausar Email & Phone Number

Currently, I am pursuing a Master of Science in Regulatory Affairs (Drugs, Biologics, and Medical Devices) at Northeastern University, Boston, USA, while gaining hands-on experience as a Regulatory Affairs Specialist Intern at a medical device start-up company.I am a skilled regulatory professional with extensive experience in the pharmaceutical and medical device industries. My expertise encompasses eCTD regulatory submissions, publishing, and validation of MAA, PSUR, Type IA/IB/II variations, and responses via CESP to European regulatory authorities. I have experience in dossier preparation (CMC) in aCTD format for Southeast Asian countries and CTD format for Global Markets. I have collaborated with cross-functional teams, key stakeholders, and health authorities to address post-approval regulatory queries and secured product registrations for international market entry. Additionally, I have prepared and submitted annual reports, supplements, and amendments for submission to regulatory authorities to address gaps/discrepancies.In the medical device domain, I have drafted 510(k) Pre-market Notifications, Technical Files, Breakthrough Designation Dossiers, Declarations of Conformity, and cybersecurity design inputs, including threat modeling and risk management reports. Prepared and drafted CAPAs, Non-Conformances, change control processes, and the creation and revision of SOPs. I have also provided guidance on global compliance requirements such as CE Marking and product registrations. I have drafted and reviewed package labeling/IFU content for seamless submissions.My technical expertise includes proficiency in tools such as Microsoft Office (PowerPoint, Word, Excel, Google Docs), Atlassian Confluence, Jira, Liquent Global Insight, ISI ToolBox, Liquent Insight for Viewing, ADAM, Lorenz Validator, Extedo EURS Validator, and the Argus database for deliveries.I possess in-depth knowledge of pharmaceutical product lifecycle management, regulatory strategies, and compliance with global regulations, including cGMP, GLP, and GCP standards. I am well-versed in IND, NDA, ANDA, PSUR, 510(k), PMA, ISO 13485, ICH guidelines (Modules 1-5), and 21 CFR (Parts 210, 211, 201, 314, 315, 600, 601, 820, 821, 822). I have collaborated with regulatory authorities, including FDA, WHO, EMA, MOH, GCC, and The Pharmacy and Poisons Board. My experience also includes working with EMA National/MRP/DCP procedures, FDA Form 1571, informed consent processes, and pharmacovigilance.