Aysha Rana

Location

New York City, NY
Education
    Northeastern University
    January 2024 - December 2025
    degree
    Master's
    major
    Pharmaceutical and Healthcare Business
    University of The Punjab
Work Experience
    Next Pharmaceutical Products
    Head Regulatory Affairs/Quality/Pharmacovigilance
    Lahore, PK
    October 2022 - December 2023
    company
    Next Pharmaceutical Products
    title
    Head Regulatory Affairs/Quality/Pharmacovigilance
    overview
    - Led expertise in ICH CTD/ACTD registration dossier preparation (20) and compilation for Pharmaceuticals, Biologicals, Nutraceuticals, and Medical Devices, ensuring successful product - Ensured strict compliance with regulations and standards set by DRAP, MHRA, WHO, PIC/S, USFDA - EMA, PMDA, ISO, ICH, and ISPE guidelines, maintaining a high level of quality assurance across all - Negotiated with regulatory authorities, developed Regulatory Strategies, analyzed scientific and legal - Gathered and reported adverse drug reactions, prepared PSURs, and managed all Pharmacovigilance - Managed operational requirements, conducted risk management, provided expertise during audits and inspections, monitored regulatory changes, and oversaw documentation management for efficient
    Pharmedic Laboratories
    Manager Regulatory Affairs/Quality/Pharmacovigilance
    Lahore, PK
    July 2021 - September 2022
    Genetics Pharmaceuticals
    Assistant Manager Regulatory Affairs/Quality
    Lahore, PK
    July 2020 - June 2021
    Remington Pharmaceutical Industries
    Senior Officer Regulatory Affairs/Drug Safety
    Lahore, PK
    July 2017 - July 2020
Skills
Languages
EnglishUrdu
Skills
Academic WritingAdverse Drug ReactionsAttention to DetailAuditing SkillsBiopharmaceuticalsBusiness DevelopmentBusiness PlanningClinical ResearchCommercialization SkillsCommunication SkillsCooking SkillsCoordination SkillsCorrective and Preventive ActionDelivery of ProjectsGeneticsInternational SalesInterpersonal SkillsKnowledge of LawsKnowledge of Packaging and ProcessingLabelingLegal KnowledgeManufacturingMarketingMedical MaterialsMedicines and Healthcare Products Regulatory Agency (MHRA) GuidesMicrobiologyMicrosoft AccessMicrosoft ExcelMicrosoft OfficeMicrosoft PowerPointMicrosoft WordNegotiation SkillsPatient SafetyPeriodic Safety Update ReportPharmaceuticalsPharmacologyPharmacovigilancePIC MicrocontrollerPresentationsProblem SolvingProduct DesignProduct LifecycleProject ManagementPunctualityQuality ManagementRegulatory AffairsRegulatory ComplianceRegulatory RequirementsResearch and DevelopmentRisk ManagementSafety PrinciplesSciencesSelf MotivationStakeholder ManagementStandard Operating ProceduresStrategic AlignmentStrategic ThinkingTablet ComputersTeam ManagementTime Management