Candidate Information Title Regulatory Affairs, Pharmacovigilance, Manager or Senior Associa Target Location US-NY-Bronx Email Available with paid plan	20,000+ Fresh Resumes Monthly     View Phone Numbers     Receive Resume E-mail Alerts     Post Jobs Free     Link your Free Jobs Page     ... and much more Register on Jobvertise Free
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I am a Regulatory Affairs professional in pharmaceutical product, clinical trials, medicaldevice registration, advertising, post-approval changes, and drug safety that has excelled as a specialist within the EU and West Africa over a period of 7 years. I am proficient in the use of regulatory databases, clinical trial and regulatory management tools, having honed my skillset in regulatory reporting and provision of country-level regulatory oversight. I possess some exposure to the US regulatory environment, partnering with companies like Lunovus on current Good Manufacturing Practice applications to the FDA. Now, I currently seek associate and specialist-level roles within the US regulatory market. I am an attentive team player and effective collaborator who is passionate about contributing effectively to the growth of people and organizations.- Successfully managed regulatory lifecycles of 41 drug products from clinical trial and development to market authorization, growth and post-approval changes. These were solid dosage forms, biologics and medical devices.- Successfully filed and obtained approvals on regulatory applications across various global regulatory territories, specifically: US FDA, EU/EEA, EMEA, ASEAN, LATAM, pertaining to clinical trials, marketing authorizations and post-approval changes.- Managed processes and published documents that led to GMP/GDP approvals of factory sites and warehouses of contract manufacturers in the US and across the EU, providing regulatory oversight of product CMCs and sundry quality management systems.Equality & Diversity Tutor,Evolve Academy (June 2023  July 2024)(United Kingdom)- Delivered full-time lectures and case studies on cultural diversity, social inequalities, equitable actions, racial relations and individual identity  examining how these impact communities and workplaces.Learning SpecialistCoyle Personnel (Mar 2023  June 2023)(United Kingdom)- Design and delivery of educational curricula to guarantee learning outcomes of skilling, knowledge and capacity building in young professionals and students PROFILE SUMMARYTaiwo Salisu(First name is Taiwo, pronounced as Tie-Woe)+19294610788 EMAIL AVAILABLE Spuyten Duyvil, Bronx, NY https://LINKEDIN LINK AVAILABLEHIGHLIGHTSCareer break(Nov 2022  Mar 2023)(United Kingdom)- Undertook career development trainings andinstructional modules from MHRA (yellowpages), EMA (CTIS, EudraCT), ICH-GCP, ICH-Efficacy Guidelines and allied materials onregulatory strategy and business management.- Utilized this phase to evaluate and repurposecareer goals and work expectations.Senior Regulatory Affairs & Vigilance Specialist(Liaison to Lunovus, Panpharma Fr, Ethypharm, Tubilux, LDCollins)Alpha Pharma Ltd (Jan 2020  Nov 2022)(Nigeria & United Kingdom)- Provided country-level regulatory oversight ofseveral portfolio products, returning periodicsafety updates to manufacturing sites, clinical trial partners and authorities.- I undertook clinical trial and product registration operations with local and global RegulatoryAuthorities (FDA, MHRA, EU) through documentand application preparation, technical review ofproduct dossiers in Common Technical Documentformat (eCTD), product profiling, progress reports and periodic experience reports.- Provided technical documentation for StudyStart-ups, Clinical Trial Authorizations (Part 1 & 2), Periodic Safety Update Reports (PSURs),Periodic Benefit-Risk Evaluation Reports(PBRERs) on behalf of trial sponsors andpartner manufacturers of concerned products.These included IND Dossiers, Patient & SiteConsent Forms, Feasibility Questionnaires,Study Protocols, Lay Summaries and SOPs.- Adapted different product labelling,promotional material and content to meetrequirements of several regulatory territorieswithin and beyond the US, specifically LATAM,MENA and Asia Pacific regions.- Provided review and regulatory assessment ofadvertisements for approval with regulatoryauthorities, ensuring timely approval of medicinal products and/or release of technical files andcontinued approval of marketed products.- Successfully assessed and filed product variation Regulatory Strategy & Tactics Clinical trial applications e-CTDS Marketing Authorization Applications &Renewals Product lifecycle management Product label management Regulatory CMC Post-approval changes Medical Device Regulations Labelling Lifecycle Management Study Start-up Clinical Trial Management Systems Pharmacovigilance Good Manufacturing Practice Good Clinical Practice Good Distribution Practice Project Management Veeva RIM Microsoft Office Suite (incl. Project) Risk assessment & Management. Regulatory affairs & Compliance. Statistics & Data Visualization. Business AnalyticsAbbreviated New Drug Application
ANDA (FDA)Common Electronic SubmissionsPortal (EMA)Medicines & Healthcare ProductsRegulatory Authority (MHRA)Integrated Research ApplicationSystem (IRAS)MHRA GatewayICSR PortalEuropean Medicines Agency (EMA)Clinical Trial Information SystemUniversity of PennsylvaniaRegulatory & Compliance CourseSpecialization (2020)Electronic Common TechnicalDocument (eCTD)MasterControl Clinical Excellence;Clinical Trial Information SystemSKILLSSPECIAL COMPETENCIESapplications for biologicals, solid dosage formsand parenteral solutions for acquired productsfrom companies.- Participated in significant product plandevelopment, implementation, evolution ofregulatory strategy, risk management and qualitymanagement systems.- Provided regulatory advice and securedprerequisite licensing approvals for marketing and research teams, providing representation as well.[Clinical Specialist  Tabade Pharmaceuticals (Nov 2019  Jan 2020)] Medilab Pharmacare Ltd. (May 2016  Oct 2019)(Nigeria) Senior Regulatory Affairs Specialist, (2018)(Liaison to global pharma partners)- Undertook new line management responsibilities of managing 2 specialists on submissions and helped guide strategies of higher leadership into actionable departmental tasks. Regulatory Affairs Specialist (2017)- Initiated and obtained approvals for clinical trial and marketing authorization applications across different territories through Common Electronic Submissions and EudraCT (now CTIS) portals, routinely exchanging technical information with authorities and strategy with internal stakeholders.- Exploited Mutual Recognition (MRP) and Decentralized pathways (DCP) to obtain approvals for generics.- Interpreted provisions within the Human Medicine Regulations 2012 and used frameworks of legal basis to guide applications.- Advised development and/or marketing teams on technical labeling, appropriate regulations and interpretations.[Clinical Pharmacist, Community Healthcare Institutions (2013  2016)] Regulatory Affairs Specialist,National Agency for Food & Drug Administration and Control(March 2012  March 2013)(Nigeria)- Assisted in advocacy of compliance programs for private pharma and clinical organizations.- Reviewed applications for marketing authorizations, clinical trials, good manufacturing practices and variations.- Developed risk assessment skills in appraising regulatory risks of private companies, institutions, technical committees, study groups and individuals within regulated territories.[Clinical Pharmacist, Community Healthcare Institutions (2011  2012)] Master of Regulatory Affairs, [Attending]Perelman School of Medicine, University of Pennsylvania, 2023  2026(Distinction in Quality Assurance)Product Management Career Accelerator, [Post-Graduate Certificate] Kings College, London, 2024(Distinction in Product Management & Strategy; Launching Products to Market) Managerial Economics & Statistics for Business Specialization, [Graduate Certificate] Gies College of Business, University of Illinois at Urbana-Champaign, 2022 Bachelor of Pharmacy, University of Lagos, 2011(Distinction in Medicinal Chemistry; Introduction to Tropical Diseases)