Headline

Regulatory Affairs Specialist|QPPV|Scientific Office Pharmacist |Medical Devices |Product Specialist|Pharmaceutical |Market Access|

About

I am a dual-qualified Regulatory Affairs Specialist and Pharmacist In Charge at Bayan Medical, UAE — bringing together deep regulatory expertise, pharmacovigilance leadership, and a meticulous commitment to quality across the full product lifecycle. 📊 Key impact metrics: • 2 Regions managed: AFMET & US/EU markets • 100% GSP & GDP compliance adherence • QPPV designation held — full PV system ownership • Dual product verticals: medical devices & medicines At Bayan Medical, I oversee the registration and lifecycle management of medical devices and medicines, ensuring every product meets the stringent quality, safety, and vigilance standards required in the UAE/Oman market. My role spans regulatory strategy, submission management, post-market surveillance, and cross-functional coordination — translating complex compliance requirements into operational clarity for the teams I work with. Prior to this, as Scientific Office Manager and QPPV at Lavasta Pharma (Riyadh Pharma), I led pharmacovigilance operations with full ownership of ADR/AE case reporting, signal detection, and PV documentation. I managed regulatory and supply chain dynamics across the US, EU, and AFMET regions — an experience that sharpened my ability to navigate multi-jurisdictional frameworks with precision and ethical integrity. 🏆 Career impact highlights: • Medical device & medicine registration at Bayan Medical — zero compliance gaps maintained • QPPV designation at Lavasta Pharma — full PV system governance and ADR/AE oversight • Multi-market regulatory coverage across US, EU & AFMET • PV documentation expertise: PV plans, RMPs, and periodic safety reports to international standards 🔑 Core expertise: Regulatory Affairs (UAE/Oman/KSA) | Pharmacovigilance (QPPV) | GSP & GDP Compliance | Medical Device Registration | ADR/AE Case Reporting | Product Lifecycle Management | PV Documentation | Supply Chain Regulatory | AFMET Region | Ethical Pharmaceutical Leadership I am committed to raising the standard of regulatory practice in the region — combining scientific rigor, ethical leadership, and a hands-on approach to compliance. If you are working in pharmaceutical regulation, medical device registration, or pharmacovigilance in the MENA region, I would be glad to connect.

Location

Dubai

Work experience

Regulatory Affairs & PV Specialist at Bayan Medical Company, Jan 2024 - Present · 2 yrs 6 mos, Dubai, United Arab Emirates, Registration of manufacturing sites, medical devices, conventional medicines, and GSL products with MOHAP/EDE. Managing product classification and liaising with MOHAP/EDE for import permits, batch releases of biologicals, and shipment clearances. End-to-end product lifecycle management of drugs and devices, including handling minor variations and renewals. Ensuring compliance with Good Storage Practices (GSP) and Good Distribution Practices (GDP). Pharmacist In Charge for the Medical warehouse. Handling Brandsync ,Tatmeen portal operations for product traceability. Securing DDC and HAAD codes. Managing MOFA attestations for import and export documents. Leading pharmacovigilance (PV) activities: adverse event/ADR reporting, recalls, market withdrawals etc. Acting as the regulatory liaison in the UAE & Oman for global healthcare and medical device companies, including: Medtronic,Medartis,GE Healthcare,BBraun AesculapBien-Air,Sanochemia,Magstim,Peters Surgical,Artivion Jotec,Geister,Sophysa,Sinapi,Transonic,Schaerer Medical AG,TIDI,Vostra.

Scientific Office Manager & QPPV at Lavasta Pharma, Aug 2020 - Jan 2024 · 3 yrs 6 mos, Dubai, United Arab Emirates, PV documents preparation: Preparation, review, approval and timely revision of Pharmacovigilance System Master File (PSMF), Pharmacovigilance Sub System File (PSSF), PV Plan, SOP. Active reporting of ADR/AE Cases: Collection, review, evaluation and reporting. • Performing Post Marketing Studies and evaluation of PMS reports. • Effective review and approval of Pharmacovigilance systems and documents of AFMET region. • Holding the UAE Scientific Office Pharmacist Responsibilities and QPPV in MOH for Lavasta/Riyadh Pharma. • Supply Chain Operations from US/EU market to AFMET region.Liaising with suppliers(GulfDrug,MPC & Pharmalink )for UAE regulatory and supply chainOperations. •Document preparation for import/export.Coordinating with Manufacturing site,Suppliers & Shipping agent. • Managing approval of products in Brand sync and Tatmeen MOH portal for UAE. • Product Specialist for few key accounts like Med7,Acorus,NMC,Sharjah & NE handling Riyadh Pharma/Lavasta Products. Products Handled-Clarimac,Rumafen,Zertazine,Lorahist,Waxol,Pyralvex,Xylomet, Lavonda,Ciprogen,Glacera & Vascodipine.

Senior Pharmacist at AVIVO Group, Jan 2019 - Aug 2020 · 1 yr 8 mos, Dubai, United Arab Emirates, • Established clear and effective customer service policies to increase satisfaction and pharmacy loyalty. • Effectively managed pharmacy budgets through inventory management. • Trained and mentored junior pharmacy staff to increase team productivity and efficacy. • Improved organisation and supply management policies for all medicines and materials.

Pharmacist at AVIVO Group, Dec 2017 - Jan 2019 · 1 yr 2 mos, Dubai, Dubai, United Arab Emirates, • Received prescriptions and checked against medical histories, safeguarding patient health and safety. • Oversaw secure, appropriate storage of temperature-sensitive items and controlled substances. • Collaborated effectively with hospital staff to maintain patient care continuity.

Production Chemist at Sangrose Laboratories Pvt Ltd, Mar 2014 - May 2015 · 1 yr 3 mos, Kerala, India, Accurately evaluates achievement of production plan to objectives based on available resources. Assigns tasks to employees according to their skills. Writes, reviews, and approves documents relevant to management activities (e.g., procedures, deviations, work instructions, master files, and validation reports). Accurately assesses problems. Analyses and evaluates options. Makes sound recommendations to improve productivity, solutions to issues affecting quality, and health and safety.

Hospital Pharmacist at SREEKANDAPURAM HOSPITAL, Jul 2013 - Dec 2013 · 6 mos, Kerala, India

Education

Master's degree, Pharmaceutics and Drug Design, SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES, COLLEGE OF Pharmacy (Inst. Code - 034), COIMBATORE

B.Pharmacy, Pharmaceutical Sciences, PUSHPAGIRI College of Pharmacy