Midhat Batool
Pharmacist
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About
As a Pharmacist in Research & Development (R&D) and Regulatory Affairs, I develop new medicines and ensure they meet global safety standards. In R&D, I work on improving how drugs are made, tested, and delivered to patients.
In Regulatory
Affairs, I handle approvals by following rules from agencies like the FDA and EMA. I work with different teams to take a drug from the lab to the market safely and efficiently. My role combines scientific innovation with legal compliance to bring effective and approved medicines to patients
Experience
Regulatory Affairs Expertise
Manager/Assistant Manager Regulatory Affairs (Evolution Pharmaceutical, 2023–Present):Led DRAP compliance, product registrations, and regulatory submissions (Form 3, ACTD dossiers, renewals).
Managed fast-track approvals for new molecules, toll manufacturing dossiers, and export/local renewals.
Coordinated audits, ensured adherence to DRAP guidelines, and handled pricing/costing for new drugs.
Officer Regulatory Affairs (Herbion Pakistan, 2021–2023):
Prepared CTD dossiers, scientific/medical documentation, and maintained quality assurance systems (GMP, ISO9001).
Production & Operations
Production Officer (Bio-Labs, 2020–2021):Oversaw syrup/suspension/tablet manufacturing, ensuring compliance with DRAP Act 2012, CGMP, and ISO9001.
Core Skills
DRAP regulations, dossier preparation, regulatory writing, GMP compliance.Project management, cross-functional teamwork, and multilingual communication (English/Urdu).
Education
Doctor of Pharmacy (Pharm-D) – Gomal University.Education
Doctor of Pharmacy (Pharm-D) – Gomal University.
