Midhat Batool

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

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.

Doctor of Pharmacy (Pharm-D) – Gomal University.