A Pharmaceutical License Executive (DRA Executive) manages legal permissions for manufacturing and selling medicines. They ensure company practices align with government health regulations.
Core Responsibilities
Regulatory Compliance
Prepare license applications for recent pharmaceutical products.
Renew existing manufacturing, marketing, and distribution licenses.
Compile technical documentation for product registration dossiers.
Submit accurate data packages to health authorities.
Liaison & Communication
Coordinate with government drug regulatory bodies directly.
Respond to official technical queries and audit findings.
Advise internal manufacturing teams on compliance standards.
Track changes in local and international pharmaceutical laws.
Documentation & Quality
Maintain a secure archive of all valid licenses.
Review product labels, packaging,
and inserts for legal compliance.
Verify Certificate of Pharmaceutical Product (COPP) documents.
Support internal audits to prepare for official inspections.
Key Requirements
Education & Experience
Degree: Bachelor’s degree in Pharmacy (B. Pharm) or Life Sciences.
Experience: 5 to 7 years in pharmaceutical regulatory affairs.
Skills
Knowledge: Deep understanding of drug acts and GMP (Valuable Manufacturing Practices).
Technical: Experience with electronic Common Technical Document (eCTD) software.
Traits: Extreme attention to detail and robust written communication.