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 (Good Manufacturing Practices).
- Technical: Experience with electronic Common Technical Document (eCTD) software.
- Traits: Extreme attention to detail and strong written communication.