07 Sep
|
Livealth Biopharma
|
Navi Mumbai
07 Sep
Livealth Biopharma
Navi Mumbai
A Pharmaceutical License Executive (Regulatory Affairs 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: Bachelors degree in Pharmacy (B. Pharm) or Life Sciences.
- Experience: 5 to 7 years in pharmaceutical regulatory affairs.
📌 Walk-in || Drug Regulatory Affairs Executive (Navi Mumbai)
🏢 Livealth Biopharma
📍 Navi Mumbai