Regulatory Affairs Executive

Althera Laboratories India Pvt Ltd, Mumbai; Mumbai; Sur place; INR 1 200 000 - 2 400 000; Plein temps

Résumé du poste

Althera Laboratories India Pvt Ltd, Mumbai is seeking a regulatory affairs professional to manage dossier assembly, renewals and variation packages for Emerging markets. You will archive approved certificates, health authority letters, and final labels in the internal tracking database, and provide flexible support across regions depending on launch volumes and deadlines.

The ideal candidate has 3 to 6 years of regulatory experience, knowledge of ICH guidelines, and familiarity with CTD, ACTD or

Qualifications

• Experience: 3 to 6 years in regulatory affairs.
• Knowledge of ICH guidelines and relevant regulations in Emerging markets.
• Familiarity with compiling basic submission formats (CTD, ACTD or local formats).

Responsabilités

• Dossier Assembly: Compiling, formatting, and preparing registration dossiers, renewals, and variation packages.
• Database Archiving: Uploading approved certificates, health authority letters, and final labels into the internal tracking database.
• Flexible Support: Shifting operational support between different regions of Emerging markets depending on launch volumes and pipeline deadlines.

Connaissances

Regulatory affairs

ICH guidelines

CTD/ACTD formats

Description du poste

Key Responsibilities:

• Dossier Assembly: Compiling, formatting, and preparing registration dossiers, renewals, and variation packages.
• Database Archiving: Uploading approved certificates, health authority letters, and final labels into the internal tracking database.
• Flexible Support: Shifting operational support between different regions of Emerging markets depending on launch volumes and pipeline deadlines.

Expectations:

• Experience: 3 to 6 years in regulatory affairs.
• Knowledge of ICH guidelines and relevant regulations in Emerging markets
• Formatting Skills: Familiarity with compiling basic submission formats (like CTD, ACTD or local formats).