Drug Regulatory Affairs job openings – Noida

Drug Regulatory Affairs job openings – Noida

Company name; ASMOH LAB LTD

job type – full time

KEY RESPONSIBILITIES:

• To be responsible for the Life Cycle Management of assigned products, preparation of pharmaceutical/quality part (all forms) of registration dossiers and variations/amendments/annual reports as applicable documents in CTD and ACTD format according to WHO GMP ISO regulatory requirements.
• To prepare dossiers according to the different countries’ guidelines.
• To write, check/review documents as per regulatory requirements. To prepare the checklist of the document.
• Publish software submission documentation as per regulatory requirements.
• To respond to regulatory deficiencies letters according to different countries’ regulatory requirements.
• To support local in-licensing. To collaborate with other departments/partners. To maintain lists/documents/records.
• To achieve his/her responsibilities within the agreed timescales.
• To actively participate in the development of regulatory skills within the regulatory team by continuously updating. Compilation of dossiers for different countries under third-party manufacturing or contract manufacturing.
• Preparation of BMR, Stability, Analytical methodology, and dissolution Method.
• Preparation of Artwork.
• Product Development under registration guidelines as per different countries. To prepare Periodic Safety Update Reports (PSUR) & PDRs for all dossiers To maintain the record of Product Permission & COPP To maintain the records of all samples released from the plant for the different countries.

Drug Regulatory Affairs job openings – Noida APPLY HERE

Drug Regulatory Affairs job openings – Noida