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
