Officer - Regulatory Affairs

• Graduate: B.Pharm, M.Pharm
• 1 Year to 2 Year experience required

Position of RA Officer:

• Preparation, Compilation of the CTD/ACTD dossiers as per the requirement for ROW market.
• Coordinating with different department for relevant documents required for dossier.
• Reviewing of the relevant documents like DMF, Analytical reports, Specification, Process Validation Protocol, Report, BMR,COA, PDR, Stability data.
• Handling queries from the health authority for dossier.

Position of Trainee Officer RA :

• Preparation of CTD/ACTD dossiers as per the requirement for ROW market.
• Coordinating with QA, marketing department for relevant documents required for license, FSC, COPP applications of own and third party products.
• Handling queries related with FDA applications.
• Knowledge of FDA Licensing, COPP,FSC and other miscellaneous applications.
• Visit to FDA office related with licensing.

Job Type: Full-time

Pay: ₹12,000.00 - ₹20,000.00 per month

Benefits:

• Paid sick time
• Paid time off
• Provident Fund

Ability to commute/relocate:

• Navi Mumbai, Maharashtra: Reliably commute or planning to relocate before starting work (Required)

Experience:

• 2year: 1 year (Preferred)

Work Location: In person