Officer Regulatory Affairs

Year    MH, IN, India

Job Description

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

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Job Detail

  • Job Id
    JD4820969
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    MH, IN, India
  • Education
    Not mentioned
  • Experience
    Year