Regulatory Affairs Officer
5 days ago
Ø Acquiring knowledge about regulatory guidance in various countries and various dosage forms and implementing them at the time of filling.
Ø Replying queries to Ministry of Health authorities of African Region.
Ø Maintaining record of registration status and re - registration.
Ø Internal Co-ordination with Mfg. Plant, R&D and QA-QC and medical team for Project execution.
Ø Should coordinate with factory for samples, working standards, document data, license related document
Ø Preparation of text matter and checking of artworks.
Ø Review and prepared all Quality documents like Specifications, protocol, Process validation, BMR
**Job Types**: Full-time, Permanent
Pay: Up to ₹400,000.00 per year
**Benefits**:
- Paid time off
Schedule:
- Day shift
- Monday to Friday
Supplemental Pay:
- Performance bonus
- Yearly bonus
Application Question(s):
- How many dossier you have prepared in 1 month ?
- Which dosage form have you handled?
**Education**:
- Bachelor's (preferred)
**Experience**:
- ROW: 1 year (preferred)
**Location**:
- Andheri, Mumbai, Maharashtra (preferred)
Work Location: In person
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