Regulatory Affairs Executive

3 days ago

Aurangabad, India Bitwise Solutions Full time

**Responsibilities**
- Life cycle management and Maintenance of regulatory filings including annual reports and supplements to US FDA.
- Preparation of registration submissions, in CTD (Clinical Trial Dossier) format, for biopharmaceutical products for approval by the US FDA, European Regulatory Authorities and worldwide, as required.
- Monitoring the progress of registration submissions, responding to queries and ensuring that registration approvals are granted without undue delays.
- Regulatory Compliance, for change control activities monitoring the impact of changes in regulatory submissions.
- Monitoring adverse events for submissions, preparation and review and generation of supporting documents for potential field alerts and recalls.
- Maintenance of approvals, including the preparation of annual reports for US products.
- Assess and review documentation to ensure compliance with product licences.
- Undertake general regulatory activities that interface with other departments such as Manufacturing, Product Development, Quality Control and Quality Assurance.
- Actively participate in project teams, as required.

**Salary**: ₹174,993.78 - ₹897,934.39 per year

**Benefits**:

- Cell phone reimbursement
- Internet reimbursement
- Work from home

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus

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