Job Title: Junior Manager, Regulatory Affairs
Location: MDPL-TC, Gummadidala
Salary: Not Disclosed
Experience Required: 5 – 8 years
Job Description:
- Compile and Submit DMFs: Compile Drug Master Files (DMFs) and submit them to regulatory authorities.
- Respond to Deficiencies: Address and submit responses to deficiencies within specified time frames.
- Lead Cross-Functional Team (CFT) Meetings: Lead meetings focused on deficiency-related activities.
- Customer Queries: Respond promptly to customer queries.
- Change Controls: Evaluate and manage change controls as per regulatory variation guidelines.
- Lifecycle Management: Oversee lifecycle management for regulatory submissions.
- Submission Databases: Maintain regulatory submission databases.
- eCTD Submission Software: Proficient in using Electronic Common Technical Document (eCTD) submission software.
Responsibilities:
| Task | Description |
|---|---|
| Compile DMFs | Compile Drug Master Files and submit to regulatory authorities |
| Respond to Deficiencies | Address deficiencies and submit responses within specified time frames |
| Lead CFT Meetings | Lead cross-functional team meetings focused on deficiency-related activities |
| Customer Queries | Respond promptly to customer queries |
| Change Controls | Evaluate and manage change controls as per regulatory variation guidelines |
| Lifecycle Management | Oversee lifecycle management for regulatory submissions |
| Submission Databases | Maintain accurate regulatory submission databases |
| eCTD Software | Proficient in using eCTD submission software |
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Meta Description: Junior Manager, Regulatory Affairs position at Maithri Drugs, Gummadidala. 5-8 years of experience required.