Job Title: Junior Manager, Regulatory Affairs
Location: MDPL-TC, Gummadidala
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Salary: Not Disclosed
Experience: 5 – 8 years
Job Description:
- Compile and submit DMF to regulatory authorities.
- Address and submit responses to deficiencies within specified time frames.
- Lead cross-functional team (CFT) meetings for deficiency-related activities.
- Respond promptly to customer queries.
- Evaluate and manage change controls as per regulatory variation guidelines.
- Oversee lifecycle management for regulatory submissions.
- Maintain regulatory submission databases.
- Proficient in eCTD submission software.