International Regulatory Affairs Executive
7 days ago
**JOB PROFILE**
POSITION:_**EXECUTIVE - INTERNATIONAL REGULATORY AFFAIRS**_
OFFICE TIME: 9:30 AM to 6:30 PM (Monday to Friday)
On Saturday’s (i.e. 1st / 3rd, 5th Working till 04:00 PM)
On Saturday (i.e. 02nd & 4th having off)
LOCATION: Makarba, SG Highway, Ahmedabad
QUALIFICATIONS: B-Pharm / M-Pharm
EXPERIENCE: Minimum: 01 to 02 Years
- Preparing, Reviewing and Submitting - Product Dossiers as per Country Specific guidelines
- Preparing, Reviewing and Submitting - Renewal Dossiers / Variations.
- Responding to queries raised by Regulatory authority of respective country.
- Preparing CAPA reports for the audit or market complaints.
- Coordinating with various department for Technical Documents as DMF, Stability data, FP COA, API COA, etc.
- Coordinating & Arranging for the registration samples as per country guideline.
- Reviewing & Approving the Artworks (Text Content)
- Coordinating with FDCA Person for COPP & GMP and its legalization process.
- Updating all registration status records.
- Maintaining Retain Samples Records.
- Coordinating with customer for filing of dossier & getting it timely approval.
Fluent in English.
Good communication skills.
Ability to work under pressure and to meet deadlines.
Pay: ₹25,000.00 - ₹35,000.00 per month
**Benefits**:
- Cell phone reimbursement
- Paid sick time
- Paid time off
Supplemental Pay:
- Yearly bonus
Application Question(s):
- Are you from Pharma Industry ?
- Have you done B Pharm or M Pharm ?
**Language**:
- English (preferred)
Work Location: In person
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