International Regulatory Affairs Executive

4 days ago


Gota Ahmedabad Gujarat, India Surety Healthcare LLP Full time

JOB PROFILE POSITION: EXECUTIVE - INTERNATIONAL REGULATORY AFFAIRS LOCATION: Gota, SG Highway, Ahmedabad

QUALIFICATIONS: B-Pharm / M-Pharm

EXPERIENCE: Minimum: 01 to 02 Years RESPONSIBILITIES:

- 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.

SKILLS:
Fluent in English.

Good communication skills.

Ability to work under pressure and to meet deadlines.

**Job Types**: Full-time, Permanent

Pay: ₹12,155.03 - ₹49,054.27 per month

**Benefits**:

- Paid sick time
- Paid time off

Work Location: In person



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