International Regulatory Affairs Executive

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