International Regulatory Affairs Executive

4 hours ago

Gota Ahmedabad Gujarat, India Surety Healthcare LLP Full time ₹ 3,00,000 - ₹ 6,00,000 per year

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, ₹49,054.27 per month

Benefits:

  • Paid sick time
  • Paid time off

Work Location: In person

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