Cadila Pharma Hiering for Regulatory Affairs Specialist

Cadila Pharma Hiering for Regulatory Affairs

Location: Dholka, Gujarat
Experience: Minimum 7 years
Education: M.Pharm
Application Method: Email your resume to disha.bhalani@cadilapharma.com

About Cadila Pharmaceuticals

Cadila Pharmaceuticals is a leading pharmaceutical company with a legacy of innovation and excellence. Join a dynamic team that shapes global healthcare standards in a supportive and growth-oriented environment. Cadila Pharma Hiering for Regulatory Affairs

Position Overview

• Role: Regulatory Affairs Specialist
• Qualification: M.Pharm
• Experience: Minimum of 7 years in regulatory affairs
• Location: Dholka, Gujarat

Key Responsibilities

• Dossier Compilation: Compile, review, and submit registration dossiers for the US market.
• Regulatory Query Management: Address and resolve regulatory queries and deficiencies effectively.
• Post-Approval Activities:
  • Manage Annual Reports and post-approval supplements (CBE-0, CBE-30, PAS).
  • Handle post-approval submissions using eCTD software for ANDA/IND.
• Document Review: Approve and review functional documents such as:
  • Specifications and test procedures
  • Product development reports
  • Stability protocols
  • Process validation reports
  • Batch manufacturing and packaging records
• Regulatory Evaluation:
  • Assess analytical method validation, verification, and transfer reports.
  • Review DMF documents and related notifications.
• Change Control & Deviations: Approve and monitor change controls and deviations.
• Regulatory Database Maintenance: Maintain and update databases for all submissions.
• Training: Conduct training sessions on new regulatory guidelines for the team.

Why Join Cadila Pharmaceuticals?

• Work with a reputed pharmaceutical leader known for innovation.
• Be part of projects that impact global healthcare standards.
• Enjoy a supportive and dynamic work environment.
• Enhance your expertise in regulatory affairs and grow your career.

How to Apply

If you are a skilled professional with a passion for regulatory affairs, share your updated resume with us at disha.bhalani@cadilapharma.com to explore this exciting opportunity.

Join Cadila Pharmaceuticals and make a difference in global healthcare! Cadila Pharma Hiering for Regulatory Affairs

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