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