Regulatory Affairs Executive

Ami Lifesciences Pvt. Ltd.; Vadodara; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Ami Lifesciences Pvt. Ltd. in Vadodara is seeking an experienced Regulatory Affairs professional to lead CTD dossier preparation for European markets and ensure DMF compliance.

You will coordinate with cross-functional teams to ensure timely submissions and maintain meticulous records of all regulatory submissions and correspondence, supporting API manufacturing processes.

Qualifications

• 4-10 years of experience in Regulatory Affairs in the pharmaceutical industry.
• Strong knowledge of CTD format for dossier preparation.
• Experience working on bulk drugs regulations in Europe (DMF).
• Familiarity with API manufacturing processes.

Responsibilities

• Prepare and submit CTD dossiers for bulk drug products to European regulatory authorities.
• Ensure DMF compliance for API manufacturing facilities.
• Coordinate with cross-functional teams to ensure timely regulatory submissions.
• Maintain records of all regulatory submissions and correspondence.

Skills

Regulatory affairs

CTD format

DMF knowledge

Cross-functional coordination

Documentation control

Job description

Roles and Responsibilities :

• Prepare and submit dossiers (CTD) for bulk drug products to European regulatory authorities.
• Ensure compliance with DMF requirements for API manufacturing facilities.
• Coordinate with cross-functional teams to ensure timely submission of regulatory documents.
• Maintain accurate records of all regulatory submissions and correspondence.

Job Requirements :

• 4-10 years of experience in Regulatory Affairs in the pharmaceutical industry.
• Strong knowledge of CTD format for dossier preparation.
• Experience working on bulk drugs regulations in Europe (DMF).
• Familiarity with API manufacturing processes.