DRA Officer or Senior Officer

Drlogy; India; On-site; INR 600,000 - 900,000; Full time

Job summary

Drlogy is seeking a skilled DRA Officer / Senior Officer responsible for supporting regulatory affairs operations. The ideal candidate will prepare regulatory dossiers, manage submissions, and ensure compliance with pharmaceutical regulations while coordinating with cross-functional teams.

The position requires expertise in dossier preparation and regulatory documentation, with a focus on maintaining compliance and improving efficiency in regulatory operations.

Responsibilities

• Prepare regulatory dossiers and submission documentation accurately.
• Support product registration and regulatory approval activities.
• Ensure compliance with pharmaceutical regulatory standards and guidelines.
• Maintain records related to licenses and regulatory submissions.
• Coordinate with departments for submission-related documentation.
• Review labeling and packaging compliance requirements.
• Handle regulatory queries and support response preparation activities.
• Monitor regulatory timelines and submission schedules regularly.
• Maintain regulatory databases and documentation systems accurately.
• Support audits and inspection readiness activities.
• Track changes in regulatory guidelines and industry requirements.
• Coordinate with regulatory authorities when required.
• Ensure proper filing and management of compliance records.
• Support process improvement and regulatory efficiency initiatives.
• Follow SOPs and quality standards related to regulatory affairs operations.

Job description

Skilled DRA Officer / Senior Officer responsible for supporting regulatory affairs operations, preparing submission documents, and maintaining pharmaceutical compliance activities. Experienced in dossier preparation, product registration, regulatory documentation, and coordination with cross-functional teams to ensure compliance with pharmaceutical regulations.

Responsibilities

• Prepare regulatory dossiers and submission documentation accurately.
• Support product registration and regulatory approval activities.
• Ensure compliance with pharmaceutical regulatory standards and guidelines.
• Maintain records related to licenses and regulatory submissions.
• Coordinate with departments for submission-related documentation.
• Review labeling and packaging compliance requirements.
• Handle regulatory queries and support response preparation activities.
• Monitor regulatory timelines and submission schedules regularly.
• Maintain regulatory databases and documentation systems accurately.
• Support audits and inspection readiness activities.
• Track changes in regulatory guidelines and industry requirements.
• Coordinate with regulatory authorities when required.
• Ensure proper filing and management of compliance records.
• Support process improvement and regulatory efficiency initiatives.
• Follow SOPs and quality standards related to regulatory affairs operations.