RA Executive

Drlogy; India; On-site; INR 300,000 - 500,000; Full time

Job summary

Drlogy in India is looking for a detail-oriented RA Executive who will manage regulatory affairs activities and prepare submission documents. The successful candidate will ensure compliance with pharmaceutical regulatory standards and coordinate closely with QA, QC, and production teams.

The role requires experience in dossier preparation, product registration, and maintaining regulatory documentation. Strong coordination with regulatory authorities and external agencies is essential to facilitate product approvals and ensure operational compliance.

Qualifications

• Detail-oriented with experience in managing regulatory affairs activities.
• Skilled in dossier preparation and product registration.
• Able to coordinate with regulatory authorities and ensure compliance.

Responsibilities

• Prepare and compile regulatory submission documents accurately.
• Coordinate product registration and approval activities.
• Ensure compliance with pharmaceutical regulatory guidelines and standards.
• Maintain regulatory records and documentation systems effectively.
• Coordinate with QA, QC, and production teams for compliance requirements.
• Review product labeling and packaging documentation.
• Monitor changes in regulatory guidelines and industry requirements.
• Handle regulatory queries and support response preparation activities.
• Maintain submission timelines and approval tracking records.
• Support audits and regulatory inspection activities.
• Ensure proper filing and management of regulatory documentation.
• Assist in preparation of SOPs and compliance procedures.
• Coordinate with regulatory authorities and external agencies when required.
• Support process improvement and operational compliance initiatives.
• Maintain confidentiality of regulatory and product-related information.

Job description

Detail-oriented RA Executive responsible for managing regulatory affairs activities, preparing submission documents, and ensuring compliance with pharmaceutical regulatory standards. Skilled in dossier preparation, product registration, documentation management, and coordination with regulatory authorities. Experienced in supporting product approvals and maintaining compliance within pharmaceutical manufacturing operations.

• Prepare and compile regulatory submission documents accurately.
• Coordinate product registration and approval activities.
• Ensure compliance with pharmaceutical regulatory guidelines and standards.
• Maintain regulatory records and documentation systems effectively.
• Coordinate with QA, QC, and production teams for compliance requirements.
• Review product labeling and packaging documentation.
• Monitor changes in regulatory guidelines and industry requirements.
• Handle regulatory queries and support response preparation activities.
• Maintain submission timelines and approval tracking records.
• Support audits and regulatory inspection activities.
• Ensure proper filing and management of regulatory documentation.
• Assist in preparation of SOPs and compliance procedures.
• Coordinate with regulatory authorities and external agencies when required.
• Support process improvement and operational compliance initiatives.
• Maintain confidentiality of regulatory and product-related information.