Senior Executive DRA

Drlogy; Ahmedabad District; On-site; INR 600,000 - 800,000; Full time

Job summary

Drlogy in Ahmedabad is seeking a Senior Executive DRA to manage drug regulatory affairs documentation and support product registration. The ideal candidate should have a graduate or post graduate qualification along with 6–8 years of experience in DRA, QA documentation, and regulatory affairs.

This role involves preparing regulatory dossiers, coordination with multiple departments, maintaining compliance, and responding to regulatory queries. Join Drlogy to contribute to drug registration support and compliance activities in a dynamic environment.

Qualifications

• 6–8 years of experience in DRA, QA documentation, and regulatory affairs.
• Strong understanding of regulatory requirements.
• Proven ability to manage regulatory documentation and submissions.

Responsibilities

• Prepare and review regulatory dossiers and technical documents.
• Coordinate product registration and compliance documentation.
• Maintain accurate DRA trackers and submission records.
• Support audits, inspections, and responses to regulatory queries.

Skills

DRA management

QA documentation

Regulatory affairs

Compliance tracking

Dossier preparation

Education

Graduate or Post Graduate qualification

Job description

The Senior Executive DRA will manage drug regulatory affairs documentation, dossier preparation, QA documentation coordination, product registration support, compliance tracking, and regulatory submission activities at Helios, Ahmedabad. This requires graduate or post graduate qualification with 6–8 years of DRA, QA documentation, and regulatory affairs experience.

Responsibilities

• Prepare and review regulatory dossiers, technical documents, product registration files, and submission packages.
• Coordinate product registration, renewal, variation, amendment, and regulatory compliance documentation.
• Review QA documentation, specifications, stability data, validation documents, and batch‑related technical records.
• Coordinate with QA, QC, production, packaging, R&D, warehouse, and management teams for regulatory data.
• Maintain DRA trackers, submission records, approval files, query responses, and compliance documents.
• Review documents for completeness, accuracy, data integrity, and regulatory alignment.
• Support response preparation for regulatory queries, customer requirements, and audit observations.
• Track regulatory timelines, pending documents, product approvals, and compliance updates.
• Maintain confidentiality of product, technical, and regulatory information.
• Support audits, inspections, customer queries, and regulatory readiness activities.
• Follow approved SOPs, regulatory requirements, and quality standards.
• Ensure timely, accurate, and compliant drug regulatory affairs support.