Sr.Officer/ Executive

Drlogy; Mumbai; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Drlogy in Mumbai is hiring a Sr. Officer / Executive responsible for authoring and reviewing Chemistry, Manufacturing, and Controls (CMC) documentation for ANDA submissions and post-approval changes. The candidate will coordinate with various stakeholders ensuring timely preparation and compliance with FDA guidelines. The role includes managing eCTD submissions, maintaining documentation accuracy, and supporting regulatory activities. Ideal candidates should have strong experience in regulatory documentation and excellent communication skills.

Qualifications

• Experience in preparing, compiling and reviewing regulatory documentation for ANDA submissions.
• Strong understanding of FDA guidelines and regulatory compliance.
• Ability to coordinate across multiple departments for document collection.

Responsibilities

• Compile and review CMC documentation for ANDA filings.
• Coordinate with stakeholders to ensure timely availability of regulatory documents.
• Support lifecycle management activities including amendments and supplements.

Job description

The Sr. Officer / Executive will be responsible for authoring, compiling, and reviewing CMC (Chemistry, Manufacturing, and Controls) documentation for ANDA submissions and post-approval changes. The involves coordinating with cross-functional stakeholders to collect required documents, ensuring regulatory compliance with FDA guidelines, and managing eCTD submission activities. The candidate will play a key in maintaining documentation accuracy, regulatory alignment, and timely submission of dossiers.

Responsibilities

• Author, compile, and review CMC documentation for ANDA filings and post-approval submissions.
• Prepare and organize regulatory dossiers in alignment with FDA requirements and guidelines.
• Coordinate with R&D, QA, QC, production, analytical, and other stakeholders to collect required documents.
• Ensure timely availability of all regulatory documents as per project timelines.
• Review technical documents to ensure compliance with FDA guidances and regulatory standards.
• Maintain accuracy, consistency, and completeness of regulatory submission content.
• Prepare and manage eCTD submissions using regulatory publishing tools and software.
• Support lifecycle management activities including amendments, supplements, and variations.
• Track project timelines and ensure timely completion of regulatory deliverables.
• Maintain regulatory documentation records and ensure proper version control.
• Stay updated with FDA regulations, guidelines, and global regulatory requirements.
• Support gap analysis of documentation and ensure corrective actions for compliance.
• Coordinate with internal teams and external stakeholders for query resolution and data collection.
• Assist in responding to regulatory authority queries and deficiency letters.
• Ensure data integrity, accuracy, and compliance across all regulatory submissions.
• Support audit and inspection readiness activities related to regulatory documentation.
• Contribute to process improvements in regulatory documentation and submission workflows.
• Prepare status reports and updates for management review.
• Maintain confidentiality of regulatory and product-related information.