Asst. Manager/ Sr.Exexcutive

Drlogy; Mumbai; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Drlogy is seeking an Assistant Manager / Sr. Executive in Regulatory Affairs to oversee assigned regulatory projects in Mumbai, Maharashtra. This role demands managing CMC documentation for ANDA filings, coordinating with cross-functional stakeholders, and ensuring regulatory compliance with FDA guidelines. The ideal candidate will ensure high-quality dossier submissions and support regulatory operations. Strong background in regulatory compliance and documentation management is essential for this position.

Qualifications

• Experience in handling regulatory projects in a pharmaceutical or biotech setting.
• Strong understanding of regulatory guidelines and compliance requirements.
• Proven skills in documentation management and lifecycle management.

Responsibilities

• Manage assigned regulatory projects and ensure timely completion.
• Author and compile CMC documentation for ANDA filings.
• Coordinate with stakeholders to ensure compliance and documentation quality.

Skills

Regulatory compliance

CMC documentation

Cross-functional coordination

Regulatory documentation management

Knowledge of FDA guidelines

Tools

eCTD submission systems

Job description

The Assistant Manager / Sr. Executive – Regulatory Affairs will be responsible for handling assigned regulatory projects within defined timelines, including CMC documentation for ANDA filings and post-approval submissions. The involves coordinating with cross-functional stakeholders, ensuring regulatory compliance with FDA guidelines, managing documentation systems, and maintaining regulatory history and traceability. The candidate will play a key in ensuring smooth regulatory operations and timely submission of high-quality dossiers.

• Manage assigned regulatory projects and ensure timely completion of all deliverables.
• Author, review, and compile CMC documentation for ANDA filings and post-approval submissions.
• Coordinate with R&D, QA, QC, production, analytical, packaging, and other stakeholders to collect required documentation.
• Ensure adherence to project timelines and regulatory submission schedules.
• Review technical documents against FDA guidelines to ensure regulatory compliance.
• Maintain up-to-date knowledge of global regulatory guidelines, requirements, and updates.
• Manage regulatory documentation lifecycle including filing, tracking, archiving, and retrieval systems.
• Ensure proper traceability and control of regulatory history across all submissions.
• Support preparation and maintenance of eCTD dossiers and submission-ready documentation.
• Identify gaps in documentation and ensure timely resolution for compliance readiness.
• Coordinate responses to regulatory authority queries and deficiency letters.
• Ensure accuracy, consistency, and completeness of all regulatory documents.
• Maintain regulatory databases and documentation management systems efficiently.
• Support internal audits, inspections, and compliance assessments.
• Ensure data integrity and adherence to SOPs, company policies, and regulatory standards.
• Prepare status reports and project updates for management review.
• Contribute to process improvements in regulatory operations and documentation systems.
• Support lifecycle management of regulated products including amendments and variations.
• Maintain confidentiality of regulatory and product-related information at all times.