Officer - RA

The Officer – RA will be responsible for preparing and managing regulatory documentation, coordinating submissions, and ensuring compliance with applicable regulatory requirements. The involves working closely with cross-functional teams to support product registrations, variations, renewals, and regulatory approvals. The candidate will monitor regulatory updates, maintain documentation accuracy, and ensure timely execution of regulatory activities in line with organizational and market requirements.

Roles & Responsibilities:

• Prepare, review, and compile regulatory dossiers and submission documents.
• Coordinate product registrations, renewals, variations, and approvals.
• Ensure compliance with regulatory requirements and applicable guidelines.
• Maintain regulatory documentation, records, and submission databases accurately.
• Coordinate with QA, QC, R&D, production, and other departments for regulatory inputs.
• Review technical documents for completeness, accuracy, and compliance.
• Track submission timelines and ensure timely responses to regulatory authorities.
• Handle regulatory queries, deficiency letters, and follow-up communications.
• Support preparation of CTD/eCTD dossiers and related documentation.
• Monitor changes in regulatory guidelines and assess their business impact.
• Ensure compliance of labeling, packaging, and artwork with regulatory standards.
• Assist in audit and inspection readiness related to regulatory documentation.
• Maintain product registration status and regulatory tracking reports.
• Coordinate with international agents, distributors, and regulatory authorities when required.
• Support lifecycle management activities for existing products.
• Ensure proper document control and data integrity practices.
• Participate in cross-functional meetings related to regulatory projects.
• Prepare MIS reports and status updates for management review.
• Support new product launches with regulatory compliance activities.
• Stay updated with pharmaceutical regulatory trends and industry best practices.

Mangalam Drugs & Organics Ltd is a pharmaceutical manufacturing company engaged in the production of Active Pharmaceutical Ingredients (APIs), intermediates, and finished dosages.

The company is committed to delivering high-quality pharmaceutical products while maintaining strong standards of safety, innovation, and regulatory compliance.

Our Story

Mangalam Drugs & Organics Ltd was established with the objective of contributing to the pharmaceutical industry through quality manufacturing and reliable healthcare solutions.

Over the years, the company has expanded its capabilities and built a strong presence in domestic and international markets through its focus on operational excellence and customer trust.

Our Mission

The company is committed to:

• Manufacturing high-quality pharmaceutical products and APIs
• Maintaining strict quality and regulatory standards
• Delivering reliable and affordable healthcare solutions
• Continuously improving operational efficiency and product innovation
• Building long-term relationships with customers and stakeholders

Our Vision

To be a globally recognized pharmaceutical company known for quality manufacturing, innovation, and excellence in healthcare solutions.

Our Services / What We Offer

Mangalam Drugs & Organics Ltd offers a diverse range of pharmaceutical products and manufacturing solutions, including:

• Manufacturing of Active Pharmaceutical Ingredients (APIs)
• Production of pharmaceutical intermediates
• Finished dosage formulations
• Quality assurance and regulatory-compliant manufacturing
• Export-focused pharmaceutical solutions

Why Choose Us

The company stands out for its commitment to pharmaceutical excellence:

• Strong expertise in API and pharmaceutical manufacturing
• Focus on quality, safety, and compliance
• Presence in domestic and international markets
• Modern manufacturing systems and infrastructure
• Commitment to continuous improvement and innovation

Our Team

Mangalam Drugs & Organics Ltd is supported by a team of experienced professionals dedicated to maintaining high standards in production, quality control, and operations.

Their expertise drives the company’s focus on efficiency, innovation, and customer satisfaction.

Infrastructure / Technology

The company utilizes advanced manufacturing facilities and modern technologies to ensure efficient production and consistent product quality.

Its infrastructure is designed to comply with industry regulations and support large-scale pharmaceutical manufacturing operations.

Our Commitment

Mangalam Drugs & Organics Ltd remains committed to delivering safe, effective, and high-quality pharmaceutical products while maintaining ethical business practices and regulatory compliance.

The company continuously works towards innovation, operational excellence, and improving healthcare accessibility.