Regulatory Affairs Officer

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: - ( - )

Experience: 4+ yrs

Location: Bengaluru

Job Type: Full-time

We are looking for an experienced and detail-oriented professional to contribute to operations within a pharmaceutical manufacturing environment. The role is suited for someone who understands regulated pharmaceutical operations and can work effectively within established quality, compliance, and manufacturing standards.

The ideal candidate should be familiar with pharmaceutical formulations and manufacturing processes across multiple dosage forms, with a strong commitment to quality, regulatory compliance, operational discipline, and continuous improvement.

Requirements

Key Responsibilities

• Support day-to-day activities within the pharmaceutical manufacturing and operations environment.
• Ensure manufacturing activities are carried out in accordance with approved SOPs, GMP requirements, and quality standards.
• Coordinate with production, quality assurance, quality control, engineering, warehouse, and other relevant teams.
• Monitor operational processes to ensure consistency, efficiency, and compliance.
• Maintain accurate documentation, records, batch-related information, and operational reports.
• Identify process deviations, operational issues, and quality concerns and escalate them through appropriate channels.
• Support investigations, corrective actions, and preventive actions where required.
• Ensure proper handling of materials, equipment, processes, and documentation in accordance with established procedures.
• Contribute to maintaining a clean, safe, organised, and compliant manufacturing environment.
• Support internal and external audits, inspections, and compliance activities as required.
• Assist in identifying opportunities for process improvement, operational efficiency, and quality enhancement.
• Maintain effective communication with cross-functional teams to ensure smooth and timely execution of activities.
• Follow all applicable safety, quality, regulatory, and environmental requirements.
• Contribute to continuous improvement initiatives within the manufacturing operation.

What Makes You a Great Fit

• 4+ years of relevant experience in pharmaceutical manufacturing, production, operations, or a related function.
• Good understanding of pharmaceutical manufacturing processes and GMP practices.
• Exposure to multiple pharmaceutical dosage forms such as tablets, capsules, liquids, dry syrups, topicals, ophthalmic products, or injectables is an advantage.
• Strong understanding of WHO-GMP principles, SOPs, documentation, and quality compliance.
• Ability to work effectively with production, QA, QC, engineering, warehouse, and other cross-functional teams.
• Strong attention to detail and commitment to maintaining high standards of product quality and compliance.
• Good problem-solving and analytical skills with a proactive approach to identifying operational issues.
• Strong documentation and reporting skills.
• Ability to work in a regulated, process-driven, and quality-focused environment.
• Good communication and coordination skills.
• Comfortable working with established procedures while contributing ideas for process improvement and operational efficiency.
• Strong sense of accountability, discipline, and ownership of assigned responsibilities.