Ensuring Compliance Guaranteeing that drug development manufacturing and marketing align with national and international regulatory guidelines and industry standards Regulatory Submissions Preparing reviewing and submitting comprehensive dossiers and applications e g New Drug Applications NDAs Investigational New Drugs INDs to regulatory agencies like the FDA or EMA Documentation Management Overseeing the creation and maintenance of critical documents including clinical trial protocols product labels and promotional materials Liaising with Regulatory Agencies Serving as the primary point of contact and communication between the company and health authorities addressing concerns and facilitating approvals Interpreting Regulations Providing expert guidance on the interpretation and application of evolving regulations and guidelines to internal project teams and management Labeling and Advertising Review Ensuring that drug labels package inserts and marketing materials are accurate compliant and provide necessary information on use dosage and side effects Clinical Trial Support Collaborating with clinical research teams to ensure that clinical trials are conducted according to Good Clinical Practice GCP and meet regulatory requirements Post-Market Surveillance Assisting with ongoing compliance activities such as submitting periodic safety update reports PSURs and managing post-marketing surveillance data Skills and Qualifications Analytical Skills Ability to interpret complex regulations and scientific data Communication Skills Clear and effective communication to liaise with various departments senior management and regulatory agencies Attention to Detail Meticulousness in preparing precise and compliant documentation Knowledge of Guidelines Understanding of key regulatory guidelines such as Good Manufacturing Practice GMP Good Clinical Practice GCP and Common Technical Job Types Full-time Permanent Pay 25 000 00 - 35 000 00 per month Advantages Food provided Health insurance Paid time off Work Location In person

📌 Drug Regulatory Affairs (Kathua)
🏢 Sanctus Global Formulations
📍 Kathua