Drug Regulatory Affairs

• 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

Benefits:

• Food provided
• Health insurance
• Paid time off

Work Location: In person