Job Description

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