Manager-Regulatory & Business Continuity - US Market

As a Regulatory Submission Specialist, your role involves handling the regulatory submission of new products, variations, and responses to queries for the US and OAM regions. Your primary responsibility is to prepare quality dossiers to ensure timely approvals for life cycle management. Key Responsibilities: - Review and prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. - Review various documents such as Development reports, scale-up reports, specifications, stability protocols, and analytical validations before initiating Exhibit batches. - Prepare responses to deficiencies to facilitate the approval of products filed with regulatory agencies. - Manage the life cycle of drug formulations by preparing and reviewing variations, annual notifications, and labeling approvals for the US and OAM regions. - Review change control procedures and file variations as per country requirements. - Compile eCTD submissions and ensure the repository contains comprehensive product information. - Evaluate the regulatory filing impact of variations, change controls, and other regulatory compliance matters. Qualifications Required: - Bachelor's degree in a relevant field (e.g., Pharmacy, Chemistry, Regulatory Affairs). - Prior experience in regulatory submissions and life cycle management within the pharmaceutical industry. - Strong understanding of CMC requirements and eCTD compilation processes. - Excellent attention to detail and organizational skills to manage multiple submissions effectively. This job involves critical responsibilities in ensuring regulatory compliance and timely approvals for new products and variations. Your expertise in preparing quality dossiers and managing regulatory submissions will play a crucial role in the success of the company.,