Regulatory Compliance Associate (Generic Pharma)

Regulatory Compliance Associate role at Granules Consumer Health LLC, a subsidiary of Granules India LTD, responsible for global labeling requirements, labeling strategy, and regulatory compliance.

Requirements

• Subject matter expert (SME) for global labeling requirements for OTC and ANDA Products
• Establish labeling strategy and requirements for customer labels
• Responsible for Drug listing of Granules USA marketed products
• Review and approves product labeling and maintain labeling database
• Assists in leading regulatory training on labeling requirements
• Approves labeling to ensure compliance with corporate, regulatory, safety and legal requirements
• Initiates change control to ensure regulatory assessments are identified, documented and implemented
• Responsible for coordinating regulatory submissions for ANDA products
• Reviewing and approving artwork files on various customer artwork portals
• Providing support to QA as needed
• Prepare and maintain the internal Regulatory Databases