Team Member – Regulatory Respiratory | Cipla | Vikhroli

Job Purpose

Prepare, review, modify, collate, and submit documents for product registrations and maintain the life cycle of respiratory products, update the regulatory database, and support launches, and ongoing commercials to meet the objectives of regulatory affairs sub-function

Accountabilities

• Check region-wise regulatory requirements, perform gap analysis for registered dossiers, compile/recommend a regulatory strategy for product submission to check leveragability, and support development activities
• Compile respiratory product dossiers by collating and reviewing relevant registration information, submit dossiers as applicable, and compile deficiency responses to facilitate timely approvals of respiratory products globally
• Support on-time launches and ongoing commercials of respiratory products and devices identified by the business plan through cross-functional coordination and review of documents to ensure launch within the timeline
• Update and provide the regulatory status of respiratory products for the maintenance of the global registration database
• Manage post-approval life cycle management by contributing to the closure of change controls, by compiling and submitting regulatory packages, relevant to life cycle management to
• Support portfolio initiatives eg. identifying leverage products by evaluation of data, compliance with respect to site transfer initiatives to
• Participating in Control Tower, SAP, CIPDOX, and GOOSE, meetings on behalf of the respiratory team

Education Qualification

Bachelor’s / Master’s degree in Pharmacy

Relevant Work Experience

6 years experience in a regulatory filing (compilation, submission, and approval) with knowledge of drug product development and respiratory products (for US/EU/International markets)