Team Member – Regulatory Respiratory
Job Purpose
Prepare, review, ,modify, collate, submit documents for product registrations and maintain life cycle of respiratory products, update regulatory database, support launches and ongoing commercials to meet the objectives of regulatory affairs sub-function
Accountabilities
I. Check region-wise regulatory requirements, perform gap analysis for registered dossiers, compile/recommend regulatory strategy for product submission to check leveragability, and to support development activities
II. Compile respiratory product dossiers by collating and reviewing relevant registration information, submit dossiers as applicable, compile deficiency responses to facilitate timely approvals of respiratory products globally
III. Support on-time launches and ongoing commercials of respiratory products and devices identified by the business plan through cross functional co-ordination and review of documents to ensure launch within timeline
IV. Update and provide the regulatory status of respiratory products for maintenance of the global registration database
V. 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
VI. Support portfolio initiatives eg. identifying leverage products by evaluation of data, compliance with respect to site transfer initiatives to
VII. Participating in Control Tower, SAP, CIPDOX, GOOSE, meetings on behalf of respiratory team
Education Qualification
Bachelor’s / Master’s degree in Pharmacy
Relevant Work Experience
6yearsâ experience in regulatory filing (compilation, submission and approval) with knowledge of drug product development and respiratory products (for US/EU/International markets)
Competencies/Skills
Collaborate to Succeed
Innovate to Excel
Perform with Accountability
Lead with Empathy
Act with Agility
Strong Domain Knowledge
People Management
Job Location
Vikhroli