Cipla Pharma Vacancies – Apply Online
Team Member – Regulatory Respiratory
Posting Date: 21 Jan 2025
Country: India
State: Maharashtra
Location: Vikhroli
Req Id: 89208
Division: IPD
Department: IPD
Employment Type: Permanent
Job Purpose
Prepare, review, modify, collate, and submit documents for product registrations and maintain the life cycle of respiratory products, update regulatory database, support launches, and ongoing commercials to meet the objectives of the 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 coordination 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.
VI. Support portfolio initiatives, e.g., identifying leverage
VII. Participate in Control Tower, SAP, CIPDOX, GOOSE meetings on behalf of the respiratory team.
Education Qualification: Bachelor’s/Master’s degree in Pharmacy.
Relevant Work Experience: 6 years’ 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
Apply Online: APPLY ONLINE HERE
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