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Are you a Regulatory Affairs or Quality Assurance professional with 5+ years of experience? Do you want to work in a dynamic environment at Vikhroli, Maharashtra? We are hiring a Team Member – CDT to join our IPD (International Product Development) division. This is a permanent position with a focus on regulatory compliance, dossier compilation, and product evaluation for international markets.
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Job Purpose
As a Team Member – CDT, you will be responsible for:
- Compiling dossiers in line with regulatory strategies.
- Managing deficiencies and ensuring adherence to regulatory requirements.
- Evaluating products and submitting tenders for international markets.
- Ensuring all tasks are completed within agreed timelines.
Key Accountabilities
- Dossier Compilation: Review and compile high-quality dossiers as per regulatory guidelines to minimize deficiencies from health authorities.
- Deficiency Management: Evaluate and respond to quality deficiencies for all regions to meet health authority timelines.
- Product Evaluation: Assess and submit product evaluation and tender documents for DRF conversion and commercialization.
- Regulatory Updates: Stay updated on new regulatory guidelines and train regional teams to reduce deficiencies.
Education and Experience
- Education: Graduate/Post Graduate in Pharmacy or Life Sciences.
- Experience: Minimum 5 years in Regulatory Affairs or Quality Assurance.
Required Competencies and Skills
- Collaborate to Succeed
- Innovate to Excel
- Perform with Accountability
- Lead with Empathy
- Act with Agility
- Strong Domain Knowledge
- People Management
Job Location and Shift Hours
- Location: Vikhroli, Maharashtra, India
- Shift Hours: Standard office hours (details to be discussed during the hiring process).
Why Join Us?
- Be part of a globally recognized organization in the pharmaceutical industry.
- Work in a collaborative and innovative environment.
- Opportunities for professional growth and development.
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