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Alembic Pharmaceuticals is a leading pharmaceutical company headquartered in Vadodara, Gujarat, with a strong global presence. With over a century of expertise, Alembic focuses on research, development, manufacturing, and marketing of high-quality generic pharmaceuticals and APIs. The company is committed to innovation, regulatory excellence, and delivering affordable healthcare solutions worldwide.
Latest Jobs
Position: Executive – Regulatory Affairs (API)
Experience: 3 to 6 Years
Location: Corporate Office, Vadodara, Gujarat
Key Responsibilities:
- Compilation and review of DMF/CEP
- Preparation and submission of DMFs
- Responding to deficiencies from regulatory authorities and customers
- Reviewing compendial monographs for updates and compliance
- Reviewing Analytical Method Validations, Specifications of KSMs, Intermediates, and APIs for regulatory adequacy
- Managing customer communications effectively
- Issuing Letters of Access/Authorization (LOA) and regulatory declarations
- Preparing and submitting change notifications (prior and post approval)
- Tracking and monitoring regulatory filings, procedural changes, and updates from regulatory bodies
Alembic Pharmaceuticals is a trusted name in global pharma innovation and quality. If you have expertise in Regulatory Affairs (API) and are seeking a dynamic role, this is your opportunity.
Apply Now: Send your CV to creyesha.macwan@alembic.co.in
