Alembic Pharmaceuticals – Hiring Executive (Regulatory Affairs – API)

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.

Position: Executive – Regulatory Affairs (API)
Experience: 3 to 6 Years
Location: Corporate Office, Vadodara, Gujarat

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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

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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