Granules India Ltd is hiring M. Pharma/ M. Sc as a Regulatory Affairs Analyst – Apply Now

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Attention M. Pharma graduates! Granules India Ltd is seeking talented individuals to join our team as Regulatory Affairs Analysts. If you’re passionate about navigating the complex landscape of regulatory requirements in the pharmaceutical industry and ensuring compliance, this could be the perfect role for you. Take the next step in your career with Granules India Ltd and contribute to our mission of delivering innovative healthcare solutions globally. Apply now and seize this opportunity to make a meaningful impact in the world of pharmaceutical regulation.

Skills & Knowledge

• Candidates must have experience of working in a generic pharmaceutical company.
• Demonstrated interpersonal skills.
• Knowledge and application of ICH Guidelines, DMF, EDMF / GMPs, GLPs, and GCPs principles.

Purpose

Provide support as a team member of Regulatory affairs in supporting various works on DMF filings and Queries handling.

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Responsibilities

• Provide support for Compilation of dossiers (Drug master files) and submitting to various regulatory agencies.
• Preparation of dossiers as per USFDA, EDQM, ASMFs, Heath Canada, WHO and other regulatory agencies dossier requirements.
• Preparation of responses to queries received from customers and regulatory agencies.
• Experience in change controls evaluation.
• Preparation of DMF Amendments/CEP revisions/Other DMF updates to support life cycle management of product.
• Hands on exposure in pharma ready eCTD software handling for US, Europe and Canada markets requirements.
• Ensuring the PDF properties of Dossiers for uploading into pharma ready eCTD software based on regulatory market requirements for converting PDF document in to XML backbone. Further the complete dossier is zip filed and submitted in to ESG gateway of USFDA and CESP portal of EU agencies.
• Liaising with internal customers and stakeholders to ensure coordination of all projects.
• Provide support for continuous improvement in existing procedures/practices/compliance of department.
• Provide support in the overall management of the Regulatory affairs department and create a healthy environment of teamwork and empowerment, and promoting the values of creativity, integrity, excellence, perseverance, flexibility and respect.

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