Regulatory Affairs Archives

Project Manager – Regulatory Affairs

Job Summary: We are seeking an experienced and highly motivated Project Manager (Regulatory Affairs) to lead and manage regulatory projects from initiation to completion, ensuring timely and successful product registration, market authorization, and compliance with relevant regulatory requirements. The ideal candidate will have a deep understanding of global regulatory frameworks, exceptional project management skills, and […]

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Manager – Regulatory Affairs – EM

development

Job Descriptions CMC review of technical documentation for regulatory filings to various markets – market: US- Gap Analysis and Remediation for module 3 -CMC Development and implementation of regulatory strategies, processes and timelines for grant of MA- Africas, GCC, LATAM, ASEAN. Review of CTD dossiers , variations, change controls, renewals and ensuring that they are

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Assistant Manager – Regulatory Affairs – EU

development

Job Title: Assistant Manager – Regulatory Affairs (EU & UK) Location: Gurgaon, Haryana (India) Experience: 4–6 Years Qualification: Master’s Degree in Pharmacy (M.Pharm or equivalent) Role Overview We are seeking a proactive and detail-oriented Assistant Manager – Regulatory Affairs to join our Global Regulatory team. The ideal candidate will be responsible for driving CMC

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Assistant Manager – API_RA

development

Job Descriptions CMC review of technical documentation for regulatory filings to various markets – market: EU & UK, US- Gap Analysis and Remediation for module 3 -API Prepare and compile Section 322, QOS & QbR ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met. Critically reviews

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