Job Summary

Team is responsible for designing and executing global regulatory strategies to ensure the timely approval of a diverse portfolio of pharmaceutical products and the lifecycle maintenance of these products. The team works across multiple complex projects, facilitating various types of submissions to agencies like the FDA, EMA, MHRA or EU National Authorities, HC, and other international authorities, by ensuring compliance with evolving regulations.
Principal Responsibilities
- Drive end-to-end regulatory strategies for product registration and approval across US, EU, UK, Canada markets by managing the submissions including Pre-INDs, Scientific Advice (ScAs), Pediatric Investigation Plans (PIPs), and Notified Body Opinions etc.
- Oversee the end-to-end preparation, review, and filing of regulatory dossiers (NDAs, NDSs, and MAAs (CP, DCP, MRP, NPs) etc. to ensure timely submissions.
- Lead cross-functional team discussions to align submission strategies, define priorities, and establish realistic timelines based on evolving regulatory requirements.




- Perform global regulatory due diligence and comprehensive gap assessments to identify potential risks and mitigation strategies for US, EU, UK, and Canada filings.
- Manage the review and approval of artwork, including SPCs and PILs, ensuring adherence to current standards.
- Manage regulatory readiness for launch in compliance with evolving EU and UK regulations.
- Hands on experience in handling activities related to xEVMPD, RIMS, PLM, IRIS, etc.
- Support the assessment of promotional materials to ensure regulatory compliance, as needed.
- Direct post-approval regulatory activities, including supplements, variations, and renewals, to ensure continuous compliance throughout the product lifecycle, as needed.
- Monitor evolving, region-specific regulations and proactively provide strategic guidance to cross-functional teams to ensure compliance
Core Responsibilities
- Lead the development and execution of end-

📌 Deputy Manager/Manager (Hyderabad)
🏢 Azurity Pharmaceuticals
📍 Hyderabad