Deputy Manager/Manager

About the role

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.

What you'll do

• Drive end-to-end regulatory strategies for product registration and approval across US, EU, UK, Canada markets by managing the submissions including Pre-INDs
• 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

What you need

• Regulatory affairs
• Due diligence
• Communication