Deputy Manager/Manager

Overview

Deputy Manager/Manager role in pharmaceutical regulatory affairs, focused on designing and executing global regulatory strategies for product approvals and lifecycle maintenance across multiple markets.

What you'll do

• Drive end-to-end regulatory strategies for product registration and approval across US, EU, UK, and Canada.
• Oversee preparation, review, and filing of regulatory dossiers including NDAs, NDSs, and MAAs.
• Lead cross-functional discussions to align submission strategies, priorities, and timelines.
• Conduct global regulatory due diligence and gap assessments to identify risks and mitigation strategies.
• Manage review and approval of artwork (including SPCs and PILs) to meet current standards.
• Handle regulatory readiness for launch and manage post-approval activities like supplements, variations, and renewals.

What you'll need

• 8+ years of experience in pharmaceutical regulatory affairs for US, EU, UK, and Canada markets.
• Master of Science in Pharmaceuticals or equivalent regulatory affairs exposure.
• Ability to perform under pressure with limited resources.
• Excellent communication and presentation skills in English.
• Strong writing, analytical, and problem-solving abilities.

Details

• Location: Hyderabad, IN.