Deputy Manager/Manager

The role

The person will lead end-to-end regulatory strategies for pharmaceutical products across US, EU, UK, and Canada markets. They will manage submissions, oversee dossier preparation, and lead cross-functional team discussions to ensure compliance and timely approvals.

What you will do

• Drive end-to-end regulatory strategies for product registration and approval across US, EU, UK, Canada markets.
• Oversee the end-to-end preparation, review, and filing of regulatory dossiers.
• Lead cross-functional team discussions to align submission strategies and timelines.
• Perform global regulatory due diligence and gap assessments for US, EU, UK, and Canada filings.
• Manage the review and approval of artwork including SPCs and PILs.
• Manage regulatory readiness for launch in compliance with EU and UK regulations.
• Handle activities related to xEVMPD, RIMS, PLM, IRIS, etc.
• Support the assessment of promotional materials for regulatory compliance.
• Direct post-approval regulatory activities including supplements, variations, and renewals.
• Monitor evolving region-specific regulations and provide strategic guidance.

Required qualifications

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

Nice to have

• Regulatory Affairs exposure to China and Emerging markets

About the company

Azurity Pharmaceuticals is a company that repurposes proven molecules and reimagines how therapies are designed, delivered, and accessed. Their portfolio includes more than 70 medicines across 11 therapeutic areas reaching more than 50 countries.