AP
Hiring companyAzurity Pharmaceuticals - India
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Deputy Manager/Manager - Regulatory Affairs
Hyderabad, IN Full-time On-site
About the role
Azurity Pharmaceuticals seeks a Deputy Manager or Manager to lead global regulatory strategies for its specialty pharmaceutical portfolio. Based in Hyderabad, this hybrid role involves managing submissions to agencies like the FDA and EMA while overseeing lifecycle maintenance. The position requires driving end-to-end approval processes across US, EU, UK, and Canadian markets.
What you’ll do
- Drive end-to-end regulatory strategies for product registration and approval across US, EU, UK, Canada markets
- Oversee preparation, review, and filing of regulatory dossiers including NDAs, NDSs, and MAAs
- Lead cross-functional team discussions to align submission strategies and establish timelines
- Perform global regulatory due diligence and gap assessments to identify risks
- Manage regulatory readiness for launch in compliance with evolving EU and UK regulations
- Direct post-approval regulatory activities including supplements, variations, and renewals
- Monitor region-specific regulations and provide strategic guidance to cross-functional teams
- Support assessment of promotional materials to ensure regulatory compliance
What you’ll bring
- 8+ years of experience in pharmaceutical regulatory affairs for US, EU, UK, Canada markets
- Master of Science in Pharmaceuticals or Equivalent
Skills
Regulatory strategiesProduct registrationSubmission managementGap assessmentsRegulatory readinessPost-approval activitiesCross-functional leadershipHealth authority communication
Education
Master of Science in Pharmaceuticals or Equivalent