Manager/ Senior Manager - Regulatory Affairs

Why This Role Matters
The Manager/Senior Manager – Regulatory Affairs ensures that Azurity Pharmaceuticals’ global product portfolio complies with international regulations and achieves timely approvals. This role is critical in managing complex regulatory submissions, maintaining lifecycle compliance, and supporting strategic decisions that impact patient access to innovative therapies.

Job Description
Based in Hyderabad, this position is responsible for designing, implementing, and leading global regulatory strategies across multiple markets, including the US, EU, UK, and Canada. The role involves end-to-end management of regulatory submissions, oversight of lifecycle maintenance, and cross-functional collaboration to ensure compliance with evolving regulations.

Key Features of the Role
• Drive regulatory strategies for product registration and approval across US, EU, UK, and Canada markets.
• Manage submissions including Pre-INDs, Scientific Advice (ScAs), Pediatric Investigation Plans (PIPs), NDAs, NDSs, and MAAs (CP, DCP, MRP, NPs).
• Lead cross-functional team discussions to align submission strategies, define priorities, and establish realistic timelines.
• Conduct global regulatory due diligence and gap assessments to identify risks and mitigation strategies.
• Monitor region-specific regulations and provide strategic guidance to ensure compliance.
• Manage the review and approval of artwork, SPCs, and PILs in compliance with current standards.
• Ensure regulatory readiness for product launches and ongoing lifecycle maintenance.
• Handle activities related to xEVMPD, RIMS, PLM, IRIS, and other regulatory platforms.
• Support assessment of promotional materials for regulatory compliance.
• Direct post-approval activities, including supplements, variations, and renewals.

Responsibilities
• Lead development and execution of end-to-end regulatory strategies for global pharmaceutical products.
• Ensure successful submissions and manage communications with Health Authorities such as FDA, EMA, MHRA, HC, and other national agencies.
• Oversee lifecycle management activities to maintain regulatory compliance.
• Provide regulatory support across international territories and emerging markets.
• Collaborate with cross-functional teams including Medical Affairs, Clinical, Commercial, and Quality for regulatory alignment.

Required Qualifications
• Master of Science in Pharmaceuticals or equivalent degree
• 12+ years of experience in pharmaceutical regulatory affairs across US, EU, UK, and Canada markets
• Exposure to regulatory affairs in China and other emerging markets is a plus
• Strong analytical, problem-solving, and writing skills
• Excellent communication and presentation skills in English
• Ability to perform under pressure with limited resources

Educational Requirements
• Master’s degree in Pharmaceuticals or related scientific discipline

Experience and Skills
• Deep knowledge of global regulatory requirements and submission processes
• Hands-on experience with regulatory platforms such as xEVMPD, RIMS, PLM, IRIS
• Proven experience managing complex, multi-market regulatory submissions
• Ability to lead cross-functional teams and align regulatory strategies with business objectives
• Strong organizational and analytical skills for regulatory planning and execution
• Experience with post-approval regulatory activities, variations, and lifecycle maintenance

Salary Insights
• Compensation based on company standards and experience; discussed during recruitment

Company Overview
Azurity Pharmaceuticals is a privately held specialty pharmaceutical company providing innovative medicines to underserved patient populations. The organization operates across multiple therapeutic areas, focusing on high-quality, patient-centric products and fostering an inclusive, collaborative workplace.

FAQs
• Who can apply?
Candidates with extensive regulatory affairs experience in US, EU, UK, and Canada markets.
• Is this role office-based?
Yes, located in Hyderabad with cross-functional collaboration.
• What regulatory submissions are handled?
End-to-end submissions including Pre-INDs, ScAs, NDAs, NDSs, MAAs, and post-approval activities.
• Are international markets involved?
Yes, including US, EU, UK, Canada, and optionally emerging markets like China.

Application Tips
• Highlight experience in global regulatory submissions and lifecycle management.
• Demonstrate knowledge of US, EU, UK, Canada, and emerging market regulatory requirements.
• Provide examples of successfully executed multi-market regulatory strategies.
• Showcase leadership and cross-functional collaboration skills.
• Emphasize ability to perform under pressure and manage complex regulatory projects.