Senior Executive, Regulatory Affairs

Growth For Impact; Gujarat; On-site; INR 1,000,000 - 1,800,000; Full time

Job summary

Growth For Impact in India is seeking a Regulatory Affairs professional to compile, prepare, review, and submit high-quality US ANDA and EU marketing authorization applications, including original submissions and amendments, for MDI/DPI inhalation products in compliance with applicable regulatory requirements, internal procedures, and established timelines.

The role entails performing comprehensive regulatory evaluations of assigned drug products to ensure compliance with current US FDA, EU, and

Responsibilities

• Compile, prepare, review, and submit US ANDA and EU MA applications for MDI/DPI inhalation products.
• Perform regulatory evaluations to ensure compliance with FDA, EU, and other requirements.
• Provide regulatory CMC support to cross-functional teams and manage submission timelines.
• Assess master formula clearance, IIG clearance, device sameness, specs, stability, literature, and FDA guidance for submissions.
• Develop regulatory strategies from product initiation through R&D, stability studies, and submission.

Job description

ROLE

• Compile, prepare, review, and submit high-quality US ANDA and EU marketing authorization applications, including original submissions and amendments, for MDI/DPI inhalation products in compliance with applicable regulatory requirements, internal procedures, and established timelines.
• Perform comprehensive regulatory evaluations of assigned drug products to ensure compliance with current US FDA, EU, and other applicable regulatory requirements.
• Prepare Controlled Correspondence submissions and pre-ANDA meeting packages for CMC-related topics, and provide regulatory CMC support to cross-functional teams throughout the product lifecycle.
• Conduct regulatory assessments of master formula clearance, IIG clearance, device sameness, product specifications, stability protocols, scientific literature, FDA guidance and resources, and other CMC documentation to support regulatory submissions and strategies.
• Develop and implement regulatory strategies for MDI/DPI inhalation products, providing regulatory guidance from product initiation through R&D, bioequivalence execution, stability studies, and submission. Collaborate closely with Regulatory Project Managers and cross-functional stakeholders to ensure timely availability of required documentation and on-time submissions.
• Evaluate Change Controls from a Regulatory Affairs perspective, assess their potential impact on approved and planned regulatory submissions, and provide appropriate regulatory recommendations to ensure continued compliance.
• Maintain comprehensive oversight of all regulatory activities for assigned projects, ensuring project milestones, submission timelines, and performance objectives are effectively planned, monitored, and achieved.