Senior Executive, Regulatory Affairs

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Amneal Pharmaceuticals seeks regulatory affairs professionals to manage US ANDA and EU submissions for MDI/DPI inhalation products. You will evaluate regulatory requirements and coordinate CMC documentation across cross-functional teams to ensure timely submissions.

The role involves reviewing DMFs, providing regulatory comments, and maintaining oversight of project timelines and submission milestones within a fast-paced environment.

Qualifications

• Experience preparing US ANDA and EU marketing authorization submissions.
• Regulatory evaluation of drug products for FDA, EU and other requirements.
• Coordinate CMC documentation and DMF interactions with cross-functional teams.

Responsibilities

• Compile, prepare, review, and submit US ANDA and EU submissions for inhalation products.
• Perform regulatory evaluations to ensure compliance with applicable requirements.
• Prepare CMC submissions and provide regulatory CMC support across the lifecycle.
• Conduct DMF reviews and provide regulatory comments to procurement/DMF holders.
• Maintain oversight of regulatory activities, milestones, and timelines.

Skills

Regulatory affairs

US FDA submissions

EU regulatory submissions

CMC documentation

DMF reviews

Cross-functional collaboration

Job description

• 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.
• Actively participate in cross-functional team (CFT) meetings and discussions with device suppliers to ensure CMC documentation and development activities remain aligned with regulatory expectations.
• Ensure that final US ANDA and EU submissions comply with the latest US FDA ANDA Checklist, EU regulatory requirements, and applicable guidance documents to minimize the risk of Refuse-to-Receive (RTR) or validation deficiencies.
• 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.
• Perform detailed reviews of Drug Master Files (DMFs) and provide timely regulatory comments to the Procurement/Purchasing team. Coordinate with procurement and DMF holders, as required, to ensure timely resolution of comments and regulatory compliance.
• 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.