Senior Executive, Regulatory Affairs

Key Responsibilities

1. 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.
2. Perform comprehensive regulatory evaluations of assigned drug products to ensure compliance with current US FDA, EU, and other applicable regulatory requirements.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. Maintain comprehensive oversight of all regulatory activities for assigned projects, ensuring project milestones, submission timelines, and performance objectives are effectively planned, monitored, and achieved.

Additional Responsibilities:

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

• 5 years or more in 5 - 8 Years