Senior Executive, Regulatory Affairs - Injectable

The role involves compiling, preparing, reviewing, and submitting ANDA submissions and Amendments to FDA with the aim of avoiding major deficiencies and obtaining approval within the shortest possible timeframes. It is essential to stay informed about all regulatory activities on assigned projects, set and meet project deadlines and performance standards. Expertise or prior experience in Sterile dosage form ANDAs is required, particularly in areas such as Injectables, Ophthalmic, Otic, and IV Bags with knowledge of Aseptic sterilization, Terminal sterilization, or both techniques. Timely submission of assigned projects, review, and preparation of documents meeting US FDA requirements without query or RTR are key responsibilities. It is important to evaluate change controls, formulate filing strategies, and proactively address major issues. Collaboration with various departments during product initiation, R&D phase, ANDA/Bio Execution, and post-stability initiation is necessary for timely document availability and submissions. Additionally, preparing controlled correspondence and meeting packages for FDA on specific issues, assessing deficiency letters, and developing regulatory strategies are crucial tasks. The position requires maintaining accuracy and attention to detail, excellent written and verbal communication skills, and prior experience with ANDAs, INDs, NDAs, and FDA correspondences. Time management, organization, and multitasking abilities in a fast-paced environment are essential. Effective communication and collaboration within a team, working independently, and adhering to regulatory guidelines are important aspects of the role. Strong computer skills, familiarity with ICH, FDA, and 21 CFR regulations, and the ability to handle administrative functions to support projects are also necessary. The required skills include expertise in regulatory submission and dossier filing, regulatory guidelines knowledge, cross-functional communication, change management, problem-solving, product lifecycle management, CMC documentation, health authority query response, and regulatory strategy development. The qualifications needed for this role include an M. Pharm degree. Amneal is an equal opportunity employer that values diversity and inclusion in the workplace. The Human Resources team plays a vital role in the organization, providing support in people management, compliance, talent acquisition, learning and development, reward systems, and performance management. They also offer expert advice on workforce management, employee relations, and stay updated on developments impacting employment matters.,