Job Description

Position: CMC - Senior Manager I Location : Hyderabad (Hybrid) Position Responsibilities: Senior Manager - I is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions . Key Responsibilities Support project matrix teams for pipeline products from development through completion of post-marketing commitments & relevant lifecycle management projects driven by research, such as pediatric formulations and line extensions. Provide strategic CMC regulatory expertise for development project teams. Provide strategic input to development and commercial teams to mitigate drug supply issues. Interpret global regulations and guidance. Identify, communicate and propose resolution to routine issues. Participate in product fact finding meetings. Interface (either directly or indirectly) with the US FDA for CMC submissions and CMC-related issues. Communicate with project teams; in particular with regards to technical issues that may impact regulatory submissions, strategy, or success. Provide technical teams insight into regulatory health authority expectations. Identify potential risks & help technical teams to formulate mitigation strategies to ensure regulatory success. Ensure the necessary updates are provided to team leaders. Qualifications & Experience: 3-5+ years pharmaceutical or related experience. 2+ years CMC regulatory or related experience. Knowledge of global CMC regulatory requirements for pharmaceutical small molecules and/or biologic products during development and post-approval. Demonstrated ability to develop/maintain strong working relationships with cross functional teams, participate on and/or lead multifunctional teams, and handle/prioritize multiple projects and work independently. Ability to identify, communicate and resolve routine/complex issues. Prepare and manage filings and ensure thoroughness, accuracy and timeliness. Ability to interpret global regulations and guidance documents. Strong oral and written skills. Proficient with electronic systems.

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