Regulatory Affairs Manager 1
: Job Details :

Job Summary:This position is vital to ensuring the timely and high-quality delivery of the carve-out project, making a significant impact on the overall success of the regulatory affairs team.Key Responsibilities: Manage project prioritization and execution for the carve-out initiative, ensuring alignment with regulatory timelines and deliverables. Coordinate state and federal registration projects, streamlining processes and ensuring compliance with regional requirements. Prepare and oversee label documentation, ensuring accuracy and regulatory adherence throughout the preparation process. Interact with internal and external stakeholders, serving as a liaison to facilitate effective communication and collaboration until dossier submissions and approvals are achieved. Support the regulatory affairs team in coordinating activities related to the due diligence process, ensuring thorough evaluation and documentation. Evaluate and improve regulatory processes to enhance efficiency and compliance, contributing to overall project success. Participate in cross-functional meetings to influence project outcomes and address regulatory challenges proactively. Execute administrative functions as needed, maintaining meticulous records and documentation to support project transparency and accountability.Required Qualifications: Bachelor's degree in Administration, Engineering, or a related field. Minimum of 5 years of experience in regulatory affairs in the US and Canada and/or project management and/or administrative functions, with a demonstrated ability to navigate complex projects.Competencies: Strong team working skills and the ability to operate independently. Excellent communication skills, both written and verbal, to effectively interact with diverse stakeholders. Result-oriented mindset with a proactive approach to problem-solving. Initiative and the ability to prioritize tasks effectively. Exceptional planning and organizational skills to manage multiple projects simultaneously.Education: Bachelors Degree