The Regulatory Delivery Excellence (RDE) Manager is responsible for the recruitment, retention and resource assignment of the regulatory associates managing submissions in the Global Regulatory Affairs (GRA) organization. The RDE Manager provides leadership, direction, as well as technical / process expertise to the regulatory associates responsible for the regulatory submission management process across the CTD modules. This position provides strategic input, focuses on results, thinks critically, and emphasizes and drives regulatory team collaboration to the achievement of goals and objectives. The RDE Manager leads the regulatory associates responsible for the execution and delivery of submissions to global health authorities. The RDE Manager supports execution of the submission plans that are aligned with the molecule team. To achieve this goal, the RDE Manager uses their regulatory and submission expertise, a strong working knowledge of customers, internal procedures, guidances and regulatory precedence.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Minimum Qualification Requirements:
Other Information/Additional Preferences:
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