Senior Manager-Regulatory Submission Management

Responsibilities

• Accountability.
• Provide leadership and direction for the Submission Management sub-team within Submission Management.
• Accountable for performance and results of Submission Management sub-team team by coordinating and supervising work as a team leader and by monitoring progress, timeliness, completion and quality.
• Contributes to resource planning.
• Acting as SME and solving the problems.
• Supervises the day-to-day business of the Submission Management sub-team also direct support on routine submissions.
• Can perform the work supervised, but typically focuses on the more complex/complicated topics and on managing the team.
• Applies technical expertise in the analysis of factual information and may even look beyond the immediate problem and use business acumen to understand the wider implications.
• Responsible for day-to-day management, setting commitments, coaching and developing employees, performance appraisal, determination of reward outcomes.
• Ensuring sustainability of knowledge, capability, and capacity required for the book of work, aligning with long-term organizational strategies.
• Coordinating training initiatives, including onboarding of new hires, and coaching and mentoring team members.
• Collaborating with the RQS Operations team to establish KPIs and ensure adherence to them, including communication to RQS Operations functions to support overall goals.

Qualifications

• Work Experience: Around 14 years of professional experience with Regulatory Publishing Submision Management
• Key contact for eCTD and Publishing expertise.
• Act as power-user for submission applications (RIM, eDMS, eSM).
• Monitor compliance with submission standards and submission process (internal external).
• Manage and improve quality of submission standards and templates for submission-relevant documents ensuring compliance with HA requirements.

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