Senior Manager-Regulatory Submission Management

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.

Work Experience:

*Around 14 years of professional experience with Regulatory Publishing & Submision Management

Job Specific Competencies:

*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