Regulatory Submission Manager

General Summary

Project manager for submission related operational aspects ranging from development through to lifecycle activities.
Taking cross- functional input, creates and manages project plans for regulatory projects and submission working
groups from authoring to dispatch/project goal delivery. Identifies operational risks with projects/submissions,
implements mitigation plans, and manages issues to closure. Provides line management to direct reports including
training, performance management, professional development, and coaching.

Primary Responsibilities
• Develops global regulatory submission plans and represents the regulatory project and submission management
group in cross- functional planning.

• Maintains effective team by recruiting, selecting, orienting, and training employees; maintaining a safe, secure, and legal
work
environment; and developing employees’ professional growth opportunities.

• Achieves staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching,
counseling, and disciplining employees; developing, coordinating, and enforcing systems, policies, procedures, and
productivity standards.

• Maintains quality service by enforcing quality and customer service standards, analyzing and resolving quality and
customer service problems, identifying trends, and recommending system improvements.

• Sets budgets, manages workload forecasting, resource balancing and ensures optimal utilization across one or more
clients.

• Proactively identifies risks and issues and proposes/implements sustainable solutions to resolve the problems and
prevent from reoccurring.

• Creates key performance indicators (KPIs) in the regulatory submission management sector and leads continuous
improvement and change.

• Provides line management to direct reports, including training, performance management, professional
development and coaching

• Maintains project and submission projections for functional planning on assigned products.

• Serves as primary contact for forecasting of global regulatory project and submission activity for strategic planning and resourcing planning purposes to ensure adequate product support.

• Plans and manages detailed project and submission timelines; provides reporting on timeline status to key stakeholders.

• Proactively raises project timeline concerns, risks and issues that may delay/impact the project and presents risk mitigation strategy.

• Drives the submission product process from pre- submission applications to marketing approval, ensuring diverse client needs are met.

• Keeps abreast of emerging and shifting regulatory environment; communicates to department leadership.

• Evaluates project and product processes and learnings across programs and recommends process changes; ensures process changes are implemented.

• 8 years of relevant experience including
• 2 years of experience in a leadership capacity in a relevant area