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Regulatory Submission Manager

  1. India
2022-96947
  1. ICON Strategic Solutions
  2. Regulatory Affairs

About the role

This vacancy has now expired. Please click here to view live vacancies.

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
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