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Senior Manager, Regulatory Affairs Global Submission Management

Boston, MA 02210

Posted: 02/28/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 543569 Is job remote?: No Country: United States

Job Description

  • Soft Skills 
    • fast paced environment, adaptable, good communicator, management.
  • Hard Skills
    • conceptual knowledge of types of Global HA submissions, Project Management, regulatory filings, stakeholder management.
  • Education 
    • Bachelor’s degree in life sciences or technology Background 
  • Experience
    • 5+ years in submission management/regulatory affairs
General Summary: The Regulatory Submission Management Senior Manager is responsible for the planning, managing and tracking of the regulatory portfolio of submissions for an assigned program. This role will be responsible for developing comprehensive plans and reports that would include all major milestones and other key dates related to the filings. The plans would be used within regulatory to plan submission activities and resources. In addition, the plans will need to be integrated cross-functionally to ensure project team alignment on major milestones. This role will be responsible for identifying timeline risk mitigation and contingency planning within plan. This role will collaborate with key functions to collect the latest dates, understand the change drivers, update the plan and run and distribute reports to the various stakeholders. 

Key Duties and Responsibilities:
  • Leads complex project plans from project initiation to closeout.
  • Facilitates the definition of the project milestones, tasks, deliverables, key dependencies and resource requirements.
  • Develops complex project plans, status reports, issue logs, and other project-related artifacts.
  • Identifies facilitating strategies for risk mitigation and contingency planning within plan.
  • Identifies and resolves complex project plan issues and takes a new perspective on existing solutions.
  • Communicates project status, difficult or sensitive issues, schedule and accomplishments to various management and stakeholder groups, as needed, and works to build alignment
  • Prepares necessary reports to drive data-driven resource, budget and trade-off discussions across GRA function
Knowledge and Skills:
  • Experience in regulatory filing project management
  • Expertise in project management tools
  • In-depth conceptual knowledge of types of Global HA submissions and requirements and guidelines
  • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
  • Excellent organization, written/verbal communication, and attention to detail to explain difficult information and works to build alignment
  • Stakeholder management skills
  • Ability to balance multiple tasks to meet priorities and timelines
Education and Experience:
  • Bachelor’s degree in life sciences or technology area
  • Typically requires 6 years of project management experience in regulatory/clinical project management or project management experience in a life sciences company, or the equivalent combination of education and experience 
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