Job Description
The Associate Director, Regulatory Submission Management is responsible for the planning, managing and tracking of the regulatory portfolio of submissions across a number of assigned programs. This role will be responsible for driving comprehensive plans and reports that would include all major milestones and other key dates related to the filings. The role will focus on achieving regulatory submission activities and driving the broader GRA team to ensuring all deliverables are met. This role will be responsible for driving timeline risk mitigation and contingency planning.
Key Duties and Responsibilities:
Oversees complex project and portfolio plans from project initiation to closeout.
Drives the definition of the project milestones, tasks, deliverables, key dependencies and resource requirements.
Oversees the development of project plans, status reports, issue logs, and other project-related artifacts.
Leads strategies for risk mitigation and contingency planning within plan. Efficiently identifies and resolves project issues within the team and drives the resolution to completion.
Manages project status, issues, schedule and accomplishments and communicates to various management and stakeholder groups, as needed.
Leads and manages members of submission management team.
Leads the preparation of necessary reports to drive data-driven resource, budget and trade-off discussions across the GRA function.
As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.
Knowledge and Skills:
Expertise in global regulatory filing project management
Expertise in project management tools
Comprehensive understanding of types of Global HA submissions and requirements and guidelines
Ability to drive firm deadlines and adapt quickly to changing requirements and priorities
Excellent organization, written/verbal communication, and attention to detail to persuade managers and leaders to take action
Stakeholder management skills
Ability to balance multiple tasks to meet priorities and timelines
Supervisory/management experience
Education and Experience:
Bachelor’s degree in life sciences or technology area
Typically requires 8 years of project management experience in regulatory/clinical project management or project management experience in a life sciences company and 2 years of supervisory/management experience, or the equivalent combination of education and experience
We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:
1. Hybrid and work remotely up to two days per week; or select
2. On-Site and work 5 days per week with ad hoc flexibility.
Associate Director, Regulatory Submission Management • Boston, MA
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