Associate Director, Regulatory Submission Management
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.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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