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

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 canchoose to work:

1.Hybridand work remotely up to two days per week;or select

2.On-Site andwork 5 days per week with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

Flex Designation:

Flex Eligibility Status:

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.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com