Director, Regulatory Submission Management (Boston)

Job Description

General Summary:

The Director, Regulatory Submission Management is accountable for the oversight and execution of a regulatory portfolio of submissions across complex 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 incumbent will focus on achieving regulatory submission activities and driving the broader GRA (Global Regulatory Affairs) 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 advanced project and portfolio plans from project initiation to closeout.
• Leads definition of the project milestones, tasks, deliverables, key dependencies and resource requirements.
• Guide the Global Regulatory Affairs Functional Team in defining and communicating regulatory project strategies across a disease area, ensuring alignment with company objectives and regulatory timelines.
• Synthesizes cross-disease area submission plans and reports that would include major milestones and key dates
• Facilitates the Global Regulatory Affairs functional team and contributes to strategic submission planning for the disease area
• Proactively leads strategies for risk mitigation and contingency planning for complex programs and submissions.
• Analyze regulatory filings (e.g., INDs, NDAs, MAAs) and provide analysis and strategies for executing across the disease area or asset
• Collaborates with management and stakeholder groups related to project status, issues, schedule and accomplishments
• Guides the team to prepare necessary reports to drive data-driven resource, budget and trade-off discussions across GRA function for complex programs
• Act as a liaison between the Global Regulatory Affairs team and other departments, ensuring clear communication and optimal collaboration.
• Fosters effective and productive communication among various Regulatory Affairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising and Promotion, Regulatory Operations, and representatives from other functional areas, as appropriate.
• Provide regular updates to senior management on project timelines, risks, and achievements.

Computer Skills

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and project management software (e.g., Smartsheet, ThinkCell, Office Timeline, MS Project)
• Proficiency with Lucid Chart or Visio
• Proficiency with Regulatory Information Management Systems, such as Veeva Vault RIM

Knowledge and Skills:

• Expertise in global regulatory filing project management
• Expertise in project management tools, such as Smartsheet or MS Project
• Expertise in Global HA submissions and requirements and guidelines
• Ability to drive firm deadlines
• Excellent organization, written/verbal communication, and attention to detail to influence other internally/externally
• Strong Stakeholder management skills including change management
• Ability to balance multiple tasks to meet priorities and timelines
• PMP or similar certification preferred
• RAC or similar certification preferred

Education and Experience:

• Bachelor's degree in life sciences, pharmacy, regulatory affairs, or related field;
• Typically requires 10 years experience in regulatory/clinical project management or the equivalent combination of education and experience

• 8 years experience in regulatory affairs or project management within the pharmaceutical/biotechnology industry
• 7-10 years experience in cross-functional project management activities
• Expertise in global regulatory submissions and familiarity with FDA, EMA, and ICH guidelines.
• Experience managing multiple Marketing Applications and/or LCM submissions at the same time and in multiple regions from submission to approval.
• Pharmaceutical development and regulatory global submissions experience.
• Experience with small molecule and/or biologics.
• Strong organizational, communication, and problem-solving skills, with a focus on continuous improvement.
• Strong PM fundamentals (meeting facilitation & management, timeline management, critical path assessment, risk and issues management).

#LI-EE1 #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