Executive Director, Global Regulatory Operations (Boston, MA)

Job Description

General Summary:

The Executive Director, Regulatory Operations is responsible for leading the teams of publishing, submission management, regulatory information management, compliance and the regulatory management office. This role will be accountable for creating a high quality organization that utilizes the best in technology, process and project management to deliver global submissions in a highly effective and efficient way. This role will drive the strategic framework for how GRA operates as a group including centralized oversight of functional strategic objectives.

Key Duties and Responsibilities:

• Leads the Submissions Management & Publishing groups, and the delivery of quality global dossiers to HAs utilizing effective planning and publishing standards
• Oversees the strategic direction of key tools and processes in the advancement of effective dossier delivery in line with industry tool/process advancements
• Leads Regulatory compliance by driving compliant processes and adherence to standards/procedures by GRA. Monitor, track and implement process improvements through identification of trends and gaps
• Leads the Regulatory Management office in driving the operational, strategic and financial elements of entire GRA function, including but not limited to budgets, contracts, Long-Range Plan (LRP), resource and organizational design, communications and strategic outsourcing partnerships
• Drives the partnership with key submission stakeholders in the development of timelines and document delivery as well as dashboards, reporting of status and coordination of program level milestones related to the submission
• Drives the future evolution of technology within GRA, ensuring industry and regulatory developments are incorporated. Leads the regulatory information management framework, document management and tracking within RIM tools/processes
• Leads the regulatory information/documentation repository/archive team to ensure compliant records and oversight of key regulatory documentation and commitments for inspections
• As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills:

• Proven ability for building and leading high performance global regulatory operations teams
• Excellent communication and influencing ability to lead large groups and stakeholders on change initiatives
• Ability to keep teams focused on results for the wider organization
• Ability to cultivate a high achievement organization; effective as a mentor and coach; able to attract, develop, motivate and retain staff
• Credible technology leader able to partner with GIS/innovation groups in evolving business needs
• Broad knowledge of the global regulatory and compliance environment in anticipation of future trends and impact.
• Strong understanding of the drug development process.
• Excellent relationship management both with internal stakeholders and external vendor partners
• Excellent organizational and project management skills and ability to think strategically.

Education and Experience:

• Bachelor's degree in a relevant life sciences/technology or business disciplines
• Typically requires 15 years experience in pharmaceutical/life sciences industry and 7 years of supervisory/management experience building and leading global regulatory operations teams, or the equivalent combination of education and experience

#LI-EE1 #LI-Hybrid

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

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