Executive Director, Global Regulatory Operations (Boston, MA)

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 :

Education and Experience :

Pay Range : $244,000 - $366,000

Disclosure Statement :

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation :

Hybrid-Eligible Or On-Site Eligible

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

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