Vertex Pharmaceuticals
Executive Director, Global Regulatory Operations (Boston, MA)
Vertex Pharmaceuticals, Boston, Massachusetts, us, 02298
Overview
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. Responsibilities
Lead the Submissions Management & Publishing groups, and the delivery of quality global dossiers to health authorities using effective planning and publishing standards. Oversee the strategic direction of key tools and processes in the advancement of effective dossier delivery in line with industry tool/process advancements. Lead 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. Lead the Regulatory Management office in driving the operational, strategic and financial elements of the entire GRA function, including budgets, contracts, Long-Range Plan (LRP), resource and organizational design, communications and strategic outsourcing partnerships. Drive partnerships with key submission stakeholders in the development of timelines and document delivery, dashboards, status reporting and coordination of program level milestones related to the submission. Drive the future evolution of technology within GRA, ensuring industry and regulatory developments are incorporated. Lead the regulatory information management framework, document management and tracking within RIM tools/processes. Lead 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 Compensation and Company Information
LI-EE1 #LI-Hybrid Pay Range: $244,000 – $366,000. This range is a reasonable base salary estimate at the time of posting. The 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. Base salary is based on factors including skills, competencies, experience, and other job-related factors permitted by law. Vertex offers Total Rewards including comprehensive benefits to support employees and their families, with medical, dental, vision, 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 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 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 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 should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com Vertex Pharmaceuticals
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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. Responsibilities
Lead the Submissions Management & Publishing groups, and the delivery of quality global dossiers to health authorities using effective planning and publishing standards. Oversee the strategic direction of key tools and processes in the advancement of effective dossier delivery in line with industry tool/process advancements. Lead 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. Lead the Regulatory Management office in driving the operational, strategic and financial elements of the entire GRA function, including budgets, contracts, Long-Range Plan (LRP), resource and organizational design, communications and strategic outsourcing partnerships. Drive partnerships with key submission stakeholders in the development of timelines and document delivery, dashboards, status reporting and coordination of program level milestones related to the submission. Drive the future evolution of technology within GRA, ensuring industry and regulatory developments are incorporated. Lead the regulatory information management framework, document management and tracking within RIM tools/processes. Lead 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 Compensation and Company Information
LI-EE1 #LI-Hybrid Pay Range: $244,000 – $366,000. This range is a reasonable base salary estimate at the time of posting. The 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. Base salary is based on factors including skills, competencies, experience, and other job-related factors permitted by law. Vertex offers Total Rewards including comprehensive benefits to support employees and their families, with medical, dental, vision, 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 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 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 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 should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com Vertex Pharmaceuticals
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