Executive Director, Regulatory Strategy, Cell & Gene Therapy

Vertex Pharmaceuticals LLC; United States; Hybrid; USD 268,000 - 402,000; Full time

Job summary

Vertex Pharmaceuticals is seeking an Executive Director, Regulatory Strategy to lead global regulatory planning for the Type 1 Diabetes portfolio and to guide complex submissions from first-in-human to post-approval milestones.

The role manages a global/regional team, shapes strategic regulatory input for cross-functional programs, mentors staff, and partners with health authorities to deliver timely, compliant regulatory outcomes in a fast-paced biopharma environment.

Qualifications

• 15+ years in regulatory affairs within the pharma/biotech industry
• 7+ years of supervisory/management experience
• Experience with regulatory submissions and health authority communications

Responsibilities

• Lead regulatory strategy development for multiple T1D projects from FIH to post-marketing stages
• Coordinate input from global/regional teams to align development, clinical and commercial plans
• Advise senior management on regulatory tactics and milestones
• Mentor staff and manage resources to ensure timely, compliant deliverables

Skills

Regulatory strategy

Regulatory affairs leadership

Global regulatory knowledge

Cross-functional leadership

Education

Bachelor's degree in Biology or Chemistry

Job description

Job Description General Summary

The Executive Director, Regulatory Strategy will serve as a seasoned regulatory leader with expert technical and tactical regulatory knowledge and advanced drug development expertise in Type 1 Diabetes (T1D). The incumbent will be responsible for overseeing the development and implementation of innovative global regulatory strategies for product development and commercialization of programs within the T1D portfolio. This position will manage a group of global/regional regulatory professionals with program leadership responsibilities. This role will play a major role in shaping cohesive regulatory strategy across the programs and ensuring effective integration of broad regulatory ideas/tactics supporting franchise strategy.

Key Duties and Responsibilities

Leads the development of regulatory strategy for multiple projects in development (from FIH to post marketing application stage) within the T1D portfolio, representing regulatory on the senior cross-functional teams providing strategic input and innovative regulatory solutions and guidance for complex and/or critical topics. Ensures the global regulatory strategy for programs within the portfolio are consistent with corporate business objectives and negotiated with relevant health authorities as appropriate Works with global regulatory program leads and regional representatives to ensure unified regulatory input into cross-functional development teams, clinical programs, and commercial strategy Contributes to the review, authorship and quality of regulatory submission documents and Health Authority communications Counsels and advises senior management on status of global Regulatory Affairs strategies and tactics, procedures and practices Creates and assesses project plans and timelines and assigns and manages staff effectively to ensure all projects are appropriately prioritized and key goals are met on time. Plays a key role in developing career growth opportunities for staff Influences regulatory environment through active participation in conferences and industry/agency regulatory meeting, committees and trade associations Sponsors continuous improvement efforts on existing department processes and strategies, providing recommendations to shape the outcome. Provides recommendations for resource planning. As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills

Demonstrated technical and tactical expertise in regulatory affairs science including knowledge of regulatory frameworks and external environments. Expert knowledge of global/regional/local regulatory legislation, laws, procedure and guidance for pharmaceutical development of medicines for human use. Demonstrated expertise on research and development, preclinical and clinical requirements related to drug development, registration, and maintenance of human pharmaceuticals Expert proficiency in analyzing and interpreting data, protocols, safety reporting, labeling and other activities related to the phases of drug development for assigned products. Demonstrated advanced expertise in creating and assessing proposals to regulatory authorities on regulatory paths and clinical plans, and in leading productive health authority interactions Demonstrated advanced expertise in analyzing the adequacy of proposed regulatory pathways and strategies and guides development teams with recommendations for changes/refinements based on ongoing regulatory outcomes throughout development. Ability to navigate ambiguity, demonstrate agility, communicate a strong understanding of the requirements, opportunities, risks and alternatives for developing and maintaining products in the assigned portfolio. Builds and sustains strategic partnerships across the organization, especially with cross functional leadership for assigned portfolio. Proactively remains up to date on scientific and clinical advances, competitive intelligence and changes in the regulatory environment that impact product development for assigned portfolio. Ability to articulate the organization’s strategic vision and core values, and successfully lead and contribute to improving the quality of internal regulatory policies, programs and initiatives. A strong leader who demonstrates sensitivity and understanding of cultural considerations, embraces diversity, and continuously develops staff by providing feedback, coaching, guidance and mentoring. Enterprise minded and capable of strategic thinking and proposing innovative solutions to regulatory problems Demonstrates excellent communication skills with ability to impact and influence decisions at all levels of the organization and ability to communicate with all levels within the company and act as liaison / representative both internally and externally Expert verbal and written communicator Able to provide regulatory leadership both functionally and in a matrix environment Actively pursues innovation and excellence and is able to motivate others to pursue these values.

Education and Experience

Bachelor s degree in Biology, Chemistry, or other related discipline Typically requires 15 years of relevant pharmaceutical or biotech industry experience within regulatory affairs and 7 years of supervisory/management experience, or the equivalent combination of education and experience At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range

$268,200 - $402,200 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:

• Hybrid : work remotely up to two days per week;
• 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.