Executive Director, Regulatory Strategy, Cell & Gene Therapy

Vertex Pharmaceuticals Inc (US); United States; Hybrid; USD 268,000 - 402,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Generous paid time off

Commuting subsidy

401(k)

Job summary

Vertex Pharmaceuticals is seeking an Executive Director, Regulatory Strategy to lead global regulatory strategies for the Type 1 Diabetes portfolio. You will oversee a team of regulatory professionals, work with cross-functional development teams, and influence regulatory pathways and submissions to support product development and commercialization.

The role emphasizes senior leadership, strategic input, and collaboration across functions to ensure alignment with corporate objectives and

Qualifications

• Bachelor's degree required in Biology, Chemistry, or related discipline.
• 15 years of relevant pharmaceutical or biotech regulatory affairs experience.
• 7 years of Supervisory/management experience or equivalent combination.

Responsibilities

• Leads development of regulatory strategy for multiple projects within Type 1 Diabetes portfolio from FIH to post marketing.
• Ensures global regulatory strategy aligns with corporate objectives and negotiates with health authorities as appropriate.
• Collaborates with global/regional teams to provide unified regulatory input into development programs and commercial strategy.
• Contributes to review and quality of regulatory submission documents and health authority communications.
• Counsels senior management on status of regulatory strategies, procedures and practices.
• Manages staff and resources to prioritize projects and meet key milestones.
• Influences regulatory environment through participation in conferences and industry/regulatory meetings.

Education

Bachelor's degree in Biology, Chemistry, or related discipline

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 *LI-EE1 *LI-Hybrid 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
• 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. #LI-Hybrid

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 [e-mail]

Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.