Director, Regulatory Strategy, Cell & Gene Therapy

Director, Regulatory Strategy, Cell & Gene Therapy

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Position Overview

The Director, Regulatory Strategy will develop and implement innovative global/regional regulatory strategies for projects within Vertex's cell and gene therapy portfolio. This role involves shaping cohesive regulatory strategies, integrating broad regulatory ideas/tactics to support program objectives, and translating regulatory, scientific, operational, and business knowledge into effective plans. Assignments may be global or regional.

Key Responsibilities

1. Develop regulatory strategies for projects from first-in-human to post-marketing stages, documented in Global Regulatory Strategy Documents.
2. Represent GRA on development and project teams, collaborating with regional leaders to ensure unified regulatory input.
3. Address complex regulatory issues with innovative solutions, guiding cross-functional teams and communicating effectively.
4. Anticipate regulatory changes and develop proactive strategies.
5. Shape regulatory submissions and health authority communications.
6. Advise GRA leadership on regulatory strategies, procedures, and practices.
7. Ensure strategies align with business objectives and comply with regulations.
8. Manage project plans and timelines to meet goals.
9. Contribute to continuous process improvements within the department.
10. Provide regulatory leadership and mentorship to teams.

Qualifications and Skills

• Experience in Regulatory Affairs strategy within assigned regions, including stakeholder interactions.
• Advanced knowledge of regulatory frameworks, legislation, and guidance for pharmaceuticals.
• Understanding of drug development, registration, and maintenance processes.
• Proficiency in data analysis, protocol review, safety reporting, and labeling.
• Expertise in regulatory proposal development and health authority interactions.
• Mentoring and coaching abilities.
• Strong collaboration, communication, and influence skills.

Education and Experience

• Bachelor's degree in Biology, Chemistry, or related field.
• Typically 10+ years of relevant experience in pharmaceutical or biotech regulatory affairs.

Additional Details

Pay range: $194,400 - $291,600, plus bonus and equity. The role offers hybrid or on-site work options, with flexible policies. Vertex provides comprehensive benefits, including health coverage, paid time off, educational assistance, and more.