Senior Regulatory Strategy Lead — Global, Hybrid

Vertex Pharmaceuticals LLC; England; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

Vertex Pharmaceuticals LLC is seeking a Regulatory Strategy Senior Manager to provide regional or global regulatory strategy expertise for development programs or marketed products. The role may serve as regional or global regulatory lead for development and/or commercial products within Vertex's portfolio.

The Hybrid-Eligible or On-Site Eligible role involves leading strategy development, regulatory interactions with health authorities, and ensuring compliant submissions across US, Europe, and

Qualifications

• In-depth knowledge of global and regional regulatory affairs frameworks.
• Good understanding of drug development concepts including clinical trial design, statistics, and clinical pharmacology.
• Understanding of requirements to maintain a product on the market; reporting and surveillance.
• Ability to assess complex scientific information, regulatory precedent, competitive intelligence, and guidelines and make recommendations.
• Strong problem-solving skills.
• Strong written and verbal communication to explain difficult information and build alignment.
• Ability to work effectively within a team environment.
• Ability to plan, prioritize, and execute work and projects systematically.

Responsibilities

• Leads development and implementation of regulatory strategy for assigned region as a member of the global regulatory affairs team.
• Contributes to and may lead global regulatory strategy development for certain programs.
• Regulatory communications with local health authorities; may lead interactions with health authorities.
• Guides teams on regulatory requirements for development and approval pathways for assigned region.
• Manages preparation, submission, and approval of regulatory applications within assigned region.
• Provides input for key product development or registration documents.
• Ensures compliance of regulatory submissions with current regulations and guidance.
• Reviews regulatory intelligence to inform strategy.

Skills

Regulatory frameworks

Drug development concepts

Market maintenance

Regulatory assessment & guidance

Problem solving

Communication

Team collaboration

Planning & execution

Education

Bachelor's degree in Biology/ Chemistry

6 years regulatory affairs experience

Job description

Vertex Pharmaceuticals LLC is seeking a Regulatory Strategy Senior Manager to provide regional or global regulatory strategy expertise for development programs or marketed products. The role may serve as regional or global regulatory lead for development and/or commercial products within Vertex's portfolio.

The Hybrid-Eligible or On-Site Eligible role involves leading strategy development, regulatory interactions with health authorities, and ensuring compliant submissions across US, Europe, and