Regulatory Strategy Manager

Vertex Pharmaceuticals; 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

General Summary

The Regulatory Strategy Senior Manager will be responsible for contributing regional or global regulatory strategy expertise for development programs or marketed products. The Regulatory Strategy Senior Manager will serve as a regional regulatory lead, or in some cases may also be a global regulatory lead, for development and/or commercial product(s) within the Vertex portfolio. This role requires understanding of regulatory affairs frameworks in the US, Europe, or other international markets, and understanding of drug development and related concepts.

Key Duties and Responsibilities

• Leads the development and implementation of regulatory strategy for assigned region as a member of the global regulatory affairs functional team
• Contributes to and may lead global regulatory strategy development for certain programs
• Responsible for regulatory communications with local health authority; may independently lead regulatory interactions with the health authority
• Provides guidance to teams on regulatory requirements for development and approval pathways for assigned region, including potential for expedited pathways
• Manages the process for preparation, submission, and approval of regulatory applications within assigned region
• Provides strategic and technical regulatory input for key product development or registration documents
• Ensures compliance of regulatory submissions with current regulations and guidance
• Reviews and evaluates regulatory intelligence and guidance information to continuously inform regulatory strategy in assigned region

Knowledge and Skills

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

Education and Experience

• Bachelor's degree in Biology, Chemistry, or other related discipline
• Typically requires 6 years of relevant pharmaceutical or biotech industry experience within regulatory affairs, 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.

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 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.

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]