Regulatory Affairs Fellow (12 months)

Vertex Pharmaceuticals; Greater London; Hybride; GBP 30 000 - 40 000; Plein temps

Avantages offerts par ce poste

Hybrid-Eligible

On-Site Eligible

Résumé du poste

Vertex Pharmaceuticals is excited to offer a one-year Regulatory PhD Fellowship in our International Regulatory Affairs Team at our corporate headquarters in London, UK. Fellows will support regulatory development for programs and marketed products and help shape regulatory strategies for development and commercialization within the portfolio.

Key duties include contributing to regulatory strategy, preparing submissions under supervision, and ensuring compliance with current regulations while

Qualifications

• Doctoral program completed with thesis defence in a scientific field.
• Ability to understand and communicate complex scientific information.
• Strong problem-solving and analytical skills.
• Excellent written and verbal communication for complex regulatory discussions.
• Ability to work effectively in a team and manage priorities.

Responsabilités

• Contributes to development and implementation of regulatory strategy within International Regulatory Affairs.
• Develops proficiency in regulatory skills under supervision.
• Supports regulatory strategy with guidance from the International Regulatory Lead.
• Manages regulatory communications with local health authorities under supervision.
• Identifies regulatory requirements for development and approval pathways for assigned region.
• Assists in preparation, submission, and approval of regulatory applications.
• Provides regulatory input for product development/registration documents.
• Ensures regulatory submissions comply with current regulations and guidance.
• Reviews regulatory intelligence to support strategy.

Connaissances

Regulatory strategy

Written and verbal communication

Teamwork

Problem-solving

Planning and prioritization

Formation

PhD completed

Description du poste

Vertex Pharmaceuticals is excited to offer our Regulatory PhD Fellowship program. Vertex is offering a one-year PhD Fellowship in our International Regulatory Affairs Team at our corporate headquarters in London, UK.

The Regulatory PhD Fellows will be responsible for regulatory support for development programs or marketed products. The Fellow will contribute to the development of regulatory strategies for development and commercialization of program(s) within the portfolio.

Key Duties & Responsibilities:

• Contributes to the development and implementation of regulatory strategy as a member of the International Regulatory Affairs Team
• Develops proficiency in regulatory skills
• Supports regulatory strategy under guidance of the International Regulatory Lead
• Responsible for regulatory communications with local health authority; under supervision
• Identifies regulatory requirements for development and approval pathways for assigned region
• Under supervision, manages the process for preparation, submission, and approval of regulatory applications
• Provides technical regulatory input for key product development or registration documents
• Works to ensure compliance of regulatory submissions with current regulations and guidance
• Reviews regulatory intelligence and guidance information to continuously support regulatory strategy

Required Education and Knowledge/Skills:

• Successfully completed a Doctoral program and thesis defence in a scientific background
• Ability to assess and understand complex scientific information
• Strong problem-solving skills
• Strong written and verbal communication skills to exchange complex information with others in complex situations
• Ability to work effectively within a team environment
• Ability to plan, prioritize, and contribute to work and projects in a systematic and efficient manner
• Ability to start in summer/Autumn 2027 at our International HQ in Paddington, London.

Our Ways of Working:

Flex @ Vertex details

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.

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]