Regulatory Affairs Fellows Programme
Vertex Pharmaceuticals
Regulatory Affairs Fellows Programme
Salary Not Specified
Vertex Pharmaceuticals, City of Westminster
- Full time
- Permanent
- Onsite working
Posted today, 1 Oct | Get your application in now to be one of the first to apply.
Closing date: Closing date not specified
job Ref: c723b97304b54741be77c3fceff66211
Full Job Description
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, may lead regulatory interactions with the health authority
- 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
- Informs regulatory affairs senior management on the status of regulatory strategies and tactics, procedures and practices
- Works to ensure compliance of regulatory submissions with current regulations and guidance
- Reviews regulatory intelligence and guidance information to continuously support regulatory strategy
Successfully completed a Doctoral program and thesis defense 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 2025 at our International HQ in Paddington, London.