Regulatory Affairs Postgraduate Program UK

Position Overview

The Regulatory Affairs Postgraduate Training Program offers a two-year training experience comprising two one-year rotational assignments in distinct RA functions. Participants will gain exposure to global Regulatory Affairs, Regulatory Chemistry, Manufacturing and Controls across a leading global healthcare company.

Responsibilities

• Interact with global interdisciplinary project teams to provide strategic regulatory input for development, submission planning, documentation and timelines.
• Support and/or prepare high-quality dossiers and drug substance/drug product quality documentation for global regulatory submissions (e.g., Clinical Trial Applications, Market Authorization Applications, post-approval variations).
• Adapt dossiers to meet specific requirements in various countries and regions.
• Plan, prepare, review, coordinate and submit regulatory submissions and responses.
• Ensure regulatory compliance by creating awareness of requirements and guidelines, facilitating timely submission of variations, and participating in the change control process.
• Develop and maintain globally consistent product information.
• Support the Regulatory Intelligence group in analysing the EU regulatory framework and informing the internal RA community.
• Monitor, search for and evaluate legislation and guidelines from different sources.

Qualifications

• Strong interest in Regulatory Affairs and drug development.
• Completion of an MSc, PhD or PharmD in Pharmaceutical Sciences, Pharmacy, Life Sciences or an equivalent within the last 24 months.
• Fluency in English (written and spoken).
• Open-minded with an international outlook and ready to expand knowledge.
• Strong interpersonal skills; ability to communicate effectively across cultures and hierarchies.

Program Details

Duration: 2 years, with expected start date January 2027.

Legal Notice

Novartis is an equal-opportunity employer committed to embracing and leveraging diverse backgrounds. Applicants must be eligible to work in the United Kingdom.