Regulatory Affairs Intern

Major Accountabilities

·  Support the preparation of registration dossiers for new products, line extensions and new indications, in line with the regulatory strategy and planned submission timelines.

·  Assist with lifecycle maintenance activities, including variations, renewals and safety label changes (SLCs).

·  Help monitor national regulatory guidelines and requirements and summarize relevant updates and Health Authority communications for the manager and team.

·  Support the tracking of product information updates from submission through approval, and assist in developing artwork (e.g., in OneArt) in accordance with Health Authority-approved product information.

·  Maintain accurate, up-to-date data in Regulatory Information Management systems and RA tools (e.g., DRAGON & NRV), and archive regulatory documents in the designated record locations.

·  Support the team in keeping global surveys, trackers and compliance reports (e.g., SALTO) up to date in line with effective local regulations.

·  Assist in preparing & submitting scientific lectures packages.

·  Support initiatives assigned by the line manager while ensuring full compliance with Novartis policies, local and global SOPs/WPs, ethical standards and local regulations.

Key Performance Indicators

·  Timely completion of assigned tasks and projects.

·  Accuracy and quality of dossier documents, trackers, reports and regulatory records.

·  Accurate and up-to-date information in regulatory databases and systems.

·  Adherence to SOPs/WPs and completion of all assigned training within the required timelines.

·  Active participation in learning and development activities.

·  Demonstrates collaboration, accountability, innovation and a growth mindset.

·  Positive feedback from manager and cross-functional stakeholders.

Minimum Requirements/Work Experience

·  Education: Bachelor’s degree in pharmacy (fresh graduate).

·  Work Experience: No prior work experience required.

·  Internship or training experience, research projects or university initiatives in regulatory affairs, the pharmaceutical industry or life sciences are an advantage.

·  General awareness of country Health Authority regulations and guidelines is an advantage.

Skills

·  Strong communication and interpersonal skills.

·  Analytical and problem-solving abilities, with strong attention to detail.

·  Good organizational skills and the ability to work on several tasks with tight timelines.

·  Interest in regulatory affairs, regulatory science and the pharmaceutical product lifecycle.

·  Proficiency in Microsoft Office (Word, Excel and PowerPoint).

·  Ability to work collaboratively across multiple functions.

·  Eagerness to learn and contribute in a fast-paced environment.

Languages

·   English.

·   Arabic.