Job Description Summary
The Internship Program offers fresh graduates the opportunity to gain hands-on experience in a dynamic, highly regulated healthcare environment. The Regulatory Affairs Intern will support the team in preparing registration dossiers for new products, line extensions and new indications, and in maintaining existing product licenses throughout the product lifecycle. Interns will build a strong foundation in Health Authority requirements, regulatory submissions, product information and labelling, and regulatory compliance through structured learning, coaching and real-world projects.
Job Description
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.
Skills Desired