Regulatory Affairs Intern
novartis · Riyadh
وصف الوظيفة
About the role
Novartis offers a Regulatory Affairs Internship in Riyadh for fresh graduates, giving them hands-on experience in a highly regulated healthcare environment. The intern supports the team in preparing registration dossiers for new products, line extensions and new indications, and in maintaining existing product licenses throughout their lifecycle. Learning is built around structured coaching and real-world projects.
Key responsibilities
- Support the preparation of registration dossiers in line with the regulatory strategy and submission timelines.
- Assist with lifecycle maintenance activities such as variations, renewals and safety label changes.
- Monitor national regulatory guidelines and summarize updates and Health Authority communications for the manager and team.
- Track product information updates from submission through approval and help develop approved artwork (e.g. in OneArt).
- Maintain accurate data in regulatory information management systems and RA tools (e.g. DRAGON and NRV) and archive documents in the designated record locations.
- Keep global surveys, trackers and compliance reports (e.g. SALTO) up to date in line with local regulations.
- Help prepare and submit scientific lecture packages.
- Support line-manager initiatives while complying with Novartis policies, local and global SOPs/WPs, ethical standards and regulations.
Required profile
- Bachelor's degree in Pharmacy (fresh graduate); no prior work experience required.
- Internship or training experience, research projects or university initiatives in regulatory affairs, pharma or life sciences are an advantage.
- General awareness of country Health Authority regulations is an advantage.
- English and Arabic.
Required skills
- Proficiency in Microsoft Office (Word, Excel and PowerPoint).
- Analytical thinking, attention to detail and good organization.
- Ability to collaborate across functions and adapt to a fast-paced environment.
Questions fréquentes
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اكتشف المزيد
الرواتب والأدلة وعمليات البحث في المملكة العربية السعودية.
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novartis
Riyadh