Regulatory Affairs Intern

Novartis AG; Riyadh; On-site; SAR 8,900 - 13,000; Full time

Job summary

Novartis AG in Riyadh offers an Internship Program for fresh graduates to gain hands-on experience in a regulated healthcare environment. The Regulatory Affairs Intern will support the team in preparing registration dossiers for new products, line extensions and new indications, and help maintain licenses throughout the product lifecycle.

Interns will learn Health Authority requirements, regulatory submissions, labeling and compliance through structured learning, coaching and real-world

Qualifications

• Bachelor's degree in pharmacy and fresh graduate status.
• No prior work experience required.
• Internship or training in regulatory affairs is an advantage.
• Knowledge of country Health Authority regulations is an advantage.

Responsibilities

• Support preparation of registration dossiers for new products, extensions and indications.
• Assist lifecycle maintenance activities including variations and renewals.
• Monitor regulatory guidelines and summarize updates for the team.
• Maintain data in Regulatory Information Management systems and archive documents.
• Support global surveys, trackers and compliance reports up to date.
• Assist in preparing and submitting scientific lectures packages.
• Ensure compliance with Novartis policies and local regulations.

Skills

Strong communication and interpersonal

Analytical and problem-solving

Good organizational skills

Regulatory affairs interest

Microsoft Office proficiency

Cross-functional collaboration

Eagerness to learn in fast-paced env

Education

Bachelor's degree in pharmacy

Tools

OneArt

DRAGON

NRV

Job description

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.