Regulatory Affairs Intern (Ha Noi)

Job Description Summary

The intern will provide hands-on support across regulatory tracking, artwork confirmation, and preparation of lower-complexity post-approval change dossiers. This role offers an excellent opportunity to gain practical exposure to pharmaceutical regulatory affairs while contributing to the accuracy and efficiency of regulatory operations.

Job Description

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

We are looking for a detail-oriented and motivated Regulatory Affairs Intern to join our Drug Regulatory Affairs (DRA) team in Vietnam.

The intern will provide hands-on support across regulatory tracking, artwork confirmation, and preparation of lower-complexity post-approval change dossiers. This role offers an excellent opportunity to gain practical exposure to pharmaceutical regulatory affairs while contributing to the accuracy and efficiency of regulatory operations.

Key Responsibilities

• Support the DRA team in maintaining timely and accurate tracking of regulatory activities and dossier status across relevant systems and tools.
• Perform routine data updates and maintenance to ensure regulatory information is complete and up to date.
• Support artwork (AW) review and re-confirmation activities, including documentation and status tracking.
• Assist with the preparation and coordination of lower-complexity post-approval change dossiers under the guidance of the DRA team.
• Support the organization and maintenance of regulatory documentation.
• Help identify opportunities to simplify and enhance local regulatory tracking processes.
• Follow up on assigned activities to support timely completion of regulatory deliverables.
• Provide other operational and administrative support to the DRA team as required.

Minimum Requirements

• Final-year student pursuing a Bachelor's degree in Pharmacy or another relevant discipline.
• Minimum GPA of 3.0/4.0 or equivalent.
• Strong attention to detail and ability to work accurately with a high volume of information and documentation.
• Good organizational and time-management skills.
• Good knowledge of Microsoft Excel and Microsoft Office applications; experience with data tracking or reporting tools would be an advantage.
• Good communication and collaboration skills.
• Good command of English and Vietnamese.
• Interest in pharmaceutical regulatory affairs and willingness to learn about regulatory processes and requirements.

What You Will Learn

• Practical exposure to Drug Regulatory Affairs in the pharmaceutical industry.
• Understanding of regulatory dossier tracking, artwork management, and post-approval change activities.
• Experience working with regulatory documentation and tracking systems.
• Opportunities to develop skills in data accuracy, process improvement, regulatory compliance, and cross-functional collaboration.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!            

 

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

#Sandoz

Skills Desired