Be exposed to the broad scope of global Regulatory Affairs and specifically CMC Regulatory Affairs and the role’s contribution to drug development and patients’ access to medicines.
Learn about the role of global Health Authorities in the drug development process.
Gain hands-on experience in preparing regulatory documents for submission to global health authorities.
Acquire knowledge about the differences in regulatory requirements across regions.
Experience CMC technical product development and manufacturing functions in relation to regulatory affairs.
Responsible for maintaining accurate CMC information in the BeOne Regulatory Information Management system.
Data remediation.
Create and maintain CMC Submission Content.
Upload HA Correspondence/HA Questions/Commitments.
Maintain internal Regulatory CMC trackers.
Contribute to Reg CMC process improvements.
Support the drafting of CTD CMC sections to ensure on-time and high-quality global applications for direct submission to Health Authorities as needed.
Provide support to Reg CMC team or hiring manager with Regulatory submissions and other tasks as needed.

Active enrollment (Graduate or Ph.D.) in an accredited college or university pursuing a degree in a scientific discipline (e.g., life sciences, chemistry, biology, biotechnology, materials science, etc.) with a minimum 3.0 GPA
Awareness of processes for working in a regulated field preferred
Basic knowledge of healthcare industry and strong passion for biotech
Legally authorized to work in the United States without needing sponsorship for employment now or in the future
Ability to work independently on assignments with routine check-ins
Strong written and oral communication skills
Organized, responsible, resourceful, and detail-oriented
Able to work in a cross-cultural team environment with members across different time zones
Able to work remotely using MS TEAMS and other collaboration tools

Intern – Regulatory Affairs, CMC

Key skills