Intern - Regulatory Affairs, CMC (year-round)

BeiGene

11d•Remote

About The Position

BeOne is seeking a motivated and talented individual to join our Reg CMC small molecule team which offers meaningful project experiences that gives interns the opportunity to gain valuable Biotech experience as they complete their academic journey. The Regulatory Affairs CMC Intern will support regulatory projects consistent with company goals by working closely with the hiring manager and cross-functional team members, including Quality Assurance, Supply Chain, CMC, and IT. The focus of the internship is for the intern to develop a deeper understanding of the drug development process and regulatory requirements in a professional work environment, while contributing to process optimization in knowledge management.

Requirements

Active enrollment (Graduate or Ph.D.) in an accredited college or university pursing a degree in a scientific discipline (e.g., life sciences, chemistry, biology, biotechnology, materials science, etc.) with a minimum 3.0 GPA
Proficient in Microsoft Office
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

Responsibilities

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