Remote Reg CMC Intern — Biotech Submissions

BeiGene; United States; Remote; USD 25,000 - 39,000; Full time

Job summary

BeOne Medicines Ltd. seeks a motivated Reg CMC Intern to support global regulatory submissions and CMC data management in a fast-paced biotech setting. You will work closely with the Reg CMC team and cross-functional partners to advance drug development and health authority interactions.

Responsibilities include maintaining CMC data, drafting submission content, and assisting with process improvements. Strong communication and organizational skills are essential, with remote work available

Qualifications

• Active enrollment in a graduate or PhD program in a scientific discipline with a 3.0 GPA.
• Interest or experience in regulated fields preferred.
• Legally authorized to work in the United States without sponsorship now or in the future.

Responsibilities

• Maintain CMC information in 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.
• Assist in drafting CTD CMC sections for global submissions.
• Provide support to Reg CMC team on regulatory submissions.

Skills

Microsoft Office

Regulatory knowledge

Communication skills

Team collaboration

Data management

Education

Graduate/PhD student in life sciences

Tools

Microsoft Teams

Job description

BeOne Medicines Ltd. seeks a motivated Reg CMC Intern to support global regulatory submissions and CMC data management in a fast-paced biotech setting. You will work closely with the Reg CMC team and cross-functional partners to advance drug development and health authority interactions.

Responsibilities include maintaining CMC data, drafting submission content, and assisting with process improvements. Strong communication and organizational skills are essential, with remote work available