BeiGene · 5 hours ago

Intern - Regulatory Affairs, CMC (year-round)

United States

Internship

Remote

Intern

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BiotechnologyHealth Care

No H1B

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Responsibilities

Updated and maintain accurate CMC information in the BeiGene Regulatory Information Management system

Data remediation

Creation and maintenance of CMC Submission Content

Uploading HA Correspondence/HA Questions/Commitments

Maintain internal Regulatory CMC trackers

Contribute to Regulatory 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 Regulatory CMC team or hiring manager with Regulatory submissions and other tasks as needed

Qualification

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Regulatory CMCCTD CMC sectionsData remediationMicrosoft OfficeHealthcare industry knowledgeCross-cultural teamworkMS TEAMS

Required

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

Proficient in Microsoft Office

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

Able to work remotely using MS TEAMS and other collaboration tools