Intern - Regulatory Affairs, CMC (year-round)

BeiGene

104d

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 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.
• 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.
• Raise awareness of 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.
• Creation and maintenance of CMC Submission Content.
• Uploading 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.

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness
• Opportunity to own shares of BeOne Medicines Ltd. stock through discretionary equity awards and Employee Stock Purchase Plan.

What This Job Offers

• Career Level: Intern
• Education Level: Master's degree