• Job Description

  Req#: R23414

  BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

  General Description/Scope of Responsibilities (Internship):

  BeiGene 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. Specifically, the intern will:

  • 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.

  Essential Functions of the Internship:

  • Responsible for maintaining 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 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
    

  Supervisory Responsibilities:

  • No

  Computer Skills: Proficient in Microsoft Office

  Other Qualifications:

  • 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

  Travel: None

  BeiGene Global Competencies

  When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity

  We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

• About the company

  BeiGene is a biotechnology company that specializes in the development of drugs for cancer treatment.

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