Intern - Regulatory Affairs, CMC (year-round)

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.

Essential Functions of the Internship:

• 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
   

Supervisory Responsibilities:  

• No

Computer Skills:   Proficient in Microsoft Office

Education Required: 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

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

BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

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.