Intern - Regulatory Affairs, CMC (year-round)

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 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):

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. 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.

• Acquire knowledge about 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 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

• 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

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 with members across different time zones

• Able to work remotely using MS TEAMS and other collaboration tools

Travel: None

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, 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

Salary Range: $ - $ per hour

BeOne 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 BeOne Medicines 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. BeOne 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [e-mail].