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.
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
Support management of regulatory impact assessments and actions resulting from change controls.
Hours: 20 hours/week for 6-12 months
Additional hours may be required on occasion
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.) Â with a minimum 3.0 GPA
Computer Skills:Â Â Proficient in Microsoft Office
Other Qualifications: Â Â
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:Â 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.
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.
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