Remote
3 days ago
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 TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity

Salary Range: $ - $ per hour

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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