Intern - Regulatory Affairs CMC
Intern - Regulatory Affairs CMC
Posted on :
24-01-2025
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1 Vacancy
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Job Description
Job Title: Intern Regulatory Affairs CMC (yearround)
Job Location: United States
Job Location Type: Remote
Job Contract Type: Parttime
Job Seniority Level: Internship
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.
Requirements
The Regulatory Affairs CMC Intern will support regulatory projects consistent with company goals by working closely with the hiring manager and crossfunctional 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:
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.) with a minimum 3.0 GPA
Computer Skills: Proficient in Microsoft Office
Other Qualifications
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 jobrelated 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. NonCommercial 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.
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.
Requirements
The Regulatory Affairs CMC Intern will support regulatory projects consistent with company goals by working closely with the hiring manager and crossfunctional 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 handson 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.
- 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 ontime and highquality 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.
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.) with a minimum 3.0 GPA
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 checkins
- Strong written and oral communication skills
- Organized responsible resourceful and detailoriented
- Able to work in a crosscultural team environment
- Able to work remotely using MS TEAMS and other collaboration tools
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
- SelfAwareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- ResultsOriented
- 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 jobrelated 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. NonCommercial 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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Employment Type
Full Time
Key Skills
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