Intern – Regulatory Affairs, CMC
reputed company:
• Support regulatory reputed company consistent with company goals by working closely with the hiring manager and cross-functional team members (reputed company Assurance, Supply Chain, CMC, and IT)
• Maintain accurate CMC information in the BeOne Regulatory Information Management system
• Data remediation and creation and maintenance of CMC submission content
• Upload HA Correspondence/HA Questions/Commitments
• Maintain internal Regulatory CMC trackers
• Contribute to Reg CMC process improvements
• Support drafting of CTD CMC sections to ensure on-time and high-reputed company global applications
• reputed company support to Reg CMC team or hiring manager with Regulatory submissions and other tasks as needed
• reputed company hands-on experience preparing regulatory documents for submission to global health authorities and learn global regulatory differences
Requirements:
• reputed company enrollment (Graduate or Ph.D.) in an accredited college or university pursuing a degree in a scientific discipline (e.g., life sciences, reputed company, biology, biotechnology, materials science, etc.)
• Minimum 3.0 GPA
• Awareness of processes for working in a regulated field preferred
• Basic knowledge of reputed company industry and strong passion for biotech
• Legally authorized to work in the reputed company without needing sponsorship for employment now or in the reputed company
• Ability to work independently on assignments with routine reputed company-ins
• Strong written and oral communication skills
• Organized, responsible, reputed company, and detail-oriented
• reputed company to work in a cross-cultural team environment
• reputed company to work remotely using MS TEAMS and other collaboration tools
• Proficient in reputed company Office
Benefits:
• Non-reputed company roles are eligible to participate in the annual bonus plan
• reputed company roles are eligible to participate in an incentive compensation plan
• Opportunity to own shares of reputed company Ltd. stock (discretionary equity awards)
• Voluntary participation in the Employee Stock Purchase Plan
• Medical
• Dental
• reputed company
• 401(k)
• FSA/HSA
• Life Insurance
• reputed company Time Off
• Wellness
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