Product Manager
Azenta Life Sciences
Intern – Regulatory Affairs, CMC
BeOne Medicines
part-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Entry Level
About the role
- Support regulatory projects consistent with company goals by working closely with the hiring manager and cross-functional team members (Quality 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-quality global applications
- Provide support to Reg CMC team or hiring manager with Regulatory submissions and other tasks as needed
- Gain hands-on experience preparing regulatory documents for submission to global health authorities and learn global regulatory differences
Requirements
- Active enrollment (Graduate or Ph.D.) in an accredited college or university pursuing a degree in a scientific discipline (e.g., life sciences, chemistry, biology, biotechnology, materials science, etc.)
- Minimum 3.0 GPA
- 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
- Proficient in Microsoft Office
