Intern – Regulatory Affairs, CMC

This is a fully remote position, open to applicants in United States.

📋 Description

• Gain insight into the extensive field of global Regulatory Affairs, particularly within CMC Regulatory Affairs, and understand how this role aids in drug development and improves patient access to medications.

• Discover the function of global Health Authorities throughout the drug development journey.

• Acquire practical experience in the preparation of regulatory documents intended for submission to global health authorities.

• Understand the variations in regulatory requirements across different regions.

• Engage with CMC technical product development and manufacturing processes in the context of regulatory affairs.

• Responsible for ensuring the precision of CMC information within the BeOne Regulatory Information Management system.

• Conduct data remediation tasks.

• Develop and maintain CMC Submission Content.

• Upload Health Authority Correspondence, Questions, and Commitments.

• Keep internal Regulatory CMC trackers updated.

• Assist in improving Regulatory CMC processes.

• Aid in drafting CTD CMC sections to guarantee timely and high-quality global applications for direct submission to Health Authorities as required.

• Provide assistance to the Reg CMC team or hiring manager with regulatory submissions and various tasks as necessary.

⛳️ Requirements

• Currently enrolled (Graduate or Ph.D.) in an accredited college or university, pursuing a degree in a scientific field (e.g., life sciences, chemistry, biology, biotechnology, materials science, etc.) with a minimum GPA of 3.0.

• Familiarity with processes related to working in a regulated environment is preferred.

• Basic understanding of the healthcare industry and a strong enthusiasm for biotechnology.

• Legally authorized to work in the United States without requiring sponsorship for employment now or in the future.

• Capable of working independently on assignments with regular check-ins.

• Excellent written and verbal communication skills.

• Organized, responsible, resourceful, and detail-oriented.

• Able to collaborate effectively in a cross-cultural team with members from various time zones.

• Comfortable working remotely using MS TEAMS and other collaborative tools.

🏝️ Benefits

• Medical

• Dental

• Vision

• 401(k)

• FSA/HSA

• Life Insurance

• Paid Time Off

• Wellness