Job Description

Job Title: Intern – Regulatory Affairs, CMC

Location: Remote – Montgomery, AL

Duration: June 2, 2025 – May 29, 2026

Job Description:

We are seeking a highly motivated and detail-oriented intern to join the Regulatory CMC team supporting small molecule programs. This internship offers hands-on experience with regulatory submissions, document preparation, and regulatory systems, providing a strong foundation in the drug development process and global regulatory affairs.

Key Responsibilities:

• Assist in maintaining CMC data in regulatory information management systems
• Support creation and tracking of CMC submission content and health authority correspondence
• Contribute to internal process improvements and document management
• Draft CTD CMC sections for global submissions
• Collaborate cross-functionally with QA, Supply Chain, CMC, and IT

Qualifications:

• Currently enrolled in a Graduate or Ph.D. program in a scientific discipline (e.g., life sciences, chemistry, biotechnology)
• Minimum GPA of 3.0
• Strong written and verbal communication skills
• Proficient in Microsoft Office; able to work remotely with collaboration tools
• Highly organized, adaptable, and eager to learn in a cross-functional, regulated environment

This is a paid internship designed to offer valuable industry experience in Regulatory Affairs CMC, with exposure to global regulatory strategy and biotech operations.

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