Global Regulatory Affairs - Summer Intern

Repligen Corporation • Waltham, MA

2d • $23 - $26 • Onsite

About The Position

Make a global impact—join Repligen. We’re united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in shaping some of the most innovative and life-changing therapies in the world. We foster a culture of purpose, collaboration, and shared success—where every voice matters and every contribution drives progress. Join us! Repligen is seeking a Global Regulatory Affairs Intern to support the development of a centralized Compliance Data Hub enhanced with AI-enabled regulatory intelligence. This internship will focus on consolidating fragmented compliance and regulatory information into a unified, searchable structure that improves efficiency, compliance readiness, and responsiveness to global regulatory change. Based in Waltham, MA , the intern will work closely with the Global Regulatory Affairs team and gain hands-on experience at the intersection of regulatory strategy, data architecture, and emerging AI applications.

Requirements

• Bachelor’s degree Chemical Engineering, Biochemistry, Biotechnology, or related field
• Minimum of 0-2 years (Bachelor’s) of experience within the biopharmaceutical industry.
• Excellent verbal and written communication skills, with the ability to effectively present technical information and collaborate across disciplines.
• Detail-oriented with a commitment to data integrity, transparency, and collaborative approaches to problem solving.
• Team player who thrives in a collaborative and fast-paced environment.

Nice To Haves

• Understanding of protein science, chromatography; experience with FPLC operation and high throughput screening techniques are desirable
• Innovative thinker with a passion for advancing biopharmaceutical technologies.

Responsibilities

• Inventory and map internal and external regulatory and compliance data sources, including regulatory requirements, standards, policies, audit observations, and jurisdiction-specific obligations.
• Design a proposed structure for a centralized compliance data repository, including metadata models and tagging frameworks (e.g., regulatory domain, geography, product relevance).
• Support the development of an AI-assisted, searchable compliance database concept that enables efficient retrieval and interpretation of regulatory information.
• Develop a proof-of-concept demonstrating how AI can:
• Ingest regulatory updates from public sources (e.g., FDA, EMA, MHRA, Health Canada, ISO standards)
• Extract and classify key regulatory requirements
• Map regulatory changes to impacted business areas
• Generate high-level change-impact summaries
• Draft proposed workflows for how Regulatory and Quality teams upload, review, validate, approve, and maintain compliance information.0
• Provide recommendations related to governance, data ownership, version control, and long-term scalability of the compliance hub.
• Prepare and deliver a final presentation to leadership summarizing findings, demonstrating the prototype, and outlining a roadmap for future implementation.

Benefits

• We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts.
• All compensation and benefits information will be confirmed in writing at the time of offer.

What This Job Offers

• Career Level: Intern