Global Regulatory Affairs - Summer Intern at Repligen

Waltham, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

26 May, 26

Salary

26.0

Posted On

25 Feb, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Compliance Data Hub Development, AI Application, Data Consolidation, Metadata Modeling, Tagging Frameworks, Regulatory Intelligence, Data Architecture, Data Ingestion, Change Impact Analysis, Workflow Drafting, Data Governance, Version Control, Scalability Planning, Technical Presentation, Troubleshooting

Industry

Biotechnology Research

Description

Overview 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. 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. Provide recommendations related to governance, data ownership, version control, and long-term scalability of the compliance hub.0 Prepare and deliver a final presentation to leadership summarizing findings, demonstrating the prototype, and outlining a roadmap for future implementation. Qualifications Bachelor’s degree Chemical Engineering, Biochemistry, Biotechnology, or related field Minimum of 0-2 years (Bachelor’s) of experience within the biopharmaceutical industry. Understanding of protein science, chromatography; experience with FPLC operation and high throughput screening techniques are desirable Excellent verbal and written communication skills, with the ability to effectively present technical information and collaborate across disciplines. Curiosity for troubleshooting and solving technical scientific challenges related to downstream processes. Detail-oriented with a commitment to data integrity, transparency, and collaborative approaches to problem solving. Innovative thinker with a passion for advancing biopharmaceutical technologies. Team player who thrives in a collaborative and fast-paced environment. What Repligen Offers Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is $23/Hr. - $26/Hr. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. 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.

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Responsibilities

The intern will support the development of a centralized Compliance Data Hub enhanced with AI, focusing on consolidating compliance and regulatory information into a unified, searchable structure. Key tasks include inventorying data sources, designing the repository structure, and developing a proof-of-concept for AI-assisted regulatory intelligence retrieval.