Global Regulatory Affairs Intern at Repligen… · Waltham

Summary: Repligen Corporation is committed to inspiring advances in bioprocessing for biologic drugs that enhance human health. The Global Regulatory Affairs Intern will support the development of a centralized Compliance Data Hub, focusing on consolidating regulatory information and enhancing compliance efficiency through 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 - Prepare and deliver a final presentation to leadership summarizing findings, demonstrating the prototype, and outlining a roadmap for future implementation Required 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 Required Skills: Biopharmaceutical industry experience, Protein science understanding, Chromatography knowledge Important Skills: FPLC operation experience, High throughput screening techniques Nice-to-Have Skills: Curiosity for troubleshooting, Innovative thinker Benefits: Paid time off, Health/dental/vision, Retirement benefits, Flexible spending accounts