Regulatory Affairs Internship in the USA
Repligen is offering a Global Regulatory Affairs – Summer Internship based in Waltham. This internship at Repligen Careers in the USA provides a unique opportunity to work at the intersection of regulatory strategy, compliance data management, and AI-driven regulatory intelligence within the biopharmaceutical industry.
As part of Repligen’s mission to advance bioprocessing technologies that support the production of life-changing biologic drugs, the intern will contribute to building a centralized Compliance Data Hub enhanced with AI-enabled regulatory intelligence tools.
Internship Details:
- Title: Global Regulatory Affairs – Summer Intern
- Location: Waltham (US-MA)
- Job ID: 2026-5505
- Category: Quality
- Employment Type: Internship
- Compensation: $23–$26 per hour (U.S. based)
- Industry: Biopharmaceutical / Bioprocessing
About the Company:
Repligen is a global bioprocessing technology company dedicated to advancing biologic drug production. The company partners with biopharmaceutical manufacturers to deliver innovative technologies that improve efficiency, scalability, and cost-effectiveness in biologics manufacturing. Repligen fosters a collaborative and purpose-driven culture where innovation, compliance excellence, and scientific advancement are core to its success.
Educational Requirements for this Internship:
- Bachelor’s degree in Biochemistry, Biotechnology, or a related scientific/technical field.
- 0–2 years of experience (Bachelor’s level) within the biopharmaceutical industry.
- Understanding of Protein science, Chromatography, FPLC operation (desirable), and High-throughput screening techniques (desirable)
Key Responsibilities:
- Inventory and map regulatory and compliance data sources (FDA, EMA, MHRA, Health Canada, ISO standards, etc.)
- Design a centralized compliance data repository structure, including metadata and tagging frameworks, for this Regulatory Affairs Internship in the USA
- Support the development of an AI-assisted searchable compliance database in this Summer Internship
- Develop a proof-of-concept demonstrating AI capabilities to ingest regulatory updates, extract and classify regulatory requirements, map regulatory changes to impacted business areas, and generate change-impact summaries at Repligen Careers
- Draft workflows for regulatory data upload, validation, approval, and maintenance
- Provide governance recommendations (data ownership, version control, scalability)
- Deliver the final presentation to leadership outlining findings and the future roadmap in this Regulatory Affairs Internship
Skills Required:
- Strong analytical and data-structuring skills
- Excellent written and verbal communication abilities
- Ability to present technical information effectively
- Attention to detail and strong commitment to data integrity
- Problem-solving and troubleshooting mindset
- Innovative thinking with interest in AI applications
- Strong teamwork and cross-functional collaboration skills
- Ability to thrive in a fast-paced environment
Benefits of the Regulatory Affairs Internship:
- Competitive hourly pay ($23–$26/hr)
- Eligibility for variable cash programs (bonus/commission)
- Potential equity participation (eligible roles)
- Paid time off
- Health, dental, and vision coverage
- Retirement benefits
- Flexible Spending Accounts (FSA)
- Hands-on exposure to regulatory strategy and AI-driven compliance systems
- Opportunity to present directly to leadership
