Understanding Regulatory Affairs: Strategic Insight for Life Sciences Teams
School of Professional StudiesLocation: Hybrid (Online and In Person) | Length: 4 weeks | Program Start Date: October 5, 2026
Regulatory affairs play a critical role in bringing life sciences products to market, yet many professionals interact with regulatory teams without fully understanding how regulatory decisions shape timelines, risk, and development strategy.
This short course provides a practical introduction to regulatory affairs for professionals whose work intersects with regulatory functions. You’ll gain a clear understanding of how regulatory requirements influence the product lifecycle and how regulatory strategy impacts key business decisions. By building regulatory fluency, you’ll be better equipped to anticipate regulatory needs, contribute to cross-functional strategy, and add greater value to your organization.
Program Details
Length: 4 weeks
Time needed:
- One synchronous, virtual meeting over three weeks (2 hours per session)
- Two-and-a-half days in-person in Boston (8 hours per session, plus an evening 2 hour networking event)
Cost:
- MCPHS alumni: $1,650 (Please email professionalstudies@mcphs.edu for your unique discount code)
- Early-bird pricing: $1,750 (Discount code: RAEARLYBIRD26)
- List Price: $1,950
Important Dates
- October 5, 2026 – October 25, 2026 – online
- October 27 (evening), October 28 and October 29 – in person in Boston, includes evening networking reception featuring professionals and leaders in the life sciences industry.
Program Roadmap
- Participate in five modules that combine online learning with an immersive in-person experience.
- Blend self-paced activities with live, synchronous sessions. Participants and faculty meet online at the same time for discussion, case analysis, and interactive exercises. This structure allows for flexibility while maintaining connection and accountability.
- Attend a three-day, in-person session in Boston with faculty and peers from across the life sciences sector, enhancing learning through live discussion, in-depth case studies, and immersive roundtables. This Boston experience also includes a networking reception featuring various leaders and professionals in the life sciences industry.
- Understand the role of Regulatory Affairs and why it matters. Learn how regulatory strategy protects patients, ensures compliance, and shapes key decisions across the life sciences industry.
- Navigate the regulatory landscape with confidence. Gain a high-level understanding of major regulators, global frameworks, and the regulatory milestones that guide product development.
- Recognize where Regulatory Affairs fits across the product lifecycle. Understand when and why regulatory teams must be involved—from early development and clinical trials through manufacturing, labeling, and post-market changes.
- Identify common cross-functional touchpoints and risks. Explore where regulatory considerations intersect with clinical research, quality, CMC, labeling, and commercial activities—and how to avoid common compliance pitfalls.
- Collaborate more effectively with regulatory teams. Build practical skills and shared language to improve cross-functional communication, reduce delays, and support more efficient product development.
This course is designed for professionals who collaborate with regulatory affairs teams and want a clearer understanding of regulatory expectations across the product lifecycle.
- Quality assurance, manufacturing, and operations leaders
Professionals responsible for quality systems, change control, and CGMP compliance who regularly partner with Regulatory Affairs on inspections, deviations, documentation practices, and manufacturing changes. - Process development and CMC scientists
Scientists generating chemistry, manufacturing, and controls (CMC) data who need to understand how technical reports, validation work, and process documentation are translated into regulatory submissions. - Clinical research professionals
Clinical research coordinators, clinical research associates (CRAs), and clinical trial managers who work with Regulatory Affairs on study protocols, regulatory filings, amendments, and trial timelines. - Supply chain and technical operations leaders
Professionals responsible for post-approval manufacturing changes, product variations, and lifecycle management who need to coordinate closely with Regulatory Affairs to avoid regulatory delays.
- Medical affairs, marketing, and commercial professionals
Professionals involved in labeling, promotional review, and scientific communications who must ensure claims and messaging align with approved product labeling and regulatory requirements. - R&D project and program managers
Program leaders responsible for coordinating cross-functional development teams who need to integrate regulatory strategy into project plans, development milestones, and submission timelines. - Early-stage biotech and MedTech leaders
Founders and senior leaders seeking a practical overview of regulatory pathways, submission processes, and agency expectations to better guide early development and first regulatory filings.
- Module 1: Regulatory Affairs and Why it Matters
- Module 2: Who Regulates What? Understanding Global Regulatory Affairs
- Module 3: Product Lifecycle at a Glance
- Module 4: Cross-Functional Alignment & Regulatory Submissions
- Module 5: Post Market & Compliance Culture
Omvir Singh, Ph.D.
Dr. Omvir Singh is a Senior Regulatory Consultant and an experienced faculty member with a background in academia, government, and the private sector. He previously served as an Assistant Professor at the University of Pittsburgh, as a Lead Reviewer at the FDA’s Center for Devices and Radiological Health, and has taught in the Regulatory Affairs program at Johns Hopkins University. He holds a Ph.D. in Microbial Biotechnology and a master’s degree in Regulatory Affairs from Johns Hopkins University.