Practicing Regulatory Affairs: Essential Foundations for New Professionals
School of Professional StudiesLocation: Hybrid | Length: 5 Weeks | Program Start Date: September 28, 2026
Step into the world of regulatory affairs and build the skills needed to launch or transition into a career in this growing field. This hands-on short course introduces the core foundations of regulatory practice—from product classification and approval pathways to safety oversight and promotional compliance.
Through interactive online learning and a culminating in-person experience, you’ll gain practical insight into how regulatory professionals support product development, communicate with authorities, and guide organizations through complex regulatory decisions.
Program Details
Program Length: 5 Weeks
Time needed:
- One synchronous, virtual meeting over four weeks (2-3 hours per session)
- Two days in-person in Boston (8 hours per session, plus an additional 2 hour networking event)
Cost:
- MCPHS alumni: $2,650 (Please email professionalstudies@mcphs.edu for your unique discount code)
- Early-bird pricing: $2,750 (Discount code: RAEARLYBIRD26)
- List Price: $2,950
Important Dates
- October 26 - 27 – In-person in Boston, including an 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 two-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. The session also includes a networking reception featuring various leaders and professionals in the life sciences industry.
- Explain how regulatory laws, guidance, and agency expectations shape product development, approval, and compliance across the life sciences industry.
- Identify appropriate regulatory pathways and product classifications for drugs, biologics, medical devices, and combination products, and understand how those decisions influence development strategy.
- Understand the core components of regulatory submissions—including INDs, NDAs, BLAs, and device submissions—and how regulatory information is organized and communicated to health authorities.
- Connect regulatory requirements to real-world development activities, including CMC, quality systems, clinical research, and safety monitoring throughout the product lifecycle.
- Build practical regulatory communication skills, including drafting responses to health authority inquiries and identifying compliance risks in labeling, promotional materials, and post-market activities.
This course is designed for early-career professionals and career changers who want to build the foundational skills needed to enter regulatory affairs roles in the life sciences industry.
- Recent graduates in science, public health, pharmacy, or related fields
Build practical regulatory knowledge and vocabulary to position yourself for entry-level Regulatory Affairs coordinator or specialist roles. - Quality assurance, manufacturing, and operations professionals
Connect your CGMP and quality systems experience to regulatory submissions and lifecycle management while preparing to transition into regulatory or hybrid RA–QA roles. - Clinical operations professionals
Leverage your background in clinical trials and GCP to better understand how clinical data supports regulatory submissions and interactions with health authorities. - Scientists, CMC analysts, and technical or medical writers
Learn how scientific data, reports, and labeling content are translated into regulatory filings and regulatory communications. - Healthcare professionals exploring careers beyond clinical practice
Nurses, physician assistants, pharmacists, and other healthcare practitioners can apply their clinical knowledge in a regulatory or life sciences industry role. - Device engineers and quality specialists
Expand your expertise into regulatory strategy and submissions, including pathways for medical devices and combination products. - International professionals entering U.S. or EU markets
Align prior regulatory or life sciences experience with FDA and European regulatory expectations to support a smoother transition into global regulatory roles.
- Module 1: Foundations of FDA Oversight and Product Regulation
- Module 2: Evidence Standards, Development Pathways & Early FDA Interactions
- Module 3: Regulatory Pathways, Market Incentives & Expedited Options
- Module 4: Real-World Evidence and Modern Regulatory Trends
- Module 5: Applied Regulatory Practice and Compliance Readiness
- Module 6: Capstone: Regulatory Strategy Presentations Faculty
Christopher Fulmer, JD, LLM, MBA, MS, RAC (Devices)
The course is led by Christopher T. Fulmer, a regulatory affairs and compliance professional with experience spanning healthcare, pharmaceuticals, and FDA-regulated products. A former practicing attorney with more than two decades in legal practice, he now focuses on regulatory strategy, policy analysis, and medical writing for life sciences organizations.