Global Regulatory Pathways Drugs and Biologics; Adjunct Pool), Henry E. Riggs School of Ap

Global Regulatory Pathways for Drugs and Biologics (Adjunct Pool), Henry

E. Riggs School of Applied Life Sciences Position Overview

The Primary Responsibility Of The Adjunct Faculty Member Is Teaching. We Are Seeking Adjunct Instructors To Teach The Following Course At Keck Graduate Institute (KGI): REG 6140 Global Regulatory Pathways for Drugs and Biologics (Spring semester, 1.5 credits).

This course provides a comprehensive overview of regulatory requirements and pathways for the development, approval, and commercialization of drugs and biologics (including biosimilars) outside the United States. The focus will be on key global markets including the European Union, India, Japan, and the broader Asia‑Pacific region. Students will explore region‑specific regulatory frameworks such as the European Medicines Agency (EMA) centralized procedure, India's CDSCO processes, Japan’s PMDA review system, and regulatory trends in countries such as the China NMPA, South Korea MFDS, and Australia TGA.

The course will examine critical topics such as clinical trial authorization, marketing application requirements, quality and manufacturing compliance, pharmacovigilance obligations, and so‑called reliance pathways to speed market access and reduce duplication of effort. Global concurrent regulatory submissions are now no longer just a want, but an imperative business need. Emphasis will be placed on strategic considerations for global development programs, including multi‑regional clinical trials, harmonization efforts through ICH guidelines and differences that can impact timelines, costs, and market access.

Designed for students and professionals entering regulatory affairs or global drug development, this course equips learners with the foundational knowledge to navigate and manage regulatory activities in major ex‑U.S. jurisdictions.

A minimum of a master’s degree in a related field is required, with a doctoral degree strongly preferred. Candidates should have at least two years of teaching experience, and prior experience with active learning methods is desirable. Experience with the Canvas learning management system is preferred.

• Provides high‑quality student instruction
• Evaluates student performance (e.g., written assignments, examinations, in‑class activities);
• Provides remedial instruction as needed
• Other duties as assigned.

• Demonstrated ability to work effectively as a member of a team and collaboratively with other departments.
• Excellent interpersonal and communication skills, including the ability to effectively communicate, both verbally and in writing; possess the ability to listen to all points of view, build consensus, and inform others of policies and decisions.
• Demonstrated ability to analyze and present complex issues to diverse individuals and groups.
• Demonstrated ability to manage multiple tasks and adapt to changing priorities.

This is a part‑time, exempt, adjunct faculty position and is not eligible for benefits. Schedules will vary depending on course assignments and the needs of the department or the Institute. The base salary range for this position is $2,500 - $15,000 per semester depending on credits per course.

Ability to maintain good concentration level while dealing with interruptions; attention to details with emphasis on accuracy; capable of giving, receiving, and analyzing information, formulating work plans, and articulating goals and action plans. Sitting in a normal seated position for extended periods of time. Standing for extended periods of time. Reaching and extending hand(s) or arm(s) in any direction. Finger dexterity required to manipulate objects with fingers rather than the whole hand(s), or arm(s), for example, using a keyboard.

Communication skills using the spoken word. Ability to see within normal parameters. Ability to hear within normal parameters. Ability to bend and stoop, for example, to file. Ability to move about. Ability to lift and carry short distances up to 20 lbs., for…