Description

Job Description

General Overview

The School of Professional Studies is seeking an adjunct instructor to develop and teach a short-format course titled Regulatory Affairs Foundations for Practice. This offering is designed for early-career professionals and career-changers seeking to enter regulatory affairs (RA) roles. The course delivers practice-ready fundamentals mapped to RAC domains, including classification and pathways, submissions and eCTD, CMC/quality integration, clinical/GCP, pharmacovigilance, and promotional compliance.

Learners will apply concepts through RAC-style quizzes and lightweight simulations (e.g., mock FDA responses, labeling checklists). The course is expected to launch in 2026, with final format and delivery details still being determined. It may be offered:

• Fully in person over the course of several days, or
• In a hybrid format, combining online components with an in-person session in September 2026.

Candidates should be comfortable with either format and flexible in adapting to evolving delivery plans.

Essential Duties and Responsibilities:

• Teach an estimated 30 hours total, depending on final course format and delivery mode. This may include live instruction, asynchronous engagement, and/or in-person sessions delivered over several consecutive days.
• Deliver engaging, applied sessions covering topics such as: regulatory systems and law, product classification and pathways, CMC and quality integration, submissions and eCTD lifecycle, clinical and safety planning, and post-market compliance and health authority interactions.
• Incorporate expertise and participation from industry professionals as guest speakers or case contributors.
• Curate and/or develop course materials including: micro-lectures, case studies, discussion prompts, quizzes, scenario-based assessments, and/or downloadable resources.
• Design and administer assessments aligned with course outcomes (e.g., RAC-style MCQs, mock FDA info request, labeling checklist).
• Ensure the offering meets the high-quality standards of other MCPHS online and on-campus courses.

Identify tactics to improve the short course based on feedback from its initial delivery.

Requirements

Required

• Bachelor's degree required. Advanced degree in subject area or related field preferred.
• Experience working in regulatory affairs or in a closely related function (e.g., quality, clinical, CMC, labeling).
• Previous experience teaching and/or developing in-person training.
• Excellent oral, written, and interpersonal communication skills.
• A commitment to student success and the ability to engage and motivate students in an online format.
• Comfort with ambiguity and effective problem-solving related to launching a new initiative.

Desired

• Experience with a learning management system, such as Blackboard.

Apply
Please attach a cover letter and a curriculum vitae/resume. Finalist candidate(s) for this position will be subject to reference checks and a pre-employment background check as a condition of employment.

Applicants must be authorized to work for any employer in the U.S. MCPHS is unable to sponsor, or take over sponsorship of an employment Visa. MCPHS is also not an E-Verify institution.

About Us
Established in 1823, Massachusetts College of Pharmacy and Health Sciences (MCPHS) is the oldest institution of higher education in Boston, a city that is home to many of the world's top universities and healthcare institutions. We are one of the largest and most highly-ranked schools for health and life sciences, and our alumni and faculty continually distinguish themselves in healthcare settings around the globe. MCPHS has more than 7000 students across campuses in Boston's Longwood Medical and Academic Area (LMA), downtown Worcester, MA and downtown Manchester, NH. Our vision is to empower our Community to create a healthier, more equitable world, which we strive to achieve through our core values of integrity, community, engagement, collaboration, support, and innovation.

MCPHS is an equal opportunity employer dedicated to ensuring equal opportunity for all members of the University community. We aim to recruit, develop, and retain the most skilled faculty and staff. All qualified applicants will be considered for employment.