Adjunct Faculty - Regulatory Affairs

• Teach an estimated 30 hours total
• 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

• 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

Experience with a learning management system, such as Blackboard