Biocon - Introduction to US FDA and European Laws and Regulations (Adjunct) at Keck Graduate Institute

Jeddah, Makkah Region, Saudi Arabia -

Full Time

Start Date

Immediate

Expiry Date

25 Jul, 26

Salary

15000.0

Posted On

26 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, FDA Regulations, Biopharmaceutical Industry, Drug Development, Compliance Documentation, Bioprocess Technology, Online Teaching, Canvas Learning Management System, Instructional Design, Communication Skills, Interpersonal Skills, Team Collaboration, Regulatory Submissions, Clinical Development, Post-marketing Compliance

Industry

Description

Job Posting Title: Biocon - Introduction to US FDA and European Laws and Regulations (Adjunct), Henry E. Riggs School of Applied Life Sciences Job Description: Position Overview The primary responsibilities of the Adjunct Faculty member are the instruction and coordination of the Biocon Introduction to US FDA and European Laws and Regulations course for the Henry E. Riggs School of Applied Life Sciences. The Biocon-KGI program is a program in partnership with an Indian Biopharmaceutical company which has global presence in the areas of diabetes, cancer and autoimmune diseases. This program helps train recent college graduates in various areas of Drug Development, thereby making them ready to step into industry jobs. Candidates will be expected to have a strong commitment to innovative teaching and active learning. The adjunct faculty appointment is on a term-by-term basis and the course is taught via online synchronous live sessions, which take place on weekday evenings (Pacific Standard Time). The course will be taught in the spring. Course Description: This course will provide students with broad general competencies in regulatory affairs for all FDA-regulated product classes (drugs, biologics and devices) throughout the product lifecycle (pre-clinical development, clinical development and post marketing). Emphasis will be placed on regulatory interactions - submissions, other communications and inspections - for each product class and for each phase of the product lifecycle. By the end of this course, the students will understand the structure and function of the FDA related to the Biopharmaceutical industry. They will be prepared for entry-level professional roles in Biopharmaceutical Regulatory through instruction in Regulatory submission requirements, product modification and process change requirements and compliance documentation requirements. Located in beautiful Claremont, California, Keck Graduate Institute is a member of the prestigious Claremont Colleges, a consortium of five undergraduate liberal arts colleges, two graduate institutions, and The Claremont Colleges Services, which provide shared institutional support services. Education and Experience The successful candidate will meet the following criteria: A minimum of a Master’s degree in biochemical engineering, bioengineering, or a related field, and relevant Biopharma/Biotech industry experience (5-7 years), is required. A doctoral degree is strongly preferred. Experience with downstream bioprocess technology is required. Prior teaching experience and a commitment to active learning is preferred. Experience with the Canvas learning management system and online teaching is a plus (training is available). Essential Functions and Responsibilities Individuals must possess knowledge, skills, and abilities to perform the essential functions of the position, or be able to explain or demonstrate how the essential functions may be performed, with or without, reasonable accommodations, using some other combination of skills and abilities. Provides high-quality student instruction. Evaluates student performance (e.g., written assignments, examinations, in-class activities); Provides remedial instruction as needed Required Knowledge, Skills, and Abilities Individuals must possess knowledge, skills, and abilities to successfully perform the essential functions of the position, or be able to explain or demonstrate how the essential functions may be performed, with or without, reasonable accommodations, using some other combination of skills and abilities. 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 manage multiple tasks and adapt to changing priorities. Hours, Classification, and Status: 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. Physical and Mental Requirements Ability to maintain good concentration 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. Ability to hear within normal parameters. Ability to bend and stoop (e.g., to file). Ability to move about. Ability to lift and carry short distances up to 20 lbs. (e.g., to lift or move office supplies, files, books, and packages). Ability to travel locally, depending on business needs. To Apply: A confidential review of applications, nominations, and expressions of interest will begin immediately and will continue until an appointment is made. To be ensured full consideration, please upload a letter of interest, resume, and three professional references (a manager, a direct report, if applicable, and a coworker). Equal Employment Opportunity Policy: Keck Graduate Institute is an equal opportunity employer. It does not discriminate against qualified employees or applicants based on race, color, religion, sex, gender identity, pregnancy, national origin, ancestry, citizenship status, age, marital status, physical disability, mental disability, medical condition, sexual orientation, military or veteran status, genetic information, or any other characteristic protected by applicable state or federal law. Equal employment opportunity will be extended to all persons in all terms and conditions of employment. Keck Graduate Institute (KGI) is a participating employer in E-Verify. We use E-Verify to confirm the employment eligibility of all newly hired employees as required by federal law. For more information about E-Verify, please visit www.e-verify.gov. Keck Graduate Institute, a member of The Claremont Colleges, is a graduate institution dedicated to advancing human health through innovative education, applied research, and meaningful industry collaboration. Since its founding in 1997, KGI has built a strong reputation for preparing thoughtful, forward-thinking leaders equipped to address the evolving challenges of healthcare and the life sciences. KGI’s academic programs are housed within three distinctive schools: the Henry E. Riggs School of Applied Life Sciences, the School of Pharmacy, and the School of Health Sciences. The Henry E. Riggs School of Applied Life Sciences prepares graduate students for careers in life sciences and biotechnology through interdisciplinary learning, research engagement, and real-world problem solving. The School of Pharmacy prepares future pharmacists and pharmacy leaders through a rigorous, patient-centered curriculum grounded in clinical excellence and hands-on practice. The School of Health Sciences offers graduate programs in occupational therapy, physician associate studies, and genetic counseling, with a strong focus on collaboration, leadership, innovation, and patient-centered care. Across all programs, KGI emphasizes applied learning, critical thinking, and collaboration. Students gain practical experience through lab work, research projects, clinical placements, and partnerships with industry and community organizations. This approach ensures graduates leave KGI not only academically prepared, but also adaptable, confident, and ready to contribute from day one. At KGI, our people are at the heart of everything we do. Our culture is supportive, collaborative, and people centered. Faculty and staff work together in a close-knit environment where ideas are welcomed, contributions are valued, and professional growth is encouraged. Every role plays a vital part in shaping the student experience and advancing meaningful solutions that improve lives. Joining KGI means becoming part of a purpose-driven community where your work truly matters. If you are looking for a place where your talents can make a difference, Keck Graduate Institute offers a dynamic and fulfilling environment to grow your career and make a lasting impact.

Responsibilities

The adjunct faculty member is responsible for the instruction and coordination of the Biocon Introduction to US FDA and European Laws and Regulations course. They will evaluate student performance and provide remedial instruction as needed through online synchronous sessions.