Job Title: Trainer – Clinical Data Management & Regulatory Affairs Trainer

Location: Bangalore (Remote)

Employment Type: Full-time / Part-time

About Biotecnika

Biotecnika is India's largest biotech career and education platform, dedicated to empowering students, researchers, and professionals in the life sciences domain. With 19+ years of expertise, we provide cutting-edge courses, industry collaborations, and hands-on training to help aspiring biotech professionals succeed. We are now expanding our offerings by launching a Clinical Data Management (CDM) and Regulatory Affairs course, and are looking for an experienced Trainer to lead this initiative.

Role Overview:

We are seeking a dynamic Clinical Data Management & Regulatory Affairs professional to develop and deliver training programs for students and professionals. The trainer will be responsible not just for teaching, but also for designing complete course curricula, delivering interactive classes, and creating engaging learning materials. The goal is to prepare students for real-world industry rolesinClinical Data Management and Regulatory affairs, with a strong understanding of regulatory and compliance frameworks.

Key Responsibilities: 

• Develop and update comprehensive course content, including PowerPoint presentations, assessments, interactive quiz and assignments for biotech, pharmaceuticals, medical devices, clinical research and chemical industries and ensure the course aligns with current industry standards and best practices.
• Deliver interactive online classes and engaging recorded sessions on regulatory affairs & CDM  to students and professionals.
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• Create content for YouTube shorts &  videos, reference articles, reading material,  eBooks, and participate in webinars and workshops as required.
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• Mentor students during project work and guide them in applying regulatory and  CDM  knowledge to real-life scenarios. 

• Stay updated with industry trends, tools  (e.g., Medidata Rave, OpenClinica, Veeva Vault, AI tools), and global regulatory guidelines (US FDA, EMA, CDSCO, ICH, WHO, etc.). 

• Provide virtual hands-on training using simulations, case studies, and freely available tools/templates relevant to CDM  & regulatory affairs ensuring hands-on learning and real-world exposure.
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• Collaborate with internal teams for continuous improvement in training delivery and content quality.
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• Mentor students on career pathways in Regulatory Affairs & CDM.

• Provide support through doubt-clearing sessions and career guidance.

• Assess student performance through quizzes, projects, and exams, and provide constructive feedback.

Qualifications & Experience: 

Essential:

• Master's degree or Ph.D. in Clinical Data Management, Life Sciences, Pharmacy, or Regulatory Affairs.
• Minimum 2 years of core industry experience in Clinical Data Management and in regulatory affairs in biotech, pharmaceuticals, or medical devices.
• Proficiency in CDM tools and a thorough understanding of clinical trial processes and regulatory requirements.
• Explain core concepts such as Medical devices documentation and submission, ISO standards, ICH guidelines, documentation practices, and audit processes. 
• Prior teaching/training experience in regulatory affairs, CDM   or related fields.
• Ability to simplify and explain complex concepts in a learner-friendly manner.
•  Excellent communication, presentation, and mentoring skills.
• Familiarity with MS Office and online teaching platforms (Zoom, Google Meet, LMS tools, etc.).

Desirable:

• Industry experience in CDM &  QA/QC, regulatory submissions, audits, or drug approval processes.
• Certification in Regulatory Affairs from recognized bodies (e.g., RAPS, IBRAS, DIA).
• Experience in developing online courses or e-learning platforms.

Why Work at Biotecnika

• Be a Leader in Biotech Education – Shape the next generation of regulatory professionals.
• Work with Experts – Collaborate with leading biotech professionals and researchers.
• Career Growth – Opportunities to advance in training, research, and consulting.
• Innovative Learning Environment – Access to cutting-edge tools and resources.
• Work-Life Balance – 5-day workweek, competitive salary, and a supportive team.