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Regulatory Affairs Trainer

Regulatory Affairs Trainer

BioTecNikaBengaluru, Karnataka, India
3 days ago
Job description

Role Overview :

We are seeking a dynamic Regulatory Affairs Trainer with deep expertise in biotech and life

sciences regulations to develop and deliver training programs for students and professionals.

The trainer will play a crucial role in designing course content, conducting live sessions,

mentoring learners, and ensuring high-quality industry-aligned education.

Key Responsibilities : Course Development & Delivery :

  • Develop a structured curriculum covering regulatory requirements for biotech, pharmaceuticals, medical devices, and clinical research.
  • Design and deliver engaging training sessions (live and recorded).
  • Prepare study materials, assignments, and assessments to enhance learning outcomes.
  • Stay updated with global regulatory guidelines (US FDA, EMA, CDSCO, ICH, WHO, etc.).

Student Engagement & Mentoring :

  • Conduct interactive Q&A sessions, case studies, and real-world applications.
  • Mentor students on career pathways in Regulatory Affairs & Compliance.
  • Provide support through doubt-clearing sessions and career guidance.

    • Industry Collaboration & Compliance :

  • Ensure the course aligns with current industry standards and best practices.
  • Collaborate with biotech companies and regulatory professionals to provide guest lectures and practical insights.

    • Evaluation & Feedback :

  • Assess student performance through quizzes, projects, and exams.
  • Gather feedback and continuously improve course delivery and structure.

    • Qualifications & Experience : Essential :

  • Master’s or Ph.D. in Biotechnology, Life Sciences, Pharmacy, or Regulatory Affairs.
  • 3+ years of experience in regulatory affairs, compliance, or quality assurance in biotech, pharmaceuticals, or medical devices.
  • Strong knowledge of global regulatory frameworks (FDA, EMA, CDSCO, ICH, WHO, etc.).
  • Prior teaching / training experience in regulatory affairs or related fields.
  • Excellent communication, presentation, and mentoring skills.

    • Desirable :

  • Industry experience in 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.
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    Trainer • Bengaluru, Karnataka, India