Clinical Data & Regulatory Affairs Expert

? Location: Bangalore (Remote)

? Employment Type: Full-time

About BioTecNika

BioTecNika is India's leading biotech career and education platform, empowering students, researchers, and life science professionals through industry-focused training and career development. As we expand our Clinical Data Management (CDM) and Regulatory Affairs programs, we are looking for an experienced Clinical Data & Regulatory Affairs Expert to design, develop, and deliver high-quality learning experiences that prepare students for successful careers in the pharmaceutical, biotechnology, clinical research, and medical device industries.

Key Responsibilities

- Develop comprehensive training materials, including presentations, assignments, quizzes, assessments, and course content for Clinical Data Management and Regulatory Affairs.
- Deliver engaging live online sessions and recorded lectures for students and working professionals.
- Create educational content such as YouTube videos, articles, eBooks, case studies, and webinar materials.
- Mentor students through hands-on projects and real-world industry scenarios.
- Conduct practical training using simulations, industry case studies, and relevant CDM tools.
- Stay updated with global regulatory guidelines, including US FDA, EMA, CDSCO, ICH, WHO, and current industry trends.
- Provide career guidance, doubt-clearing sessions, and continuous learner support.
- Evaluate student performance through assignments, quizzes, and projects, offering constructive feedback.
- Collaborate with internal teams to continuously improve course quality and learner experience.

Required Qualifications

- Master's degree or Ph.D.



in Clinical Data Management, Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline.
- Minimum 2 years of core industry experience in Clinical Data Management and Regulatory Affairs within the biotechnology, pharmaceutical, medical device, or clinical research industry.
- Strong understanding of clinical trial processes, regulatory documentation, compliance requirements, ISO standards, ICH guidelines, and audit procedures.
- Hands-on experience with CDM tools such as Medidata Rave, OpenClinica, Veeva Vault, or similar platforms.
- Excellent communication, presentation, mentoring, and content development skills.
- Familiarity with online teaching platforms such as Zoom, Google Meet, and Learning Management Systems (LMS).

Preferred Qualifications

- Experience in regulatory submissions, QA/QC, audits, or drug approval processes.
- Certification in Regulatory Affairs (RAPS, DIA, IBRAS, or equivalent).
- Experience developing online courses, digital learning content, or e-learning programs.

Why Join BioTecNika?

- Be part of India's leading biotech education and career platform.
- Inspire and mentor the next generation of Clinical Data Management and Regulatory Affairs professionals.
- Collaborate with experienced industry experts and researchers.
- Work in a dynamic, innovative, and supportive learning environment.
- Enjoy opportunities for growth opportunities, professional development, and competitive compensation.
- Education: Master's Degree or Ph.D. in Clinical Data Management, Life Sciences, Pharmacy, Regulatory Affairs, or a related field.

Experience: Minimum 2 years of relevant industry experience in Clinical Data Management and Regulatory Affairs.

📌 Clinical Data & Regulatory Affairs Expert (Bengaluru)
🏢 BioTecNika
📍 Bengaluru