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, creative, and supportive learning environment.

Enjoy opportunities for career growth, 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