Home / Courses / Clinical Research, RA & Medical Writing
Advanced Diploma · Regulatory Affairs

Advanced Diploma in Clinical Research, Regulatory Affairs & Medical Writing

Clinical research, regulatory affairs and medical writing: from GCP and CTD/eCTD dossiers to scientific documentation.

3–6 Months Live, Mentor-Led
Advanced Diploma in Clinical Research, Regulatory Affairs & Medical Writing
What You Will Learn

Key learning areas

01Clinical Research
02Regulatory Affairs
03CTD/eCTD
04Medical Writing
05GCP
06Scientific Documentation
07AI-Assisted Workflows
08Career Preparation
Tools & Standards

Tools you’ll work with

ICH-GCPCTD / eCTDRegulatory guidelinesAI-assisted writing tools
Eligibility

Who it is for

Open to graduates and professionals from the following backgrounds:

B.Pharm & M.Pharm Graduates
Pharm.D Graduate
B.Sc / M.Sc Life Sciences Graduate
Biotechnology & Microbiology Graduates
MBBS, BDS, BHMS, BAMS Graduates
Healthcare Professionals
Format & Duration

How the program runs

Live, mentor-led classes, recorded sessions for revision, structured learning resources, hands-on projects, mock interviews and placement assistance.

1LearnLive, mentor-ledclasses2PractiseHands-onprojects3ReviseRecordedsessions4PrepareMock interviews &placement assistance
  1. LearnLive, mentor-led classes
  2. PractiseHands-on projects
  3. ReviseRecorded sessions
  4. PrepareMock interviews & placement assistance
Duration: 3–6 months
Fee: on request
FAQ

Common questions

Are the classes live?+

Yes, taught live by mentors, with each session recorded for revision.

Is placement support provided?+

Yes. We provide career and placement assistance, including resume development, mock interviews, interview preparation, and guidance on relevant job opportunities. Placement assistance is intended to support your job search; however, employment is not guaranteed.

How much does it cost?+

Fees are shared on request by our admissions team.

Related Reading

Learn more on the Healthcare Industry Bridge

Clinical research career in India: eligibility, roles and skills
ICH E6(R3) GCP explained: key changes for clinical research teams
Decentralized clinical trials: FDA guidance and ICH E6(R3) Annex 2
CDSCO joins IMDRF: what it means for regulatory affairs careers
Browse all clinical research & life sciences articles

Career Readiness

Assess your knowledge & prepare for interviews

Learners work closely with trainers to assess their understanding of core concepts and identify improvement areas. Through structured evaluations, mock interviews and guided practice, they strengthen technical clarity, communication skills and the confidence to perform in technical and HR interviews.

Knowledge Assessment Sessions
Confidence Building Sessions
Technical Mock Preparation
Weekly Evaluation & Scorecard
Non-technical Mock Preparation
Concept Revision Sessions
Articulation Skill Training
Key Support
Identify knowledge gapsHR-style mock interviewRecap of core conceptsTargeted interview prepSoft-skill evaluationPersonalised feedbackRole-play interview exercisesRole & industry-based question drillsContinuous performance monitoring

Weekly Scorecard

Sample learner progress view
Core Concepts85%
Technical Mock72%
Communication78%
HR Readiness66%
Interview-ready
Tracked every week
Program Benefits

Everything you need to move into industry

Every component is built with one goal — to guide, support and uplift you at every stage, from your first class to your first job.

Expert Career Guidance
Live Mentor-Led Classes
Hands-on Projects
Industry Expert Sessions
Mock Interviews
ATS-Friendly Resume
Placement Assistance
Curated Job Opportunities
Cross-skilling by Domain
Collaborative Learning
Revision & Retraining Sessions
Student-centric & Employability-first
Main Features

Main features of the programs

  • Live, mentor-led classes with industry experts
  • Structured learning resources & assignments
  • High-quality, industry-aligned course content
  • Recorded sessions for revision
  • Program addresses USFDA regulations
  • ICH-GCP guidelines & Indian regulations
  • Ethical considerations & practical application
  • Assignments, case studies & projects
  • Placement support
Explore More

Related courses

All Courses

Ready to move from academia to the healthcare industry?

Book a free counselling call. A CliniXen counsellor will get back to you within one working day — on call or WhatsApp.

Admissions Open

Take The Next Step Now

Here's your chance to join CliniXen's Advanced Diploma programs. Share your details and our admissions counsellor will get in touch with you to explore further.