Top Regulatory Affairs Courses Details:

TechnoBridge provides best Regulatory Affairs Course with 100% placement assistance in Pune. The syllabus of the course is designed & developed by experienced industry experts as per the ongoing needs and regulations of clinical research. TechnoBridge gives 100 % job assistance to the candidates. Students get many opportunities for jobs as well as a business once they complete their Certification Course Successfully. TechnoBridge is the Best Regulatory Affairs Training institute in Pune That covers all the essentials as per the standard guidelines. It includes the Drug Development, Introduction to GCP, Introduction to Regulatory Affairs, Regulatory Bodies (FDA, CDSCO), Application and Approvals (Drug and Device), Quality Assurance in RA, Design of trials, Privacy and Confidentiality, and Safety Reporting.

Best Certification Course for Working Professionals & Job Seekers

TechnoBridge offers Expert Designed Drug Regulatory Affairs Course for Professionals & Job Seekers. All our candidates pursue this training programs for different reasons. For professionals, it is an add-on to their existing skillset. CRO owners can use these skills to enhance their business. Whereas these skills help job seekers get a job. Therefore, our courses are structured to meet the needs of different students.

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How to Enroll?

Online Application:

Candidates can easily apply directly on our website for Online Regulatory Affairs course with 100% placement assistance. Our team will receive your application and help you with further processes. Additionally, Candidates can directly call our admission officers on the official contact number +91-9257035703.

Course Fees:

Our Regulatory Affairs Course Fee is 27000/- for one time payment & 32000/- for installment.

RA Course Key Features

  • Learn From Corporate Experts / Faculty
  • 100% Placement assistance
  • Best and Affordable Price
  • Life Time Access to The Course
  • Detailed Curriculum
  • Mock Interviews
  • Flexible Batch Timings
  • Trained 25000+ Students
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Regulatory Affairs Syllabus [Updated 2024]

Introduction to Clinical Research
  • Introduction to Clinical Research
  • Terminologies in Clinical Research
  • Advantages of CR in India
  • Introduction to Clinical Research- Notes
  • Introduction to Clinical Research Quiz
Good Clinical Practice (GCP)-ICH E6
  • History Development of International Regulations in Clinical Research
  • Good Clinical Practices
  • Ethics committee
  • Investigator Responsibilities
  • Sponsor Responsibilities
  • Protocol and Investigator Brochure
  • Essential Documents
Safety Reporting
  • Adverse Event Reporting
  • Recording of Event
  • Medical Management of Adverse Events
  • Handling Death
  • Unblinding of Drug
  • Clinical Safety and Pharmacovigilance
Application, Approval And Quality Assurance in RA
  • Application of Permission
  • Approval of Clinical Trial
  • Purpose of QA
  • Responsibility of Quality Function
  • Medical Devices
Drug Development Process
  • Overview of Drug Development
  • Clinical trial phases
  • BA/BE Studies
  • Drug Development Notes
  • Drug Development Quiz
Design of Trials
  • Introduction Medical Writting 1
  • Drafting a study protocol
  • CRF Design
  • Study Design
  • Informed Consent
  • Trial Master File
Introduction to RA And Regulatory Bodies
  • Introduction to Regulatory Affairs
  • International Regulations and Initiatives
  • FDA – Food & Drug Administration
  • FDA- An Introduction
  • CFR
  • CT_Rules_2019
  • ICMR Guidelines
Privacy and Confidentiality
  • Privacy and Confidentiality
  • Informed Consent Privecy
  • IRB's Role in Protecting Privacy
  • Data Protection

Why Choose TechnoBridge?

In our certification program at TechnoBridge you’ll get the opportunity to

  • Learn From Corporate Experts:

    Study from experienced professionals of 25+ years of expert involvement with the business and rank among the most achieved in the worldwide regulatory affairs market.

  • Best and Affordable Price:

    Keep awake to date on advancing worldwide regulatory systems and industry patterns through ALERT, a worth add a program for understudies and graduated class, which highlights speakers from a scope of regulatory enterprises and furthermore gives professional advancement administrations to understudies at all phases of their vocations.

  • 100% Placement Assistance

    Associate with our Training & placement that works at the world's biggest drug, biologic, clinical gadget, nutraceutical, and cosmeceutical item and administration.

  • Life Time Access to The Course:

    This is the one time pay and lifetime accessable course. The course will enable students to create regulatory documents and develop content for regulatory documents.

Regulatory Affairs Salary & Certification :

The job salary varies from profile to profile. An average salary package after completing the Regulatory Affairs course is 1.8L to 4.8L annually.

TechnoBridge provides a certificate after completing this course successfully. Students must have 90% attendance along with good results in the exam.


What are Future Career Opportunities In Regulatory Affairs in India

Clinical research is the approach to propelling information about wellbeing, sickness, and medical care. There are different sorts of contemporary profession choices which you will get in this field. The clinical business is filling dramatically in India and the development will be increment ever later. A few positions in Clinical research are rattled off beneath. We provide highly challenging and rewarding careers in -

  • Regulatory Affairs Executive
  • RDrug egulatory Affairs Associate (CRA)
  • Regulatory Affairs Consultant
  • Drug safety or food safety officer
  • Medical & Regulatory officer
  • Quality Assurance Executive RA
  • Medical Coding
  • Medical writer
  • Drug Inspector
  • Manager –Safety / Patents
  • Data Analyst Pharmacovigilance
  • Clinical Trial/ regulatory Assistant (CTA)
  • Medical Information Associate
  • Project manager
  • Clinical trial writer

Benefits of our Regulatory Affairs Courses

In this Certification program at TechnoBridge you’ll get the opportunity to:

The Regulatory Affairs Programme at TechnoBridge have the following enticing elements which clearly help the students of the course

Expansive data, obviously focusing on the medical services industry

Effectively organized course, cleverly set up under the direction of industry specialists from the same field

Easily accessible simple to use, peruse and investigate e-tools woven astoundingly into the course make the review material, addresses, online data set, assessments, modules, and test papers.

Start Regulatory Affairs Career in Below Sectors:

Yes, the Regulatory Affairs industry is definitely booming and growing at an exponential rate. Nonetheless, one should know the respective sectors in this industry. Listed below are the sectors you can work after completing this course:

  • Pharmaceutical Companies
  • Biotechnology Company
  • Clinical Data Management Companies
  • Pharmacovigilance Centers
  • IT Companies in Healthcare
  • Clinical CRO(Contract Research Organization)
  • Data Management CROs
  • Packaging Labeling and Contract Manufacturers

Companies and Clients for Regulatory Affairs:

Candidates who have completed Regulatory Affairs OR Pharmacovigilance Courses will be place in the following sectors:

  • Sciformix
  • TCS
  • Cognizant
  • Springer Nature
  • Cotivity
  • Lupin
  • Docplexus
  • 3Gen Consultancy
  • Augustus
  • Accutest
  • Iqvia
  • Access Healthcare
  • Emcure Pharmaceuticals

Our Placement Process

Eligibility Criteria

Placement Training

Interview Q & A

Resume Preparation

Aptitude Test

Mock Interviews

Scheduling Interviews

Job Placements

Course Review

Anuva S.
Online Clinical Research Course
"This was definitely an ample decision for me to complete successfully this online clinical research course during the lock will definitely help me a lot to fix my adds a crown on my career.there was a proper syllabus and the ppt is really helpful for ever..the instructor and the adminstrative part are also very good..their supervision really helped me a lot.thank you😊."
Nisha M.
Online Clinical Research Course
"Technobridge’s digital marketing courses are the best because trainers give you a sneak-peek of a digital marketer’s daily routine. Students are given a variety of live projects during their training. Furthermore, the industry experts give you constant feedback after evaluations and assessments. After the course, I got a job with an attractive package. Thank you Technobridge."
Nikhil k.
Online Clinical Research Course
"Pursing a clinical research course from Technobridge was the best decision I made in life. The course is inclusive of technical knowledge, soft skills and English sessions. Trainers give students case studies and live projects, thus making it a practical and job oriented training. Also, one gets feedback regularly as the trainers conduct regular assessments. Another thing is that you can also pay a certain percentage of the fees after getting a job. I got placed promptly after my course was done. A big thank you to everyone at TechnoBridge."
Divya B.
Online Clinical Research Course
"Good experience.... I like this system because they provide all required practical / technical skills for job to place the candidates."
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Frequently Asked questions

1. What is Regulatory Affairs?

Regulatory Affairs is a branch of clinical research that has great opportunities for a career. There are different periods of clinical research from the production of the medication. This course open numerous career opportunities for clinical research experts at various stages of drug development unlimited professions. RA researchers are engaged with supervising the most common way of helping medication or items through the FDA survey and endorsement process and onto the market. Since each progression during the time spent item advancement is exceptionally directed, those in RA work at each progression to move medication from innovative work through FDA endorsement.

2. What are Regulatory Affairs in Clinical Research?

Regulatory affairs in the clinical trial are portions of the biotech channel that come after disclosure research and before the product can be utilized out on the planet along these lines, researchers in regulatory and clinical professions are significant entryways. The primary reason for this segment is to protect individuals. The researchers do this by deciding the signs, portion, and treatment populace through clinical preliminaries. RA officers do this by liaising among organizations and wellbeing specialists.

  • • PV Specialist
  • • Researcher
  • • PV/ Drug Safety Associate
  • • Team Lead
  • • Manager
  • • Data Manager
  • • Project Manager
3. Where do Candidates find Regulatory Affairs career opportunities?

Candidates who have completed Regulatory Affairs Courses will be placed in the following sectors:

  • Pharmaceutical Companies
  • Biotechnology Company
  • Clinical Data Management Companies
  • Pharmacovigilance Centers
  • IT Companies in Healthcare
  • Clinical CRO(Contract Research Organization)
  • Data Management CROs
  • Packaging Labeling and Contract Manufacturers
4. Is Regulatory Affairs Course demo Session free?

Yes, demo Session is free of cost.