Drug Regulatory Affairs

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Regulatory Affairs is a comparatively new profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including Pharmaceuticals, Veterinary Medicines, Medical Devices, Pesticides, Agrochemicals, Cosmetics and Complementary Medicines. Most companies, whether they are major multinational Pharmaceutical Corporations or Small, Innovative Biotechnology Companies, have specialist departments of Regulatory Affairs professionals. The Regulatory Affairs professional’s job is to keep track of the ever-changing legislation in all the regions in which the company wishes to distribute its products. With the aim of providing training IBRI has launched the course in Regulatory Affairs with the mission to train students and professionals who can help the industry to work under regulatory environment.




Career Opportunities
A career in Regulatory Affairs is both a challenging and highly rewarding career. It opens up lot of opportunities as it covers a variety of disciplines. Individuals who are directly involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, Pharmacovigilance and others are considered regulatory professionals. The pharmaceutical
industry is growing at a rapid pace and there is a rising concern over the safety and efficacy of pharmaceutical and medical device products.

Type of companies hiring RA professional

Pharmaceutical
Medical Devices
In Vitro Diagnostics
Biologics and Biotechnology
Veterinary Products
Cosmetics
Local FDA/ US FDA/UK MHRA/EDQM
Ministry of Health/DCGI
Clinical Research Organization/ Contract Research Organization
Pharmaceutical consultancy companies

RA professional can get employment as

Regulatory Affairs Associates
Regulatory Affairs Assistance
Regulatory Affairs head/ Director
Medical Information Associates
Drug Inspector/Drug Controller/
Drug Safety Specialist/ Regulatory Food Safety Scientist
Quality Operations/Quality Control/Quality Assurance
Regulatory Affairs Consultants

Published in: Education, Business

Drug Regulatory Affairs

  1. 1. (Department of Applied Pharmaceuticals)IBRI NOIDA
  2. 2.  Growth in Indian Pharmaceuticals. Job avenues in current. Number of companies in Pharmaceutical.IBRI NOIDA
  3. 3.  A regular student of Pharmacy B.Pharma, M.Pharma. A working professional in Pharmaceutical Industry. Research scholars in the same domain.IBRI NOIDA
  4. 4.  12 months comprehensive course in distance modelearning pattern. 6 months advanced course in distance mode learningonly for working professionals. 3 months certificate course for beginners.IBRI NOIDA
  5. 5.  Most updated course material Course material prepared by highly experiencedprofessional. Effective learning process. Excellent Support Department for best service. Industry Recognized Course. Coast effective.IBRI NOIDA
  6. 6.  Course contains 7 Papers as Paper-I: Introduction to Regulatory Affairs and Profession Paper-II: International Licensing and Drug Regulatory Affairs Paper-III: Regulatory Documentation for Biologics /MedicalDiagnostics and Pharmaceutics (Submission of DMF, Dossiers etc.) Paper-IV: Global Regulatory Compliance Systems Paper-V: Regulations for Clinical Trials, GMP, GLP and ICHGuidelines Paper-VI: Regulatory Strategy and Quality Assurance Systems Paper-VII: Future of BiopharmaceuticalsIBRI NOIDA
  7. 7.  Download Registration Form Fill it completely Attach your 10th and graduation mark sheetphotocopies self attested. Course fee can be paid by Demand Draft / At parCheque. DD or At par Cheque must be in favor of “IndianBiosciences and Research Institute”. Attach all with registration form and send it to instituteaddressIBRI NOIDA
  8. 8.  Complete Study Material will be dispatched to yourmailing address. Bimonthly assignments for self assessment. Contact classes on the demand to clear doubts. Weekly conversation with faculty members. Examination and assessment. Successful candidates will received Certificate andmark sheet.IBRI NOIDA
  9. 9.  Regulatory Affairs is a comparatively new profession which has developedfrom the desire of Governments to protect public health, by controlling thesafety and efficacy of products in areas includingpharmaceuticals, veterinary medicines, medicaldevices, pesticides, agrochemicals, cosmetics and complementarymedicines. The Regulatory Affairs professional’s job is to keep track of the ever-changing legislation in all the regions in which the company wishes todistribute its products. With the aim of providing training IBRI haslaunched the course in Regulatory affairs with the mission to train studentsand professionals who can help the industry to work under regulatoryenvironment.IBRI NOIDA
  10. 10.  TO KNOW MORE Click Here ! Indian Biosciences and Research InstituteC 50, Sector 2, NOIDA 201301IBRI NOIDA

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