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Ever since the field of pharmaceutical drug development, manufacturing and marketing became regulated by regulatory agencies such as the US FDA, EMEA, and MHRA, etc. The area of Regulatory Affairs has opened up new opportunities of employment. 

The growth of the clinical research industry has pushed this demand for skilled regulatory affairs professionals even further. Regulatory Affairs careers in clinical research are very satisfying and exciting as the regulatory function is vital in making safe and effective healthcare products available worldwide. 

Roles and responsibilities of regulatory professionals often begin in the research and development phases for each product and continue throughout the product life cycle. Regulatory Affairs professionals keep themselves updated with global and local regulatory policies, procedures, and trends. They also maintain an understanding of the scientific and technical background of healthcare products. 

The Regulatory Affairs department adds great value to drug development worldwide by comprehending and interpreting the regulatory environment and suggesting pathways for reducing the time to market.

Some major responsibilities of professionals working in regulatory affairs departments are:

  • Formulating a drug development strategies
  • Providing regulatory consultation
  • Conducting gap analysis
  • Developing product dossiers and their submission to applicable regulatory agencies
  • Communicating with regulatory agencies
  • Providing regulatory affairs related training to applicable team members and/or departments


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