United States Department of Education in an evidence based meta-analysis of various studies conducted over a period of 12 years concluded that students who acquired higher education through online mode performed much better than those in regular class room courses. (www.ed.gov/about/offices/list/ opepd/ppss/reports.html)

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Careers in Regulatory Affairs

With the fast growth of clinical research industry there is a tremendous need of experienced regulatory professionals to work in the regulatory affairs departments of drug development companies from development to market and beyond. The role of a regulatory professional is to provide strategic regulatory advices and possess the ability to liaise at all levels to form new client relationships and develop existing ones. This is a new and exciting field, in which you will be able to expand your existing skills in a variety of different areas. Following are some main responsibilities of regulatory affairs professionals:

  • Provide regulatory support for assigned clinical research projects by interacting with various departments/ teams to ensure filing of required regulatory documents on schedule as per regulatory norms
  • Design regulatory deliverables and submit documents to regulatory authorities
  • Keep up to date knowledge of global regulatory development and provide support to existing and emerging market
  • Assist and guide subordinates in the team to interact with customers and partners
  • Interact with regulatory authorities by acting as a single point of contact in order to respond to regulatory authority comments
  • Ensuring proper training is provided to the team members and Good Regulatory Practices are followed within the team
  • Preparation of registration dossiers for regulatory submission in regulated markets

  • Education:

    - Master's or Bachelor's degree preferably in Life Sciences
    - Excellent knowledge of ICH GCP and regulatory guidelines
    - Proven experience in the preparation of regulatory submissions
    - Good understanding of worldwide regulatory legislation, guidelines and customer practice

    Skills:

    - Customer focus
    - Well developed organizational and management skills
    - Ability to work as part of a team and as an individual
    - Demonstrate management skills and ability to meet timelines
    - Dedicated with strong sense of responsibility
    - Should be abreast with industry trends and compliance
    - Excellent verbal and written communication skills

    Which Course/Program should I choose if I want to become a Regulatory Affairs Professional in Clinical Research?

    Program recommended if you wish to become a Regulatory Affairs Professional in Clinical Research is:


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