Professional Documents
Culture Documents
6. Regulatory Bodies
Drug Regulatory Affairs
Any Guesses?
Drug Regulatory
Affairs
It is a honest and reputed profession.
Judge
(The Competent Authority)
Judge
(The Competent Authority)
Communication Gap
Management RA Legislation
Experts
Commercialization
Why Drug Regulatory Affairs?
The path of drug registration is laid down with good intention but can
be complicated.
Communicative Decisive
Diligent Authoritative
Flexible Creative
Ability to work with and respect other discipline (scientific and non-scientific)
Good IT skills
Qualities for Submission Management
Communicating
E.g. Internally – Your team, management
Externally – The assessors, experts
Controlling resources
E.g. Appropriate databank
Techno-Commercial Personality
Conclusion