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Regulatory Affairs Profession
Regulatory Affairs Profession
Regulatory Affairs Profession
Regulatory Affairs Profession
Regulatory Affairs Profession
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Regulatory Affairs Profession

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  • 1. Manish Sharma M. Pharm. Pharmaceutical Management & Regulatory Affairs
  • 2.  An important part of the organizational structure of pharmaceutical companies.  Internally it liaises at the interphase of drug development, manufacturing, marketing and clinical research.  Externally it is the key interface between the company and the regulatory authorities.  It integrate regulatory principles and preparation and submission of the relevant regulatory dossiers to health authorities.  Regulatory Affairs contributes both at early premarketing stages and at all times post-marketing.
  • 3.  For adequate reporting of data for a timely positive evaluation of a marketing application.  For coordinating scientific effort with regulatory demands throughout the life of the product, which help to maximize the cost-effective use of the company’s resources.  It is the first point of contact between the government authorities and the company.  Regulatory Affairs professionals can advise upon and further influence the strategic decisions of companies.
  • 4.  Remain in contact with almost every discipline within the industry.  Liaise closely with every kind of specialist.  Use and assimilate information provided by such specialists, present that information to regulatory authorities and feed-back their opinions to the company and familiar about the current thinking of the regulatory bodies.  They are central to the business and has the opportunity to interact with a wide range of specialities and extend his or her knowledge
  • 5.  Ability to tackle data in a wide range of scientific areas  Quickly grasp new concepts and complex technical information  Communication skills  Ability to evaluate the strengths and weaknesses of the technical and legal options open to a company and to the regulatory agency  Project management skills  Integrity and the ability to inspire trust and confidence

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