Pharmaceutical Management & Regulatory Affairs
An important part of the organizational structure of
Internally it liaises at the interphase of drug
development, manufacturing, marketing and clinical
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
Regulatory Affairs contributes both at early premarketing stages and at all times post-marketing.
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
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.
Remain in contact with almost every discipline within
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
They are central to the business and has the opportunity
to interact with a wide range of specialities and extend
his or her knowledge
Ability to tackle data in a wide range of scientific
Quickly grasp new concepts and complex technical
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