What is regulatory affairs in Pharmaceutical Industry
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What is regulatory affairs in Pharmaceutical Industry

What is Regulatory affairs?

Regulatory affair is a profession developed from the preference of governments to protect public health by controlling the safety and efficacy of products, and by the companies responsible for the discovery, testing, manufacture, and marketing of these products wanting to ensure that they supply products that are safe and make a beneficial contribution to public health and welfare. A new class of professionals emerged to handle these regulatory matters for companies.

In this highly regulated environment, regulatory affairs play a critical role as of the interface with health agencies and as a link between different departments in the company and as the leading department to provide strategic advice on extremely difficult decisions through the life of a drug. 

Regulatory professionals keep working with the authorities and different departments within the company to meet regulatory commitments with the health authorities. Regulatory Affairs also ensures the maintenance of the marketing license and leads life cycle extension activities such as broadening the indication of the drug, change of formulation, changes in the dosage etc.

Regulatory professionals are responsible for:

  1. Keeping track of the ever-changing legislation in all the regions in which a company wishes to distribute its products

  2. Advising on legal and scientific restraints and requirements

  3. Collecting, collating, and evaluating scientific data

  4. Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorization for the products concerned

  5. Giving strategic and technical advice at the highest level in their companies, making an important contribution both commercially and scientifically to the success of a development program and the company as a whole

  6. Helping the company avoid problems caused by badly kept records, inappropriate scientific thinking, or poor presentation of data.

Regulatory Affairs is an attractive career choice for graduate students from a scientific background who enjoy communication and teamwork, are comfortable with multi-tasking, and are eager to expand their knowledge in the wide realms of the Pharmaceutical world. Regulatory Affairs is a rewarding, intellectually stimulating, and highly regarded profession within pharmaceutical companies.