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Responsibilities of Regulatory Affairs Professionals

The regulatory department is responsible for so many things. They have to ensure manufacturers comply with global regulatory requirements.

Regulatory Affairs manages how drugs and medical devices are developed, tested, manufactured, marketed and distributed, and regulatory affairs are involved in each of these steps to certify that the product themselves and each of the steps meet regulatory standards for human use.

Responsibilities of Regulatory Affairs Professionals

Overall, the regulatory department is responsible for a lot. First, they have to ensure manufacturers are in compliance with any applicable global legislative and regulatory requirements. And these steps need to be followed at each stage of the development process, so all the way from research and development to the pre-clinical phase through the clinical phase, and then followed by marketing and post-marketing.
Along with the drug development process, there are many times where regulatory submissions are required to move on to the next phase of the drug development process. Next, regulatory affairs professional is also responsible for keeping track of all the different updated legislative not only in the countries that the company might be in but globally which means, basically, anywhere that company is looking to distribute its products.

Regulatory is also called upon for advising different legal and scientific restraints and requirements throughout the drug development process. Regulatory affairs professional is also responsible for collecting, understanding, collating and identifying scientific and clinical data. Again, that data goes to all the different regulatory submissions.

So, it’s very important for every regulatory person to understand what that data truly means. Along with that, the regulatory affairs department is also responsible for giving any strategic and technical advice to the different functional areas from a regulatory standpoint. And these functional areas can stand from medical affairs, clinical development but also into commercial marketing.

Another huge responsibility for regulatory affairs professionals is to make sure that all the records and documentation are kept correctly. A lot of submissions require annual reports to the FDA or to any other governmental agency depending on the country and to fill out these reports is very important to understand what happens throughout the year and that requires immaculate documentation.

General sub-departments that exist from company to company are as follow: 

1. Advertising and Promotion

Deals with marketing assets and makes sure that are in compliance with all regulations for all purposes.

2. Drug labeling

A whole team is required to update the label based on regulation which will be different based on which country is filing a submission for. A label needs to be in compliance with all regulations and also needs to be very scientifically sound. 

3. Chemistry, Manufacturing, Control (CMC)

This deals with understanding all of the different processes within manufacturing, chemistry and testing. This all information is required for different submissions to the regulatory agencies and it’s incredibly important to understand how to decipher, collect and relate that information to the governmental agency. 

4. Strategy

With regulatory strategies focuses on giving insight and advice on where different submissions should happen and what needs to be done to make that submission possible. Strategies behind any meetings with the FDA that would one want to make an appointment for, etc. Strategy is one of the huge parameters for the drug development process from a regulatory standpoint. 

5. Medical Writing

An expert who is responsible for writing different submissions and documentation as a writer.

Regulatory as a department can be seen as a geeky part between the company and the regulatory agency. For regulatory affairs and for any pharmaceutical company in general their main client is the FDA because if they can get through the FDA and get approval from FDA then eventually products can go to the market.