My first blog

Hey friends,

As a registered pharmacist associated with pharmaceutical industry for more than 20 years in Regulatory Affairs Function, I always wished to spread the knowledge, gained throughout my educational and professional life, with anyone and everyone who may be interested to know about this field. This is my first blog and I decided upon regulatory affairs because that's what I have been doing and that's what I love to do. The thought which came into my mind was why would anyone be interested in regulatory blog? And I thought to myself , may be because they share common goals with me...such as being associated with an ethical industry and an ethical function so as to create difference to the world by saving lives of the people. Our contributions in this function ultimately leads to timely approval of life saving drugs or devices, which according to me is a very satisfying experience in itself.

Now that I have shared the reason why I decided to blog on regulatory, next step would be to indicate upfront that all views shared through my blogs will be my independent views, based on the expertise gained over the years. The idea is to share the basic concept, needs and responsibilities of this function so that anyone who wants to pursue it as their career or even just intends to know more about this function would be able to get some guidance and way forward.

Having said that I will be sharing some important links of articles, guidance's and references wherever deemed necessary. But it will be done in moderation. Idea is not to bombard you with loads of information, which is already freely available, but instead make this entire experience an enjoyable one, while being informative enough to provide you clear understanding of any particular topic.

I intend to share some real life experiences which will come handy and serve the purpose of good case study.

I would like to emphasize on the fact that globally there is huge demand for regulatory affairs and it is one of the fastest growing and recognized function in pharmaceutical industry. Why so?  One of the reasons is that we are an important link between the industry and the regulators.

Another beautiful aspect which I personally like about  regulatory is we get to interact with almost all key functions within a pharmaceutical firm. While requesting for any product approval we have to discuss about technical, legal, patent, supply chain, covering almost all aspect associated with a product from conception to commercialization, which makes it quite an enriching experience.

Well this is just the beginning. In my future blogs I will be sharing knowledge covering various aspects related to this function. I will begin with roles and responsibility of Regulatory function, the educational, and other functional skill sets required for this job. Will also share tips on some of the soft skills required to achieve successful outcomes while dealing with regulators. Will cover the technical, legal requirements, important guidance's, rules and regulations, both general and market specific.

Well there is no end to knowledge sharing and what I like best about it is the more you share your knowledge with others, more you learn from them. So happy learning, happy reading!!

See you soon :):)