Regulatory Affairs, widely referred to as RA, is one department that is not familiar to many as compared to other departments like Manufacturing, Research & Development, and Quality. These three departments along with Regulatory Affairs are the four pillars which are crucial for the success of a pharmaceutical company. With the onset of the pandemic and the subsequent COVID19 vaccines, students interested in this stream and public in general have gained some insights on the fact that any drug, be it prophylactic, therapeutic, or health supportive, should receive a nod from the regulatory authority before it hits the market for procurement and consumption.

Knowledge Required by RA Personnel

Companies undergo a very complex process of submitting the details about their products, processes, facility and personnel to get the required approval from the concerned authority to produce and market the product in indigenous or export markets. Unlike the professionals who work in other departments where they are required to have a deep knowledge of their domain, the personnel who work in RA need to have a deep understating about the regulatory framework, processes, and pathways.

Additionally, the RA personnel are also required to have a broad knowledge on research, manufacturing, and quality of the product in question. This is one of the reasons why RA department usually attracts people with some experience in varied departments cited above when they join RA department. Thus, it becomes a limiting factor for a fresh pass out from college to join this department directly. However, there are instances where freshers join the department as interns and gain experience before they start their professional journey.

Skills & Career Prospects

More than technical skills, professional skills including and not limited to good written and oral communication skills, organizing skills, conflict management, stakeholder management and working in teams become very important in building a strong career in this department and grow further.

As good as other departments, RA department offers a potential career prospects to stay in the domain and grow. Though the teams which work are divided based on the region for which they work like the highly regulated markets including the USA, Europe, Japan etc., and emerging markets like ASPAC, Latin America, South Africa, and so on, the skills required to work in such teams remains common.

In general, the professionals who join the pharma and biotech companies gain experience in different departments and visibility to RA department. They realize the significant work the Regulatory Affairs team does by being a bridge between the global regulatory agencies and the company, and then they tend to join the RA department.

The Biocon Academy Advantage

Biocon Academy has recently announced Biocon JSS AHER Certificate Program in Global Regulatory Affairs which is one-of-its-kind course to facilitate the participants in gaining visibility on the Global Regulatory Affairs in terms of the framework, processes and pathways thereby paving way to join this most exciting RA department.

With this certificate program, students get the opportunity to learn from experienced faculty of Biocon and JSS Academy of Higher Education and Research and gather experience and practical knowledge before they are even hired by a pharma/biopharma company.

Click here to know more about Biocon JSS AHER Certificate Program in Global Regulatory Affairs

Watch this Instagram Live we recently hosted featuring Anil Sachdeva, Vice President, Regulatory Science, Biocon, to know more Regulatory Affairs including career prospects and the required skills. During the LIVE, we even answered a lot of questions asked by our followers and RA aspirants.

Authored By

Salavadi Easwaran
Academic Dean
Biocon Academy


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