What is the work of a Regulatory Affair Specialist?

Regulatory affairs specialists stay updated on regulations in different countries and help with negotiations to get advertising and marketing authorizations for the goods or devices to be marketed. Right from the manufacturing of goods to its marketing in a nation, the RA specialist serves as a channel between the companies and regulatory authorities. So this job requires good command on science, business, writing skills and languages belonging to that nation.

Regulatory affairs jobs are found in biotechnology as well as pharmaceutical organizations, medical device companies, diagnostic laboratories, cosmetics, and nutritional goods manufacturing companies.

 

What are the criteria to pursue a job in Regulatory Affairs?

Regulatory affairs specialists belong to numerous disciplines like science, law, industrial study, and academics. Jobs in regulatory affairs are readily available at different levels depending upon the qualifications of the prospective person. People with an undergraduate degree in the areas of life sciences, clinical sciences, engineering, business, public health or even other associated disciplines are suitable to become Regulatory Affairs Associates whose main responsibility involves administrative activities like data management, project tracking and general assistance to senior-level professionals. However, senior-level regulatory specialists tend to have an M.D., or a doctoral degree or both of these. They are the decision-makers on several strategic as well as technical aspects associated with drug manufacturing and also marketing. Nevertheless, all the professionals go through cross-functional training so as to acquaint them with all factors of regulatory affairs. Communication skills are a crucial requirement for this job. Actually it could be said that in no other area are communication skills more important than in regulatory affairs.

 

How to make your career in regulatory affairs?

Many institutes offer industry-specific training courses in the sector of regulatory affairs across the globe. Institute of Pharmaceutical Management(IPM) is a leader in clinical research training with students from multiple nations joined into various training courses. IPM provides numerous self-paced courses created by the industry experts in the sector of regulatory affairs to assist individuals to get entry into different positions like Regulatory affairs executive, Regulatory affairs manager, Regulatory affairs associate, senior-level regulatory professionals, etc.