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How to become a Regulatory Affairs Specialist?

Regulatory Affairs

How to become a Regulatory Affairs Specialist?

Anyone who has an interest in the regulatory field must have a very pronounced love of detail. … While the regulatory elements of a job like this can be learned, if you can’t manage tiny nuances of data in a multigigabyte document, you’re in trouble.

                                                                                                     –Shannon Strom

                                                                                                      A Senior Regulatory Scientist


What does a Regulatory Affair Specialist do?

Regulatory affairs specialists stay up-to-date on regulations in various countries and facilitate negotiations to gain marketing authorizations for the product or device to be marketed. Right from manufacturing of a product to its marketing in a country, the RA specialist acts as a channel between the companies and regulatory authorities. So this job demands a great command on science, business, writing skills and languages native to that country.  

Regulatory affairs jobs are found in biotechnology and pharmaceutical companies, medical device manufacturers, diagnostic labs, cosmetics and nutritional products manufacturing companies.

What are the requirements to pursue a career in Regulatory Affairs?

Regulatory affairs professionals belong to various disciplines such as science, law, industrial research and academic. Jobs in regulatory affairs are available at various levels depending on the qualifications of the prospective individual. Individuals with an undergraduate degree in the fields of life sciences, clinical sciences, engineering, business, public health or even other related disciplines are eligible to become Regulatory Affairs Associates whose primary responsibility includes administrative activities such as data management, project tracking and general assistance to senior level professionals. On the other hand, senior level regulatory professionals tend to have an M.D., or a doctoral degree or both. They are the decision makers on various strategic and technical aspects related to drug manufacturing and marketing. However, all the professionals are subjected to a cross-functional training in order to acquaint them with all aspects of regulatory affairs. Communication skills are key prerequisite for this job. In fact it could be stated that in no other field are communication skills more significant than in regulatory affairs.  

How to make a career in regulatory affairs?

Various institutes provide industry specific online training programs in the field of regulatory affairs across the world. James Lind Institute (JLI) is a pioneer in clinical research training with students from more than 40 countries enrolled into various online training programs. JLI offers various self-paced programs designed by the industry experts in the field of regulatory affairs to help individuals gain entry into various positions such as Regulatory affairs executive, Regulatory affairs associate, Regulatory affairs manager, senior-level regulatory professionals etc. The programs available in this category are:

1. Advanced PG Diploma in Regulatory affairs and Medical Writing

which helps the students understand regulations pertaining to clinical trials, regulatory documents to be created during the trials and how to write the documents along with various templates.

2. Professional Diploma in Pharmaceutical Regulatory Affairs

which provides a deep understanding of different regulatory agencies such as US FDA, EMA, CDSCO, their regulatory strategies, investigational and new drug applications and other related concepts.

3. Advanced Post Graduate Diploma in Regulatory Affairs and Quality Assurance

which exposes the students to two crucial aspects of drug development and clinical trials – Regulatory Affairs and Quality Assurance.

Technologically advanced e-campus at James Lind Institute acts as a contemporary substitute to standard classroom programs. In addition, JLI offer personalized classroom activities through an Online Campus Tutoring Centre, mock drills, tutoring and freelancing opportunities.

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