Roles and Responsibilities - Regulatory Affairs (RA)

Hey friends,

In today’s blog I will share about roles and responsibilities of this function, but before that let me just briefly touch upon the educational aspects.

If you want to start your journey in pharmaceutical industry, specifically in this function, the first step is to choose the right educational background which is a Diploma in Pharmacy (D’Pharm), Bachelor of Pharmacy (B’Pharm) or Masters of Pharmacy (M’Pharm). There are various courses designed for specialisation in regulatory affairs after completing D’Pharm and/or B’Pharm. Globally, many reputed educational institutions and universities are offering M’Pharm in regulatory affairs. There are many certification courses as well. The distant learning courses offered by many institutions can be easily done online to gain knowledge.

Before making any decision, you need to have some basic idea about roles and responsibilities.

Pharmaceutical industry is highly regulated industry and every drug before it is approved for marketing goes through the scrutiny and clinical trials to ensure it safety, efficacy and quality.

To achieve this objective a regulatory person should be well versed with the laws, regulations & guidelines of the regulatory agencies such as USFDA (United States Food and Drug Administration), European Union of Drug Regulatory Affairs (EUDRA), or Drug controller General of India (DCGI), etc. In any pharmaceutical firm the RA function is typically the source of information on international regulatory issues, where RA professionals typically monitor and analyse regulatory issues for multiple nations and regions of the world.

During registration of products for granting product approval or license to sell the drug in any market, RA professional is involved in all aspects of the dossier preparation such as writing summaries, compiling, publishing, and submitting dossier to regulatory agencies followed by handling query and managing reports during review of dossier.

At later stages after product approvals, RA professionals are increasingly involved in tracking post-marketing activities and changes as part of life-cycle management of product. Products marketing, advertising, and communications are vetted by RA to ensure no such claims are made which is not aligned with commitments and information shared about the product during registration. They are also involved in aspects of commercial manufacturing, packaging and distribution, and business strategy, particularly as related to global submission strategies and policies. RA professional regularly participate in audits and inspections conducted by health authorities to check compliance of site.

However, please note that at an entry level you may not be involved in all the activities. A regulatory job during your initial days would be more of reading and understanding guidelines and interpreting it correctly so as to ensure compliance to market specific rules and regulations. Compilation and submission of product dossiers for registration purpose sometimes under the guidance of a manager who would be reviewing your dossiers before final submission, query responses on submitted dossiers, labelling and preparing content of package inserts, and maintenance of your dossiers by submitting change updates to health authorities.

As you gain more experience, skill sets and business sense, you will be moving towards more strategic roles, like getting involved in making regulatory policies and making global submission strategy for your firm, attending meetings with health authorities, due diligence, handling audits by FDA, EU and other global agencies, strategic evaluations of molecules during product selections, risk based analysis evaluating regulatory as well as business risk, representing your firm in regulatory forums etc

In my next blog I will share the top 10 mantras for becoming successful in this function. See you soon!!

Sharing a link about regulatory certification course
Regulatory Affairs Professionals Society (RAPS)