The top 10 mantras for being successful in Regulatory Affairs (RA) profession

Hey friends, 

In today’s blog I want to share my thoughts on what skill sets are required to excel in this profession. I call it as - THE REGULATORY MANTRA. Well basically these are few good practises which you should adopt, throughout your life, as RA professionals. These skill sets are good differentiators and the one who excels in these get recognized as a good RA professional. It will make you much more effective in delivering RA roles and responsibilities. 

Mantra 1: Your aim is to ensure the safety, efficacy and quality of the drug for which you are seeking an approval or a marketing license. 

Now if this is your mantra, obviously you must understand what safety, efficacy and quality of drug means. Thankfully, there is an ICH (International Council for Harmonisation of Technical Requirements. Follow link : https://www.ich.org/home.html

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and the pharmaceutical industry to discuss the scientific and technical aspects of drug registration. 

They have issued guidelines which is accepted worldwide and can be accessed on https://www.ich.org/products/guidelines.html 

The ICH topics are divided into four categories: Quality, Safety, Efficacy and Multidisciplinary and it serves as a good starting point to understand all critical technical aspects about drug. 

Now let me add a word of caution -   trying to understand so many guidelines in first go would be very intimidating. If you are accessing this site for the first time, the big question would be - where do I begin? According to me, it will depend on what you want to pursue. Are you going to be majorly involved in clinical trial submissions, then safety and efficacy guidelines are good to begin with. If you are intending to become a CMC (chemistry, manufacturing, control) specialist then quality guidelines is a right start for you to understand the requirements in greater depth and detail.  

Apart from ICH, there are WHO (World Health Organization) guidelines which can be also be referred to. It is important to note that apart for these guidelines, every country issues their own technical guidelines that are adopted from ICH/WHO.  

Mantra 2: Respect the law of the land and comply to it. 

What does this mean? It simply means that whenever your firm decides on a target market for selling a pharmaceutical product, you have to ensure that you have read the rules, regulation and guidelines of that specific country, understand it thoroughly and interpret it in the right manner. The next step would be to share with your firms’ internal key stakeholders, an exact list of requirements. As already specified, every country has their own set of specific requirements even if they are adopting ICH or WHO guidelines. So, it is prudent for the RA person to understand these differences and highlight the needs upfront so that the development, manufacturing, and marketing strategy is designed appropriately and data generated is accepted in these markets without many queries leading to faster approvals and faster entry to market.

Mantra 3: Maintain your knowledge base by upgrading it from time to time.

Keep abreast with all latest news on technology and keep track of changing laws, rules and regulations worldwide. This can be done easily by just signing up for email updates. As an example I have shared a link of CDER, FDA guidance documents.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents

If you click on this link and go down the page there is a provision given for signing up for guidance email updates. Similarly, you can sign up for updates from EU or any other health authorities.

Mantra 4: Network, Network and Network.

Networking is extremely essential for the flow of information and sharing of experience. So associating with regulatory groups on LinkedIn or attending seminars and conferences is a good way to connect with industry colleagues. Creating or joining Regulatory professionals’ group on WhatsApp is another good platform to share knowledge and experience.

Mantra 5: Work on principle of providing just enough information or data – not less and not more. 

I have realized through my years of experience that in this function ‘more is not merrier’. We are dealing with health regulators who receive applications from all over the world and they work on deadlines just like us. Completing the review and granting us approval on time is their mission. If our content is not well researched, well written, crisp and clear it will take them longer to understand and they may have to come back to us with lot of queries for additional clarifications. That’s precisely the reason why they have provided so many guidelines upfront. Through these guidelines the regulators are sharing their expectations upfront. Please learn the art of providing crisp information and provide only that specific information without beating around the bush. It is highly encouraged and appreciated by health authorities.

Mantra 6: Work on principle of RFT (right first time). 

This can be achieved only if you are able to apply scientific & regulatory principles from the stage when a drug is being shortlisted for development and by proactive planning and execution. Preparing a detailed checklist and sharing with each function is a good way of ensuring that the requirements have been communicated right at the outset without missing any critical elements. Conducting training sessions regularly also ensures that your knowledge about any guidelines is transferred across the firm.

While evaluating any data received with respect to a product from any function like R&D, Manufacturing, Clinical, etc the top three questions that should come into your mind are :

1. Whether all the data generated has been on the basis of scientific principles(wherever applicable), 

2. Have all the requirements mentioned in the guidelines been met and 

3. Are all final data authentic and well supported by raw data. If not, is there a sound scientific justification to it which can be explained to the regulators.

Anticipating the questions from regulators and providing data upfront to avoid queries while review of any application is something a RA personnel develops over the years based on the experience gained during interactions with health authorities.

According to me, this can also be acquired by going through case studies or queries received on other products that have been evaluated by these authorities. Authorities like FDA and EMEA post the summary of drug approval on their websites. Going through these data packages helps to understand the review process and queries raised on earlier submissions. Many health authorities, if not all, often conduct seminars, conferences and training sessions primarily to share the updates, concerns and expectations from the industry. Attend these or look for the presentations and recorded sessions which are posted on their websites within few days of these conferences being held. It’s the best learning platform for all RA professionals. As an example, I am sharing the link from FDA site which provides information on training sessions conducted by FDA from time to time. Its called CDER SBIA Learn : Webinars, Conferences, Trainings & Upcoming Events. Follow link : https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/cder-sbia-learn-webinars-conferences-trainings-upcoming-events

Mantra 7: Always keep a tab of regulatory commitments and post approval changes.

Most dossiers would provide commitments to submit data during the lifecycle management of the product post approval. In this era of continuous improvement there will be changes affected due to adopting better and newer technology. There is also a continuous need to keep costs under control, which will involve changes such as shifting to an alternate source of material used in the product. All these changes will lead to changes in the registered information/data set. RA professional should be at the centre of managing all post approval changes and updating health authorities by choosing the correct regulatory pathway, as and when the changes need to be implemented. So it is prudent to keep track, as missing to inform can have consequences. One of the ways this can be effectively managed is by maintaining a product history file which is a live document and captures the critical information, commitments and changes with respect to a product. 

Mantra 8: Always be audit ready. 

Pharmaceutical firms regularly come under the scrutiny and are audited by health authorities. Regulatory professional participate in such quality audits of the manufacturing facility and hence should securely maintain archives and repository of all data provided to health authorities. A good document management system can be used to track, manage and store documents. 

Mantra 9: Possess good IT skills.

In today’s digital era, good IT skills are must for almost all functions in any industry and more so in regulatory affairs as many health authorities around the globe have adopted paperless submission strategy and have their own set of requirements for providing e-submissions (electronic submissions) through their secured gateway or portal. Expertise in doing e-submissions can be achieved by way of on job training. But basic knowledge about word, excel and powerpoint is a must for entry into this function. 

Mantra 10: Develop good stakeholder management and negotiation skills. 

RA professional compiles data coming from R&D, Manufacturing, Packaging, Supply chain, Quality Assurance, Quality Control, Validation, Project management, Business Development, Labelling, Clinical/Bioequivalence teams. A good RA person needs to balance the objective of regulatory as well as of different functions and still manage to get data on time and in compliance.  Good RA professionals understands the position of stakeholders while sharing their priorities and ensures a win-win situation for both. That’s perfect negotiation skill!!

In my future blog I will share, through a case study, how systematic planning and proactive approach will help us in achieving timely submissions. See you soon!!

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)

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 :):)