Disclaimer: This article is more helpful for anyone who is fresher, wishing to start career or having about 0 to 2 years of experience in drug regulatory affairs. For writing this article, it was important to talk to people who regularly conduct interviews and ask them what are their expectations and what are they looking in candidate while conducting interviews. I was fortunate enough to receive inputs from experienced professionals who have been regularly conducting technical DRA (Drug Regulatory Affairs) interviews from many years. Furthermore, this article is not about preparation on general questions like- “tell me about yourself, where do you see yourself in next five years or why do you want to join our company etc.” There are many sites with best answers for preparation on general interview questions. This article attempts to focus more on expectations of interviewers from candidates and technical preparation for drug regulatory affairs interview for 0-2 years of experienced aspirants. Also it is to be noted that every interviewer has his/her own way of judging and selecting candidates as per suitability of vacancy. Hence this article should be considered as only a guide or reference while preparing for drug regulatory affairs interview.
Drug regulatory
affairs interview questions may be grouped in following categories:
I)
CMC
(Chemistry, Manufacturing and Controls) based
II)
Life
cycle management based
III)
Labelling
IV)
Publishing
V) Miscellaneous
I) CMC (Chemistry, Manufacturing and controls) based
questions:
CMC is major and
important part of any dossier or drug master file. Below questions could be asked related to CMC part:
I.A) Filing process:
One of the very basic questions that may be asked by interviewer irrespective of market or the number of years of experience a candidate has, is filing process for the said market. For this it is expected to know complete process right from application of filing to final submission.
I.B) Administrative requirements:
Knowledge of administrative requirements are also one of the important parameters. Even this requirement varies from country to country. In many cases, administrative documents are screened before reviewing the dossier. If any of the documents are missing, then the agency may not start review until administrative requirements are fulfilled. Try to know how what all documents are required; how many copies are required in administrative section of dossier.
I.C) Differences in market:
All countries follow ICH guidelines, however, still there are differences in requirement of dossier for each country. Knowing these differences can be of good advantage while working in regulatory field. E.g. Differences in DMF requirements in US and EU market. Differences between South Africa and Brazil market. etc.
I.D) Variation guidelines:
Variation is also another name for the term “change”. So when any sort of changes occurs, it is expected to report the changes to respective regulatory authority of the country where the product is registered. There are guidelines mentioned by health agencies of respective countries on how to report changes. The changes may vary from minor to major. So even variation guidelines have been prepared accordingly. Hence if you are well versed with variation guidelines, you may save lot of time and even money of the organization by minimizing the changes and reporting accordingly.
II) Lifecycle management:
II.A) Knowledge about eCTD:
Major nations of the world are accepting electronic submissions through eCTD format. Other nations are in process of switching to eCTD. Soon we may see all regulatory submissions in eCTD format throughout the world. Hence if you are having knowledge about eCTD, then it will be an added advantage. Try searching websites to learn about various eCTD softwares available in market.
II.B) Timelines :
All countries have their own timelines for approvals, sending queries from date of submission, audits trigger points, etc. Try to know these timelines required for as many countries as possible. This will keep you well aware of status for ongoing project. Some countries require that changes in submitted drug master file should be submitted on annual basis.
III) Publishing:
Publishing is basically filing or submitting compiled dossier or drug master file through electronic submission gateway to intended country. This is done with the help of publishing softwares. Get to know various publishing softwares available in market. There is separate vacancy only for publishing in some organizations.
IV) Labelling:
Labelling is basically part of finished formulation. Commonly expected questions could be differences between SMPC (Summary of Product Characteristics) and PIL (Patient information leaflet) and pack insert, components or contents of labelling materials, minimum requirements that should be present on a label etc. Like publishing, even for labelling there are separate vacancies in some organizations.
V) Miscellaneous:
Below points,
though grouped as miscellaneous are very important for preparation of
interview.
V.A) Purpose:
If you are complete fresher in field of drug regulatory affairs, then you should always expect this question of “WHY?”. With so many options available in pharmaceutical sector, there is high chance of being asked as why did you choose this career in particular. This question should be answered with complete sincerity since your answer could decide type of questions that would be asked further.
V.B) ICH guidelines:
Knowledge of ICH guidelines is very necessary for every drug regulatory affairs aspirant. These are very basic requirements and it is expected to know ICH guidelines very well. Though not all guidelines may be asked in interview, but one should not miss out on important guidelines as well. Q1A, Q1B, Q2A, Q2B, Q3A, Q5C, Q6A, Q6B, M7 are one of the important guidelines. This in any way doesn’t mean to mug up the guidelines. The whole purpose of ICH guidelines knowledge will be lost if guidelines are mugged up. It is very important to co-relate the guidelines with dossier or drug master file sections.
V.C) Fees:
Knowledge about fees may probably be considered more important than technical knowledge itself. Almost all countries have their own DMF filing fees, dossier filing fees, facility fees, variation fees etc. This fee changes every year from country to country. Some regulatory agencies display fees on websites while some do not display fees. With knowledge of fees, if you are able to save the big amount by avoiding variations, timely filing etc. then you could be an important asset for hiring company.
V.D) Formulas:
ICH recommends various formulas for factors like having better control over impurities, calculation of daily dose requirement, calculating retest period, assigning expiry period, genotoxic impurities etc. As a regulatory professional it is expected to have knowledge about these formulas which can be very helpful while reviewing or preparation of specifications.
V.E) Current updates:
Being updated with most recent development or changes can be very advantageous not only for facing the interview but also in the long run of career. You may surprise the interviewers by showing level of curiosity in subject matter. Check all the recent developments even on the day of you interview, because changes happen on daily basis. This is not only applicable to DRA, but for all fields. Following is a real incident faced by an experienced RA professional few years ago in one of the drug regulatory affairs interview. After some technical questions, this person was asked about full form of ICH. As mentioned in first point, ICH is a very basic requirements and it is expected to know ICH guidelines very well. This person answered it correctly. But at the end of interview, he asked the interviewers as why such a basic question like full form of ICH was asked to him since he was not even a fresher. One of the interviewers replied that full from of ICH had been recently changed from International CONFERENCE of Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to International COUNCIL of Harmonisation of Technical Requirements for Pharmaceuticals for Human use. Most candidates still mentioned CONFERENCE instead of COUNCIL
V.F) Brief knowledge on Quality Assurance (i.e. QA):
A brief knowledge on quality assurance can be of great use while working in DRA. Complete information of QA is not expected but knowing basic terms like what is a change control, what is a CAPA, what is a change notification, what is an LIR etc. will help a lot. Knowing these terms will be beneficial in understanding the system of document flow.
V.G) Know what NOT to do:
This is a bit of tricky and difficult part especially for persons with no experience. Knowing what not to do comes from experience and learning from mistakes. All the guidelines, information on regulatory agency websites and other platforms will mostly display what is required and what needs to be done. Even in this article, above mentioned points are regarding what to do. But if you know about the things that should not be done, then there are great chances of avoiding major blunders. RTR guidelines (Refuse to Receive standards) mentioned in USFDA website is kind of guidelines that clearly mentions set of things that should not be done during submissions and if they are found during screening, then agency may refuse to receive the submission.
Above points mainly focused on technical requirements that are expected in drug regulatory affairs interview. However, there are few non-technical things may be considered more important than having technical knowledge. Below are some of non-technical things that some interviewers consider more to be important than having good technical knowledge. Some interviewers even claimed that if a candidate is very strong in technical knowledge but not at all good in a few non-technical things then that candidate does not qualify for the post in spite of being technically sound. Let’s explore some very important non-technical things which need some serious attention.
V.H) Communication skills:
Having good communication skills is one of the most important requirement in any career. Not only in career, but even in personal life communication skills matter a lot. In regulatory affairs field, one has to communicate daily with lots of people within the company, with stake holders, local and international customers, auditors, people in higher position in health agencies, owners and presidents of other companies etc. communication not only refers to verbal communication but also how you write emails. The words you use in your emails while communicating with different levels of persons speak a lot about the person you are. You need to have strong communication skills when it comes to dealing with such important persons of industry. One of the interviewer even said that if a person is having very good communication skills but technically, not up to expectations still that person qualifies for the job. Technical flaws could be overlooked as those things can be learnt in working environment but poor communication skills cannot be overlooked since a lot of work is mostly based on communication skills. Hence having good communication skills is very important while working in drug regulatory affairs.
V.I) Team player
Being a team player means how well you get along with the team and how your presence can benefit to the team. This is a type of quality that can be observed as the time passes by. Drug regulatory affairs is among those careers where you will realize that all days are not the same. Most of the days there are several new challenges. You might have to face a problem due to change in any guideline and you have to comply the requirements according to newly applicable guideline. it could also be request from regulatory agency which has to be sufficed within specified period of time etc. These are the kind of situations wherein quality of team player is developed in you. How well you support the team to get things done, how well you take a stand for your team during difficult situations are analyzed during such situations.
V.J) Sincerity:
A very basic but one of the very important quality that interviewers expect is sincerity. It is reflected not only in how you do your work but also how you present yourself and the way you have written your CV. One of the interviewers observed that just to make the CV look more attractive, some people even include about the things that they have only heard about, when asked in detail then there is no answer to what they have written. The interviewer further added that if you do not know the answer of any question that is being asked in interview, then accepting the fact that you don’t know its answer will be far more advantageous rather than giving any vague answers and trying to bluff. The interviewers are smarter than you and can spot in matter of seconds if you really know the answer or if you are trying to bluff it.
So to conclude this article, these were some of the important points one needs to take care of before attending drug regulatory affairs interview.
