Regulatory affairs phone interview

Interview Preparation

Interviews can go either way — successful, or not so much. It all depends on how you led the few days before an interview date. If you were busy preparing for the interview by looking up company information, and researching its standing in the market, the chances of your interview being successful increase manifold. If you were in a state of complacency, we are not sure how well you will fare! Firstly, it is imperative that you know exactly how the company stands. And then, it is imperative to go through at least some of the questions that may be asked during the interview process. Here is a set of interview questions and answers for a regulatory affairs associate position that you can go through for reference:. What industry have you predominantly worked for in the role of a regulatory affairs associate? Most of the 4 years that I have spent working as a regulatory affairs associate have been in the pharmaceutical industry. Was the work that you performed in a different capacity any similar to what you have done in the pharmaceutical industry? There was a little bit of difference in the sense that the type and nature of compliance was not similar to that prevalent in the pharmaceutical industry. Otherwise, the basic metrics were more or less the same. While working in pharmaceuticals, what were your prime duties in the role of a regulatory affairs associate? Evaluating the regulatory risks of corporate policies, developing new regulatory policies, determining if present and future products are in compliance with regulatory procedures and protocols, and writing reports and appeals have all been part of my work as a regulatory affairs associate in the past. What is the one skill that you believe one cannot work without, when working in this role? I believe that with technological advancements, so many things change on an almost daily basis. The one skill that you cannot work without is the ability to keep up with updates and information regarding regulatory compliance. On a scale of one to ten 1 being the lowestwhere do you rate the importance of regulatory compliance? I would give it a That is because companies that manufacture lifesaving drugs and equipment need to make sure that all the work that they do does not affect anyone adversely. Compliance to regulations is an absolute must. Where is your career journey taking you? Contrary to what many people believe, this work is highly fascinating. Owing to my intense interest in this regulatory compliance work, I am working hard to ensure that I reach the level of a specialist soon. Your email address will not be published. Leave a Reply Cancel reply Your email address will not be published.

Legal counsel interview questions

Finding another job can be so cumbersome that it can turn into a job itself. Prepare well for the job interviews to get your dream job. Here's our recommendation on the important things to You need to prepare for the job interview to achieve your career goals in an easy way. Regulatory Affairs is a government job handling the central affairs in fields such as industries, pharma, banking, energy, telecom etc. Their responsibilities are - working with federal, state, and local regulatory agencies, ensuring that their companies comply with all of the regulations and many more. Strong determination is required to crack the job. Follow our Wisdomjobs page for Regulatory Affairs job interview questions and answers page to get through your job interview successfully in first attempt. Question 1. What Is Regulatory Affairs? Answer : Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products in respective countries prior to their marketing. Question 2. Answer : Protection of human health Ensuring safety, efficacy and quality of drugs Ensuring appropriateness and accuracy of product information. Question 3. Answer : Act as a liaison with regulatory agencies. Providing expertise and regulatory intelligence in translating regulatory requirements into practical workable plans. Advising the companies on regulatory aspects and climate that would affect their proposed activities. Apart from the above main roles, there are various other roles which Regulatory Affairs professionals play. Question 4. Answer : It is an application which is filed with FDA to get approval for legally testing an experimental drug on human subjects in the USA. Question 5. Answer : The NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U. The data gathered during the animal studies and human clinical trials of an Investigational new drug become part of the NDA. Question 6. Question 7. Answer : A generic drug product is the one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. Answer : A Drug Master File DMF is a submission to the Food and Drug Administration FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Question 9. Question What Is A b 2 Application? Answer : Change in dosage form. Change in strength. Change in route of administration. Substitution of an active ingredient in a formulation product. Change in formulation. Change in dosing regimen. Change in active ingredient. New combination Product. New indication.

10 Tips For Your Next Regulatory Affairs Interview

But as the first point of direct human contact with a prospective employer, phone interviews can also be a source of anxiety. That's unfortunate—and the good news is, it's unnecessary, too. Ready to ace your phone interview? With a little planning and preparation, plus the following eight steps, you can conduct your phone interview with confidence and bring yourself that much closer to your dream job. Not knowing what to expect always adds anxiety. Your recruiter will probably tell you how long the interview is going to take ahead of time, but if not, be sure to ask. Thirty minutes to one hour is typical for a phone interview. It's best to take the call from a place that's quiet and where you're comfortable. How are you and the recruiter planning to connect? If it's just a simple phone call, wearing headphones equipped with a microphone can help cut out distracting ambient noise. If you're going to have a video call—for instance, using Skype or Google Hangouts—log into your account well in advance and do a trial run with a friend. You may need to adjust the microphone-input levels on your computer. And here's a professional tip: Don't just place your laptop flat on the kitchen table. Elevate it by putting it on a stack of books so you're looking directly into the camera. It's a much more flattering angle for everyone. Always keep in mind the four Cs of voice: You want to sound calm, comfortable, confident not cocky and conversational. If nervousness is an issue, plan to stage a quick phone call with a friend or family member immediately before the interview. That can help you settle into a more comfortable, conversational flow. If you're connecting over the phone without video, the absence of visual cues can be confusing. It may not always be clear if someone has actually finished speaking or is merely pausing mid-thought. That's why it's important to "telegraph" some structural aspects of language using the pitch of your voice. While researchers may disagree on the broader cultural meaning of "upspeak" —that is, when you raise your pitch as you approach the end of a phrase—in a phone interview you should use it to signify that you are asking a question. For declarative statements, do the opposite, starting in a higher register and ending on a lower one. Even if you know what you're going to say next, pause briefly before each answer. Doing so makes you say seem thoughtful, which can add weight and authority to your answer. It also gives you a chance to breathe. And remember: There's no need to fill in the silence with nervous-sounding filler words like "um" and "ah. You're probably going to encounter some variant of "Tell me a little bit about yourself," which is why it's a good idea to have something like your professional purpose or a brief summary of your experience and goals memorized and ready to dispense when needed. Here are two succinct yet effective examples of professional purposes:. Notice that, as both of these examples indicate, your professional purpose needs to blend your specific skills, training and interests as a candidate with the company's specific focus areas.

Regulatory Affairs Associate Interview Questions and Answers

If they haven't done so already, the recruitment company should have provided you with the following:. If this information hasn't already been provided, ask for it! It is in the recruitment company's interest for you to succeed just as much as yours. Despite our advice about utilising the services of the recruitment company, it is still your responsibility to research your potential new employer. As the old adage goes, 'failure to plan, is planning to fail'. Do not underestimate the power of your network when it comes to preparing for an interview. Nowadays, LinkedIn is the main source for most people when it comes to professional networking. It should be utilised as much as possible, to better understand the company you plan to work for, and the type of people working there. If you deem it appropriate, you may consider reaching out to people within your network that work, or have worked at your potential employer, for advice or information on what it is like to work there. It is important to do this in a respectful and professional manner; do not chase responses to your request as over-persistence can annoy some people. If approached courteously they may be willing to give you some valuable information. Most people are genuinely happy to help, if approached in the right way. The job description is very useful as it provides a clue about the type of interview questions you may receive. Put yourself in the shoes of the interviewer and develop a list of potential interview questions based on the list of required and preferred skills in the job description. If the job description for the role is limited and leaves you uncertain about what to expect at the interview, work with the recruitment company to identify the required and preferred skills. If you find yourself in this situation, draw up a separate list where you feel there are gaps in your skills or knowledge. Work through potential answers to questions regarding these gaps, drawing upon other work or life experiences and skills to show your potential employer your willingness to adapt and to learn. Rather than just considering a straight forward answer with figures, you should consider the benefit or value-added your experience in these areas could bring to your potential employer. This type of response will hopefully prompt further questions from the interviewer, and result in an engaging conversation during the interview. Focusing on how your experience can benefit your employer will help to differentiate you from the other candidates. Most job interviews now include behavioural questions, as it is believed that your past behaviour is a good indication of your future behaviour. Examples of such questions typically begin with "Tell me about a time when…?

Regulatory affairs Interview Questions & Answers

What is Regulatory Affairs? Ans- Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products in respective countries prior to their marketing. What are the goals of Regulatory Affairs Professionals? What are the Roles of Regulatory Affairs professionals? What is a Generic Drug Product? What is a DMF? What is a b 2 application? What kind of application can be submitted as a b 2 application? What are the examples of changes to approved drug products for which b 2 application should be submitted? What are the chemical classification codes for NDA? New ester, new salt, or other noncovalent derivative. Drug already marketed, but without an approved NDA. What are the differences between NDA and b 2 application? Generally, filed for newly invented pharmaceuticals. Generally, filed for new dosage form, new route of administration, new indication etc for all already approved pharmaceutical. Note: b 2 application is a type of NDA. What is a Marketing Authorization Application? Applications for new active substances are described as 'full applications'. What is an ASMF? Ans- Active substance master file is a submission which is made to EMA, MHRA or any other Drug Regulatory Authority in Europe to provide confidential intellectual property or 'know-how' of the manufacturer of the active substance. What are the types of active substances for which ASMFs are submitted? What is CTD? The Common Technical Document is divided into five modules:. Module 1. Administrative information and prescribing information. Module 2. Common Technical Document summaries Overview and summary of modules 3 to 5. Module 4. Nonclinical Study Reports toxicology studies. Module 5. What is Orange Book? What is Hatch-Waxman act? It is considered as the landmark legislation which established the modern system of generic drugs in USA.

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