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      Pfizer

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      Regulatory Affairs Manager Interview

      8 Jul 2023
      Anonymous interview candidate
      Chennai
      No offer
      Negative experience
      Difficult interview

      Application

      I applied through an employee referral. The process took 4 weeks. I interviewed at Pfizer (Chennai) in Jul 2023

      Interview

      Got the initial call from Pfizer's Talent Acquisition recruiter to discuss background and salary expectations, following which a virtual panel interview was scheduled. Since I had applied to multiple openings, I asked the recruiter to clarify which position I was being interviewed for. Recruiter responded that all the interviewers in the panel have openings in their teams and they will make a decision after the interview. I joined the panel interview meeting invite (MS Teams) 5 minutes before the scheduled start time. None of the panelists showed up for nearly 25 minutes. I had to call the recruiter and let her know that I had been waiting for almost half an hour for the interview to start. After which the panelists joined one by one and apologized for being late and explained that they had meetings that ran over. Then started the interview. I was asked to briefly introduce myself and then walk them through my CV, starting from my academic qualifications and work experience. I found it a little odd that they made me verbally state each one of my prior roles and the amount of time that I served in those roles despite having my CV in front of them. Then began the intense grilling with a flurry of questions based on definitions from ICH guidance documents. It felt like I was in a college Viva-voce. Based on my experience working in the US, no one is expected to know the information contained in the guidance documents by-heart. As long as you are able to know where to find the relevant guidance, you should be fine as you can build expertise over time. But here the expectations were different in that you are supposed to have all the regulatory guidance, strategy, filing mechanisms at your finger-tips. Only one question was based on my prior experience. None of the questions were behavioral based.

      Interview questions [1]

      Question 1

      1) Difference between reprocessing and reworking 2) Filing mechanism for manufacturing scale change 3) Heat Penetration Study for validation of depyrogenation tunnel 4) Define starting material 5) Do you know the ICH quality guidance documents? 6) Name the guidance documents that govern cGMP 7) Examples of process and product related impurities 8) Specific in vitro tests to determine the toxicological effects of product related impurities 9) Are you familiar with FDA's guidance on bispecific antibody development? 10) Hypothetical case - Assume that we have a product on the market with an established 24 month expiry period. During one of the ongoing stability studies, product degradation is observed at a 12 month time. What will be your approach to address this issue from a regulatory standpoint?
      Answer question

      Other Regulatory Affairs Manager interview reviews for Pfizer

      Regulatory Affairs Manager Interview

      5 Oct 2023
      Anonymous interview candidate
      Zürich
      No offer
      Positive experience
      Average interview

      Application

      I applied online. The process took 4 weeks. I interviewed at Pfizer (Zürich) in Mar 2023

      Interview

      First interview with HR over the phone (had to go over achievements, alignment with cultural fit/values), second (=last) interview with hiring manager on site. In the first interview they also checked knowledge of languages. Second interview very focused on the role and skills.

      Interview questions [1]

      Question 1

      Describe a challenge and how you overcame it; how do you handle priorities/deadlines and manage your time?
      Answer question