Regulatory Open Forum

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  • 1.  Question of the Week 9/1

    Posted 01-Sep-2021 08:30
    You have been asked to sit on a committee to help reorganize your company. What title would you recommend for the person in charge of the regulatory function?

    a. VP of Regulatory reporting to the President
    b. Director of Regulatory reporting to the Head or VP of R&D.
    c. VP Regulatory reporting to the head of operations.

    If you'd like to submit a question for Question of the Week, please email regex@raps.org.

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    Eileen Quinn
    Community Manager
    Regulatory Affairs Professional Society
    regex@raps.org
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  • 2.  RE: Question of the Week 9/1

    Posted 01-Sep-2021 08:41
    a. VP of Regulatory reporting to the President.

    It depends on the size of the company but all other things being equal, I personally prefer that the RA function report directly to the president/CEO. The RA risks are similar enough to QA to warrant this reporting structure.  It bypasses any risk of conflict of interest with other reporting structures that can influence regulatory decisions. Ultimately, the buck stops at the President/CEO's desk.

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    [Carmen] [Betancourt-Riche]
    [Executive Vice President (ret)]
    [RA Ready, LLC]
    [Novato] [CA]
    [USA]
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    Original Message


  • 3.  RE: Question of the Week 9/1

    Posted 02-Sep-2021 09:29
    I would agree - VP or RA reporting to the president, for all the reasons already mentioned. I suppose a 4th related option would be VP or RA reporting to the VP or RA/QA, who in turn reports to the president.


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    Manan Hathi RAC
    Sr. Manager, Regulatory Affairs - Software
    Flower Mound TX
    United States
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    Original Message


  • 4.  RE: Question of the Week 9/1

    Posted 02-Sep-2021 08:31
    If this person is meant to be the head of the group, then in my opinion the proper title would have Vice President involved.  As for the reporting structure, to me, a VP reports to a President.  More importantly, as Carmen noted previously, a different reporting structure might be completely workable "in general" but almost always will risk the "appearance of conflict" which for me is a deal-breaker.  Even if the operations person is as straight-laced and buttoned up as anyone else in the organization, the fact that you are reporting to someone who typically as part of their objectives is about production, sales, profit margin, etc. could lead an outsider to "believe" there is a conflict even if that isn't the case.  It is reasonable to avoid these whenever possible because they bring up questions that are unnecessary and can cause many problems for the company depending on the way they are answered, any assumptions by the outsider, etc.

    If you were to have a regulatory function that only went to the level of Director, then I think (b) is also an option but as I noted earlier, a head of any department (meaning executive level responsibility) should be in my opinion at the VP level.

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    Victor Mencarelli
    Global Director Regulatory Affairs
    MelvilleNY
    United States
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    Original Message


  • 5.  RE: Question of the Week 9/1

    Posted 03-Sep-2021 08:34
    I think option A is generally the best. But in my last 3 roles, as VP of RA, I have reported to the Chief Medical Officer/SVP.  This has worked well. I have the access to the CEO as often as I need, but the CMO generally filters the information for the CEO.
    Anything less than a VP title gives the appearance that there is someone else in charge of Regulatory.

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    Beth Weinberg
    Regulatory Affairs Lead
    Carmel IN
    United States
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    Original Message


  • 6.  RE: Question of the Week 9/1

    Posted 04-Sep-2021 08:08
    A funny side note here. Small companies do not have VPs.
     

    Honestly, title inflation is rampant everywhere.  (In banking 20 years ago, kids just graduating from college were hired as "Assistant VPs" or "VPs" which was a crock).  No wonder Recruiters think RA Directors should be paid 50k, with 10 years global experience.

    The reporting relationship to CEO /Top Management who accepts the importance of RA/QA is the key.

    Wouldn't it be nice if there was standardization in titles.  Titles alwas make me laugh out loud these days, and anyone at the higher levels is quite often not handling submissions, mostly strategy,  Powerpoints, and crises.



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    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
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    Original Message


  • 7.  RE: Question of the Week 9/1

    This message was posted by a user wishing to remain anonymous
    Posted 03-Sep-2021 11:32
    This message was posted by a user wishing to remain anonymous

    Absolutely VP of Regulatory reporting directly to the President/CEO. 

    Head of Regulatory reporting into R&D or reporting into Operations are recipes for disaster.
    Original Message


  • 8.  RE: Question of the Week 9/1

    This message was posted by a user wishing to remain anonymous
    Posted 07-Sep-2021 11:49
    This message was posted by a user wishing to remain anonymous

    Completely agree, but in my experience Regulatory reporting into R&D or Operations is very common regardless of company size.  Moreover, in recent years Regulatory seems to be viewed as more operational than strategic in nature.
    Original Message


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