Regulatory Open Forum

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  • 1.  Are business skills important for RA professionals?

    Posted 26-Apr-2017 12:08

    I have been in regulatory for 14 years and have had a variety of focus areas as well as a number of leadership positions. Now that I am starting to focus on a particular company and career area, I want to make sure I support and lead in the best possible way. With companies focusing on revenue and growth, I believe that RA professionals need to understand all areas of a business to be able to make risk-based strategies and to make sure management understands the business risks associated. I think it's important to understand them from a business standpoint and not just a scientific standpoint. I recently registered for the RAPS Executive Development program to expand my knowledge in management, business and leadership skills. My goal is at the end of the program to take the knowledge I have learned back to the projects and programs I lead and push teams at a higher level. 

    My question for you all: what else have you done to develop your business skills to help you in the RA field, and do you think these or any other skills have made you a more successful RA professional?



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    Elizabeth McMeniman
    Senior Manager, Regulatory Affairs
    Sekisui Diagnostics
    Lexington MA
    United States
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  • 2.  RE: Are business skills important for RA professionals?

    Posted 27-Apr-2017 10:48
    Elizabeth,

    I applaud you for realizing that Regulatory Leaders need to be able to be "business leaders" as well as "regulatory experts." Too many people  mistake the fact that their companies are first and foremost, business enterprises - not charitable organizations, not professional development schools etc.

    The Kellogg course is very good (or was when I took it many moons ago). There are many, many other things you can do as well. Many are "experiential" though "class" based help as well - it is all in taking the learning and integrating into "doing. Some I have done over the years include the following:

     - take a finance class - you need to be able to understand a balance sheet, good will and other basic accounting/finance rules. If you work a t a start up, try and learn something about venture financing as well. A great source of this these days is online learning courses - there are tons of them

    - engage a leadership coach - having an independent person "on your side" can help you learn many, many skills as you evolve as a leader. Sometimes your company will pay for these, but if not it is worth it to finance yourself. Over the years I have learned many different things from different coaches, so interview a few to determine the fit

     - trade learning with professionals at your level in other organizations. Most people in pharm/med device want to know more about how regulatory works and very often they are willing to share more about how their areas work. For instance, I once scheduled recurring lunches for a year to learn about how supply chain and patient law basically work. My peers were happy to help

    - take on leadership of projects (or even departments) outside your skill area - it doesn't matter if this is coordinating a United Way campaign, running and R&D project, helping with a product launch etc. You truly learn to lead when you are NOT the technical expert and you have to get the best out of the people who ARE - all the while creating a vision that will motivate them. Over the years I did quite a bit of project management, as well as jumping into running Clinical, Quality and now Engineering.

    - if possible, get out and see cases using your products. Talk to customers. You will always provide a valuable voice in business discussions if you can add customer insight

    - take the opportunity to attend cross-functional meetings and go to the areas beyond regulatory. For instance, AdvaMed and Pharma have big conferences with tracks on reimbursement, compliance, funding, digital etc etc. Familiarity with all of these will help you better understand the broad business.

    Finally, one I did not do, but many people find helpful, is pursuing some type of MBA or executive MBA program. These obviously provide a broad business understanding, but do often require significant time and dollar committments.

    g-

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    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States
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    Original Message


  • 3.  RE: Are business skills important for RA professionals?

    Posted 28-Apr-2017 09:37

    Ginger,

    Those are all great suggestions - thank you for sharing!

    One of the advantages of working at a smaller company is that I've had to opportunity to get involved in our cross-functional voice of the customer teams, and have spoken to several users of our products, which has provided some valuable insights. I will definitely consider some of the other options, such as learning finance basics and getting involved in project management.

    Is there any additional advice you (or anyone else) have for someone earlier in their career to get on the management/business leader track?

    Thanks,

    Hiral



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    Hiral Dutia
    Advanced Instruments, LLC
    Norwood MA
    United States
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    Original Message


  • 4.  RE: Are business skills important for RA professionals?

    Posted 28-Apr-2017 17:54
    HIral, yes, at a small company, especially a very young start-up, you don't really have to work to get to know all areas of the company.  They tend to be right on top of you, to the point that, some days, you may wonder if you have come to know them all too well. :)

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
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    Original Message


  • 5.  RE: Are business skills important for RA professionals?

    Posted 27-Apr-2017 12:10
    I totally agree with your thoughts. Both scientific and business skills are important for a modern RA professional, also does the psychology.
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    Roy Feng, PhD, RAC



    Original Message


  • 6.  RE: Are business skills important for RA professionals?

    Posted 27-Apr-2017 15:13

    As always, "it depends." In this case, it depends on what you consider to be success as an RA professional.

    What you are describing---getting to know all areas of the company and attending leadership training, is the time-honored advice for anyone seeking to ascend into management, especially within their current company. The same advice is given to anyone who wants to ascend into management, regardless of where in the company they might be, not just to RA professionals.

    I would see this as success at ascending into management as an RA professional, rather than succeeding at RA as an RA professional.

    I actually chose to pursue an MBA because I thought it would better help me succeed at RA, and I have not been disappointed. However, what you need to succeed at RA depends on what kind of RA you want to succeed at.  In addition, as has already been noted, multidisciplinary is often helpful, so it also depends on what you already bring to the table.



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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 7.  RE: Are business skills important for RA professionals?

    Posted 02-May-2017 09:24
    Liz,

    Please consider the following:

    You should establish your own principles/philosophy in business career and life.  

    As for knowledge, it is important to be able to grasp many areas, to some extent (RA, QA, CA, business management, finance, etc.).

    RA exists only after business operation. Thus, RA should support sustainable business decision. 

    As for exercising judgment, please do what is best for the business in a legitimate and reasonable manner. 

    As for leadership, in view of firms' mission and purpose, what is best and how to pull the team to meet goals and objectives in a timely manner?  

    In many times, you would need to have your own answers for the following:

    When management expects you to do something that you believe it is neither legitimate nor reasonable - do you exit or go with the management?

    When you are asked to file regulatory submissions for the sake of jacking up stock price, knowing FDA will refuse to accept or reject applications after all.

    When you are motivated to take retaliatory actions against any former or current employees. etc. 

    You need to be ready, wiling, able to deal with any kinds of issues under all circumstances.  To do so, you would need to have power skills, knowledge, experience, education and/or training.  

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    REGULATORY DOCTOR
    Phone (Toll-Free): 1-(800) 321-8567

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





    Original Message


  • 8.  RE: Are business skills important for RA professionals?

    Posted 04-May-2017 09:49
    I agree with the most of the responses sent thus far.  In my specific case, after being with FDA and in the pharma industry for about 10 years, I felt that having more expertise in business was key to my personal career growth and the ability to be a successful leader.  I enrolled into an accredited graduated school and obtained an MBA degree while working.  The curriculum focused on general  business processes rather than solely on the pharma and biologics industries. Combining scientific knowledge with a good understanding of business enabled me to make greater contributions related to product development and in developing regulatory strategies for gaining FDA approval of our products.

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    Michael Trapani
    Senior Consultant
    Biologics Consulting Group, Inc.
    Monroe Township NJ
    United States
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    Original Message


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