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  • 1.  Experience transitioning between Reg Ops and Affairs?

    This message was posted by a user wishing to remain anonymous
    Posted 02-Feb-2018 15:18
    This message was posted by a user wishing to remain anonymous

    Hi everyone,

    I wanted to see if anyone here has transitioned from a role in regulatory affairs to regulatory operations or from regulatory operations to regulatory affairs that would like to share their experience. If so please let me know what challenges, surprises and opportunities you found through out the process.  

    Thanks!



  • 2.  RE: Experience transitioning between Reg Ops and Affairs?

    Posted 08-Feb-2018 20:20
    If you can send me a private message, I can put you in contact with someone that I think could give you great perspective and has worked on both sides of the divide (and ultimately chose Operations).

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    Michael Petrini RAC
    Manager, Regulatory Affairs
    Lakewood CO
    United States
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    Original Message


  • 3.  RE: Experience transitioning between Reg Ops and Affairs?

    Posted 14-Feb-2018 01:27
    Transitioning between regulatory ops and affairs requires a different expertise.

    With respect to Regulatory operations, your expectations would be deliver dossiers by consolidating the scientific database and delivering it within stipulated timelines which your organisation would have targeted.

    Whereas, regulatory affairs is more dynamic as your predominant role is to understand the status of your filed applications at the respective regulator's, follow ups with regulators. You will have to have more understanding regarding the administrative procedures to understand and converse information to appropriate stakeholders (internal and external) at an appropriate stage. More often you would require sound soft skills to navigate discussion with regulators and also managing your scientific skill base within your organisation. 

    I hope above information helps


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    Indraneel Dasari RAC
    Associate Director
    HYDERABAD
    India
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    Original Message


  • 4.  RE: Experience transitioning between Reg Ops and Affairs?

    Posted 15-Feb-2018 15:01
    I am going to approach this one a little differently (heck, devices don't even typically differentiated between Reg Affairs and Reg Ops) - probably more like an executive than an RA pro.

    I'd say if at all possible you should try both. Why? A number of reasons
    - you will learn different skills; it is well known that most career growth comes with trying new assignments
    - you may find one that is your passion and you really want to do forever
    - you better understand the broader business and how it comes together (I can say this having done, RA, QA, Clinical and R&D/Ops)
    - you set yourself up for more opportunities in the future - say in smaller companies or consulting groups where roles may run into each other

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


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