Regulatory Open Forum

 View Only

  • 1.  New to the Field

    Posted 19-Apr-2017 00:34

    Hello everyone,

    I am sure this question has surfaced more than once but my situation is a little different. I'd like to know my chances of breaking into a regulatory/clinical trial/drug development position paying well over 100K. I currently have a PhD in organizational behavior and I have been working with the US federal government (defense sector) for over 6 years. I do not have any experience in regulatory affairs or drug development. I am an expert in statistical analysis, research design, and organizational behavior practices. I plan to begin using RAPS online training to become versed with regulations and policies. Also, I have begun reading regulation books on drug development project management and drug development regulations. All in all, I have developed a passion for drug development regulations but I cannot afford a drastic pay cut as a result of a career change. Any advice would be appreciated. Thanks for reading.

     



  • 2.  RE: New to the Field

    Posted 19-Apr-2017 17:59
    As per the pharma companies who makes drugs have typical pay scale range as below:

    RA Manager: 110-125k
    RA Specialist: 80-90k
    RA Senior Associate: 65-70k
    RA Associate: 45-50k

    Associate level starts with 0 experience and eventually add 3 years for each tier. So you can imagine how much hands on experience is required to get more than 110k in RA field in pharma companies. If you are lucky enough and get a good start from big pharma company than that will be outstanding.

    This applies everywhere and every field. Hands on experience is a must key and if you have background of RA will be great help.

    ------------------------------
    Gaurang Bhavsar
    Edison NJ
    United States
    ------------------------------

    Original Message


  • 3.  RE: New to the Field

    Posted 20-Apr-2017 02:34
    That's kind of what imagined. Thanks so very much for your input. 

    Original Message


  • 4.  RE: New to the Field

    Posted 21-Apr-2017 12:18
    Jordan,
    I would suggest taking the RAC and then looking at positions at the FDA. With a PhD and 6 years in the gov't you'll likely start as a GS-13-1 (95k) at minimum. A GS-14-1 is 112k in the DC area.


    ------------------------------
    Michael Nilo
    Network Regulatory Partners
    Nilo Medical Consulting Group
    Portland OR
    United States
    ------------------------------

    Original Message


  • 5.  RE: New to the Field

    Posted 21-Apr-2017 12:42
    Jordan,

    Michael's suggestion is a great one.

    I can see you offer an outstanding value based on your expertise to drug development, review and/or approval team.

    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


  • 6.  RE: New to the Field

    Posted 22-Apr-2017 09:23
    Thanks Michael; however, the RAC certification requires at least one year of experience in the field with a PhD. That's the one thing that I do not have.
    Original Message


  • 7.  RE: New to the Field

    Posted 20-Apr-2017 08:33

    Since you are already in a government position, have you looked at positions at NIH or FDA? It may be easier to repurpose your skills and to get hands on training in drug development within the government sector.

     

    Linda Bowen

    RAPS NJ NY Chapter Chair




    Original Message


  • 8.  RE: New to the Field

    Posted 22-Apr-2017 09:29
    Hi Linda,

    I thought about this as well but not having experience in the field would prohibit me from applying for positions. I guess I could get a certificate(s) and use this as training experience . I'll pretty much do whatever is necessary to break into the industry.
    Original Message


  • 9.  RE: New to the Field

    Posted 27-Apr-2017 10:54
    I would push on this if you can. Once you get several years of FDA experience, you can pretty much negotiate your price in private industry, or do decently as a consultant. Given you already have jumped through a lot of the government hurdles, this would be an ideal step - see if you can get someone to tell you the minimum you would need to get in the door at FDA - maybe even with a temporary assignment.

    g-

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

    Original Message


Related Content