Regulatory Open Forum

 View Only

  • 1.  An advice to start a Regulatory Affairs Consultancy business in US

    Posted 06-Jan-2023 15:41
    Hi there, I would really appreciate your experience, tips, advice, etc. 
    This is the background,
    I own a very successful Regulatory Affairs Consultancy Company in Chile, and for the Chilean market only. I actually live in the US since 2011, I already took the MD RAC exam and just waiting for the results. I have been capable to make my Chilean company grow, and managing it from here. I´m including my website for an idea about the experience and services that we provide www.latitudconsultores.cl

    My goal now is to start providing services in the US, for the US and European markets, but I need to get some experience first. Because of that, I was looking for remote part-time jobs or even an Intern option. The problem that I see is that all the jobs require experience in submissions by FDA or Europe, which I don´t have yet. The intern option, they are more oriented to a college student, which I´m not either.

    According to my studies in Chile and the US transcript, I have here a bachelor's and Master's degree in Quemist and Pharmacist.

    My request to you is to give me some experiences that you have in a similar situation, or any useful ideas to build my business here in Oregon. 

    Thanks so much, and I can´t wait to read your responses!!!!
    Happy new year to everyone,
    Ale




    ------------------------------
    alejandra Quiros Sanchez
    Owner of Latitud US
    Lake Oswego OR
    United States
    ------------------------------


  • 2.  RE: An advice to start a Regulatory Affairs Consultancy business in US

    Posted 07-Jan-2023 10:32
    Hi Alejandra

    It's an interesting challenge. If you want to cover US and EU, for drugs, devices, disinfectants, foods, and animal products, there are a lot of relevant agencies to get a feel for, as well as huge numbers of laws, regulations, guidance documents, standards, etc.

    My first question would be if your strengths and interests are mostly on the side of running the business or doing the consulting. If the former, I might begin by developing relationships with people who already have marketable experience. If the latter, then yes, I expect you'll need to get some experience.

    There are usually more full-time than part-time job opportunities. Maybe you could take on some temporary full-time work.

    I don't know if you tend to be more of a generalist or a specialist. If the latter, you might study all the available information for one niche area, so you could market yourself as an expert in that area, perhaps equally or more valuable than candidates having generally related experience with less specialized expertise.

    In the regulatory world it is very common to have lots of education and lots of work experience and still be a beginner, which makes matching candidates to jobs a more complex calculation than in some other fields.


    ------------------------------
    Anne LeBlanc
    United States
    ------------------------------

    Original Message


  • 3.  RE: An advice to start a Regulatory Affairs Consultancy business in US

    Posted 09-Jan-2023 10:02
    Thank you Anna,
    you gave me a great perspective. I would love to do both, my goal is to build a team capable of covering different areas. But as a starting point, I would say specialist.

    I´ll keep working to reach my dreams ;)
    Ale

    ------------------------------
    Alejandra Quiros Sanchez
    Owner of Latitud US
    Lake Oswego OR
    United States
    ------------------------------

    Original Message


  • 4.  RE: An advice to start a Regulatory Affairs Consultancy business in US

    This message was posted by a user wishing to remain anonymous
    Posted 09-Jan-2023 08:27
    This message was posted by a user wishing to remain anonymous

    Hi Alejandra,

    There are several things you can do.
    1. Network. Discuss, ask questions. Make contacts you can call later if you have a question.
    2. Reread your RAC exam study guide frequently. It contains a lot of information.
    3. Attend as many educational webinars and focused conferences as possible. Take lots of notes, ask lots of questions and network. 
    4. Read every article you can on U.S. and EU regulatory topics, them make yourself a table comparing the Chilean requirements to the U.S. and EU requirements. Doing this will reinforce your recall and be an excellent tool for reference later. 
    5. Network. Having contacts you can call for input is the most valuable thing an independent consultant can have.

    I hope this helps, I wish you the best of luck.
    Original Message


  • 5.  RE: An advice to start a Regulatory Affairs Consultancy business in US

    Posted 09-Jan-2023 10:07

    Thank you so much for your response, I really appreciate it. 
    I´m currently doing N°3. I have been working on the networking in US and Europe, but still slow, I have a solid one in Chile.
    I loved your N°4.
    Thanks again,

    Ale​



    ------------------------------
    alejandra Quiros Sanchez
    Owner of Latitud US
    Lake Oswego OR
    United States
    ------------------------------

    Original Message


Related Content