Regulatory Open Forum

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  • 1.  Seeking volunteer opportunities to get regulatory experience

    Posted 16-Feb-2018 17:33
    Hi All,
    To begin with, I introduce myself with a quote "Learning is the only thing the mind never exhausts, never fears and never regrets"
    The key strengths that I possess to excel as regulatory professional include:
    • RAPS Certificate in Pharmaceuticals empowered to comprehend roles and responsibilities of regulatory professional, the lifecycle of drug product from discovery through post-market requirements, current reports on rapidly changing regulations, showcasing approval applications like IND NDA, ANDA, 510(K) and PMA
    • RAPS membership specially RegEx is facilitating me to understand the current trends and perceptions of the emerging pharmaceutical industry and connect with RA peers
    • Previous working experience qualify me to analyze the chemical information, assess quality control of the pharmaceutical product, communicate effectively with the process chemist & analyst to collect, analyze and interpret the data
    • Better understanding of the general properties, animal pharmacological and toxicological studies for product by applying knowledge of pharmacology, pharmaceutical chemistry & medical terminology obtained during academia
    My background
    I did Post Graduation in Pharmaceutical Chemistry from India and have 3 years of experience working in pharmaceutical companies including AstraZeneca as Research Associate in Synthetic and Quality Control department
    I moved to USA and was unable to work due to visa status and then I was on maternity break (2011-2017)
    With the intent of resuming my career and not wanting to do lab work, I did my research in various fields and decided to transition to regulatory affairs  as I can utilize my educational background and previous work experience in the best possible way and regulatory professional is multifaceted, who love details and passion to help others.
    I am RAPS member for a year now & got enrolled in a RAPS training program and completed with a certificate in 2017. Accomplishing comprehensive study, in particular, CDER and CDRH educational tool, Greenlight guru, attending the REdI 2017, and referring regulatory articles. 
    I have been actively seeking regulatory position from 3 months with no luck. I do get call from recruiter but they are looking for candidate with at least one year of  working experience.  I would really appreciate if anyone would be interested in providing the opportunity for volunteering.  I am open to take assignment to prove my ability for volunteer work and also, what are my chances of getting job if I go with 6 months to 1 year of volunteer work. . Can you please share your thoughts? Please feel free to reach out to me via VeenaR08@gmail.com.
    Thank you for your time and look forward to hearing from you all.


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    Veena Rao
    Mountain View, CA
    United States
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  • 2.  RE: Seeking volunteer opportunities to get regulatory experience

    Posted 17-Feb-2018 11:21
    Hi Veena,

    It was good to know about your career aspirations. It makes me understand how you would be feeling, as I also sharing the similar situation in life now, that I have moved to US after my marriage.

    Possessing a 25 years of experience in regulatory affairs and quality assurance in pharmaceuticals. I am also looking for volunteering opportunities in regulatory affairs and appearing for my RAC this year.

    Wish you All the Very Best !





  • 3.  RE: Seeking volunteer opportunities to get regulatory experience

    Posted 18-Feb-2018 02:23
    Thank you Shilpa.

    I wish you best of luck for your exam and success in your career..

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    Veena Rathnakar Rao
    Mountain View CA
    United States
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  • 4.  RE: Seeking volunteer opportunities to get regulatory experience

    Posted 18-Feb-2018 12:14
    No matter where you are, you can participate as a volunteer in a RAPS chapter near you. There's lots of manageable tasks you can take one, or chose one that requires more time if you have it.
    The quickest way to get a career boost may be to offer to plan an event for RAPS HQ or your chapter. You call a distinguished speaker (and make a business contact) to ask him/her to speak. You call a venue, usually one RAPS has worked with already so it's easy, and get a date. Then RAPS supports you by posting the notice, and, voila! you are a volunteer.
    You can ask colleagues what is the Next Big Issue for them and write an article for RAPS focus.
    You can also volunteer with PDA (which has chapters), DIA, FDLI, etc.
    I wouldn't volunteer for a regulated company.  Unless it's a formal intern/fellow program, you're unlikely to get exposure to the regulatory information you'd need to understand what's going on, and successful companies don't rely on informal programs of unpaid work.
    Good luck.

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    Andrea Chamblee Esq., RAC, FRAPS

    This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

    Silver Spring MD
    United States
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  • 5.  RE: Seeking volunteer opportunities to get regulatory experience

    Posted 18-Feb-2018 19:13
    Thank you Andrea for taking time and sharing your thoughts.

    I will consider writing an article for RAPS focus and look into other volunteer opportunities which you mentioned. Thanks again

    Happy weekend..

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    Veena Rathnakar Rao
    Mountain View CA
    United States
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