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  • 1.  Hello RAPS Colorado!

    Posted 18-Jun-2018 12:27

    Hello RAPS Colorado!

    It looks like it has been awhile since there was a lot of activity in this group. I'd love to help organize some informal meet-ups of Regulatory professionals here in the local area. I am sending out notes to Regulatory folks on LinkedIn with an invitation to join and participate.

    I spoke with RAPS' Senior Program Manager, Chapter and Volunteer Relations recently and the goal is the professional networking and communication within the local Colorado community to eventually be able to develop a formal RAPS chapter. We can informally meet to shake hands and say hello anywhere in the area over coffee, lunch, dinner ect.

    I'll also start an introduction thread.

    Looking forward to networking!

    Lindsey



    ------------------------------
    Lindsey Summers, MBA
    Director, Pharmaceutical Consulting Division Green Key Resources, LLC
    Denver, CO
    Direct: 720.543.8692
    Mobile: 303.437.0391
    lsummers@greenkeyllc.com
    www.linkedin.com/in/lindseysummers

    http://www.greenkeyllc.com/ph/

    Regulatory Affairs / Medical Writing & Publications / Medical Communications & Information / Clinical Operations / Clinical Quality / Drug Safety / Data Management / SAS Programming / Biostatistics / Drug Development Project Management / Medical Affairs & Monitoring / Epidemiology / Health Outcomes

    *Receive up to $1500 for referring a colleague*

    Please note that in the state of California, Green Key conducts business under the name GK Pacific, LLC.
    ------------------------------


  • 2.  RE: Hello RAPS Colorado!

    Posted 19-Jun-2018 10:32
    Hello, Lindsey--

    I'm in Denver and pretty new to the regulatory field. I've worked in R&D at a medical device company for a number of years, and am currently in a graduate program in Regulatory Affairs.
    I would LOVE to network, as I'm changing careers when I graduate and am just learning the field.
    Thanks for reaching out!



    ------------------------------
    Kimberly Parker Howard
    Denver, CO
    www.linkedin.com/in/kparkerhoward
    ------------------------------

    Original Message


  • 3.  RE: Hello RAPS Colorado!

    Posted 19-Jun-2018 21:11
    Welcome Rick and Kimberly!

    Kimberly,

    Nice to so many Regulatory Master's, PhD and Certificate programs these days. I'm dating myself, but there really weren't too many when I started in this space. Northeastern, Rutgers, John's Hopkins, Temple, USC, Berkeley, Keck  and others are all producing good industry folks, but of course as always, experience is always key.

    ------------------------------
    Lindsey Summers, MBA
    Director, Pharmaceutical Consulting Division Green Key Resources, LLC
    Denver, CO
    Direct: 720.543.8692
    Mobile: 303.437.0391
    lsummers@greenkeyllc.com
    www.linkedin.com/in/lindseysummers

    http://www.greenkeyllc.com/ph/

    Regulatory Affairs / Medical Writing & Publications / Medical Communications & Information / Clinical Operations / Clinical Quality / Drug Safety / Data Management / SAS Programming / Biostatistics / Drug Development Project Management / Medical Affairs & Monitoring / Epidemiology / Health Outcomes

    *Receive up to1500 for referring a colleague*

    Please note that in the state of California, Green Key conducts business under the name GK Pacific, LLC.
    ------------------------------

    Original Message


  • 4.  RE: Hello RAPS Colorado!

    Posted 19-Jun-2018 12:02
    Hello all,

    I have been in the Colorado Area for 20 years and received my RAC cert in 2006.  I work for Celestica, a $6B contract manufacturer with sites across the globe.  We focus on manufacturing of non-medical electronics and medical devices.  Some of the finished medical devices we produce are not electronic, but are either implants or disposable tools used in the minimally invasive endoscopic surgical area.  We also manufacture electronic products as well.  Looking forward to communication with those in the Colorado area.

    ------------------------------
    Rick Muller RAC
    Technical Director
    Aurora CO
    United States
    ------------------------------

    Original Message


  • 5.  RE: Hello RAPS Colorado!

    Posted 26-Jun-2018 14:07
    Hello Lindsay and RAPS Colorado! 

    Thank you, Lindsay for re-energizing this group.  Our local talent pool in Colorado is very strong and very deep.  I hope this will be a great mechanism to connect Regulatory Affairs professionals in the local area to help promote the talent and opportunity that Colorado has to offer the life sciences industry. 

    Sincerely,
    Shawn

    ------------------------------
    J. Shawn Roach PhD, RAC
    Consultant II, Regulatory CMC
    Halloran Consulting Group
    Longmont CO
    United States
    ------------------------------

    Original Message


  • 6.  RE: Hello RAPS Colorado!

    Posted 26-Jun-2018 19:05
    Welcome Shawn,

    I truly can't wait to see what the future holds for everyone here in Colorado!

    ------------------------------
    Lindsey Summers, MBA
    Director, Pharmaceutical Consulting Division Green Key Resources, LLC
    Denver, CO
    Direct: 720.543.8692
    Mobile: 303.437.0391
    lsummers@greenkeyllc.com
    www.linkedin.com/in/lindseysummers

    http://www.greenkeyllc.com/ph/

    Regulatory Affairs / Medical Writing & Publications / Medical Communications & Information / Clinical Operations / Clinical Quality / Drug Safety / Data Management / SAS Programming / Biostatistics / Drug Development Project Management / Medical Affairs & Monitoring / Epidemiology / Health Outcomes

    *Receive up to1500 for referring a colleague*

    Please note that in the state of California, Green Key conducts business under the name GK Pacific, LLC.
    ------------------------------

    Original Message


  • 7.  RE: Hello RAPS Colorado!

    Posted 05-Jul-2018 13:55
    My name is Judy Therond, and I'm a Regulatory Consultant for biotech/pharma.  My education was B.S. in Biochemistry/Molecular Biology and prior to entering Regulatory I worked in a Clinical Lab at Mayo Clinic (Rochester, MN), then at a small biotech company in the Bay Area where I wore many (MANY) hats including QA/QC, Manufacturing Supervisor, and R & D.  The lab hours were quite drastic, so I started taking UC-Extension classes in a Certificate Program called "Clinical Trials Design and Management" which is where I learned about Regulatory Affairs.

    Long story short, I took a pretty big pay cut to start off in Regulatory Affairs at CV Therapeutics and haven't looked back.  I switched from employee to consultant back in 2006 and moved to Colorado in 2013.  I've kept several of my California clients for small projects, but my main client now is Array BioPharma in Boulder...who just received approval for BRAFTOVI and MEKTOVI last week!  

    I aid clients in the coordination, preparation, review and filing of U.S. and international regulatory submissions, and have worked on 3 NDAs, 2 SPAs, and many INDs/CTAs.

    Look forward to meeting in person in the near-future!

    Cheers,
    Judy Thérond
    JT Regulatory, LLC

    ------------------------------
    Judy Therond
    Regulatory Consultant
    Superior CO
    United States
    ------------------------------

    Original Message


  • 8.  RE: Hello RAPS Colorado!

    Posted 05-Jul-2018 18:57
    Hi Judy,

    Thanks for your introduction here and congratulations on the approval at Array! I just talked to a long time contact of mine moved out to Colorado to head up their Regulatory Ad/Promo function. Exciting stuff for the local market here!

    Very neat about the UC Santa Cruz Extension, a lot of my recruiting is in the SF Bay Area and it seems like a lot of successful Regulatory folks with Bay Area ties come out of the UC Santa Cruz and UC Berkeley industry programs in Clinical Trials and Regulatory. I've helped a number of people transition with contract opportunities during the programs or shortly after completing them.

    Welcome to the group!

    Lindsey




    ------------------------------
    Lindsey Summers, MBA
    Director, Pharmaceutical Consulting Division Green Key Resources, LLC
    Denver, CO
    Direct: 720.543.8692
    Mobile: 303.437.0391
    lsummers@greenkeyllc.com
    www.linkedin.com/in/lindseysummers

    http://www.greenkeyllc.com/ph/

    Regulatory Affairs / Medical Writing & Publications / Medical Communications & Information / Clinical Operations / Clinical Quality / Drug Safety / Data Management / SAS Programming / Biostatistics / Drug Development Project Management / Medical Affairs & Monitoring / Epidemiology / Health Outcomes

    *Receive up to1500 for referring a colleague*

    Please note that in the state of California, Green Key conducts business under the name GK Pacific, LLC.
    ------------------------------

    Original Message