Regulatory Open Forum

Hi everybody,

I am a 15 years experience MS pharmacist (between Italy and Albania), with 6 years as RA in Pharma. I came from EU 8-9 months ago and relocated to Pennsylvania.
My RA experience consist in submitting eCTD for small molecules, supplements, imports for small EU companies, in a non EU (and difficult RA reality) such Albania.
I've been looking for an entry level RA position from a few months.....and nobody wants me as I don't have US experience. Ok, I get it; that's why I am preparing the 2019 US RAC exam....
Please, can anybody tell me : should I be optimist for a job opportunity  if I pass the RAC????

------------------------------
Ardiana Capi
Doctor in Pharmacy
Media PA
United States
------------------------------

​Hi, Ardiana -

It sounds like you are having the classic challenge in regulatory - how to get experience, when all the posted jobs require experience.  But in your case, you have significant experience in EU and some challenging markets - would it be possible to leverage that experience to find a position in regulatory that covers those regions?  Then, once you have established a track record, take on additional responsibilities for US regulatory in the same company?  I would also recommend networking - it is likely that one of your contacts could recommend you to one of their contacts at a local company, which goes a long way in the hiring process.

Best of luck!

Cathy

------------------------------
Catherine Anderson PhD, RAC
Associate Director - Regulatory CMC
Hillsborough NC
United States
------------------------------

Original Message:
Sent: 15-Sep-2019 15:23
From: Ardiana Capi
Subject: Trying to be optimist.....

Hi everybody,

I am a 15 years experience MS pharmacist (between Italy and Albania), with 6 years as RA in Pharma. I came from EU 8-9 months ago and relocated to Pennsylvania.
My RA experience consist in submitting eCTD for small molecules, supplements, imports for small EU companies, in a non EU (and difficult RA reality) such Albania.
I've been looking for an entry level RA position from a few months.....and nobody wants me as I don't have US experience. Ok, I get it; that's why I am preparing the 2019 US RAC exam....
Please, can anybody tell me : should I be optimist for a job opportunity  if I pass the RAC????

------------------------------
Ardiana Capi
Doctor in Pharmacy
Media PA
United States
------------------------------

Original Message------

​Hi, Ardiana -

It sounds like you are having the classic challenge in regulatory - how to get experience, when all the posted jobs require experience.  But in your case, you have significant experience in EU and some challenging markets - would it be possible to leverage that experience to find a position in regulatory that covers those regions?  Then, once you have established a track record, take on additional responsibilities for US regulatory in the same company?  I would also recommend networking - it is likely that one of your contacts could recommend you to one of their contacts at a local company, which goes a long way in the hiring process.

Best of luck!

Cathy

------------------------------
Catherine Anderson PhD, RAC
Associate Director - Regulatory CMC
Hillsborough NC
United States
------------------------------

Good morning, Ardiana.​

Have you tried using recruiters? A lot of companies want EU regulatory experience, and it is possible a recruiter could find one willing to have you mentored in US RA. Have you considered consulting companies? In the right consultancy you may very well be exactly what they need - someone with EU experience. I see many RA positions on LinkedIn that very specifically want EU experience, and many of those are consultancies. The nice thing about working at consultancies is you typically have plenty of colleagues to ask advice or even mentor you.

I truly wish you the best of luck.

------------------------------
Arvilla Trag RAC
Director
BioProcess Technology Group
BDO
Boston MA
USA
------------------------------

Original Message:
Sent: 15-Sep-2019 15:23
From: Ardiana Capi
Subject: Trying to be optimist.....

Hi everybody,

I am a 15 years experience MS pharmacist (between Italy and Albania), with 6 years as RA in Pharma. I came from EU 8-9 months ago and relocated to Pennsylvania.
My RA experience consist in submitting eCTD for small molecules, supplements, imports for small EU companies, in a non EU (and difficult RA reality) such Albania.
I've been looking for an entry level RA position from a few months.....and nobody wants me as I don't have US experience. Ok, I get it; that's why I am preparing the 2019 US RAC exam....
Please, can anybody tell me : should I be optimist for a job opportunity  if I pass the RAC????

------------------------------
Ardiana Capi
Doctor in Pharmacy
Media PA
United States
------------------------------

Good morning Avilla and thank you for answering.
Yes, I have been considering consulting and I have written to some of them near me.
Now I have to write a CL and to check my Resume as suggested and ... hope! 
Meanwhile, I am really enjoying the US RAC! It's a nightmare doing the RA in EU with different agencies, different languages, national procedures, Mutual and so on....
I am really looking forward to do the RA in US!
Thank you and have a great day 
Ardiana

------------------------------
Ardiana Capi
Doctor in Pharmacy
Media PA
United States
------------------------------

Original Message:
Sent: 17-Sep-2019 06:50
From: Arvilla Trag
Subject: Trying to be optimist.....

Good morning, Ardiana.​

Have you tried using recruiters? A lot of companies want EU regulatory experience, and it is possible a recruiter could find one willing to have you mentored in US RA. Have you considered consulting companies? In the right consultancy you may very well be exactly what they need - someone with EU experience. I see many RA positions on LinkedIn that very specifically want EU experience, and many of those are consultancies. The nice thing about working at consultancies is you typically have plenty of colleagues to ask advice or even mentor you.

I truly wish you the best of luck.

------------------------------
Arvilla Trag RAC
Director
BioProcess Technology Group
BDO
Boston MA
USA

Original Message:
Sent: 15-Sep-2019 15:23
From: Ardiana Capi
Subject: Trying to be optimist.....

Hi everybody,

I am a 15 years experience MS pharmacist (between Italy and Albania), with 6 years as RA in Pharma. I came from EU 8-9 months ago and relocated to Pennsylvania.
My RA experience consist in submitting eCTD for small molecules, supplements, imports for small EU companies, in a non EU (and difficult RA reality) such Albania.
I've been looking for an entry level RA position from a few months.....and nobody wants me as I don't have US experience. Ok, I get it; that's why I am preparing the 2019 US RAC exam....
Please, can anybody tell me : should I be optimist for a job opportunity  if I pass the RAC????

------------------------------
Ardiana Capi
Doctor in Pharmacy
Media PA
United States
------------------------------

Hi Ardiana and other going through the entry into RA struggle,  
As a hiring manager who has looked at stacks of applications for entry level positions, I constantly give the advise of writing a cover letter that is specific to the job at hand.  When I am looking to bring someone in for an entry level position, I am looking for a few key attributes:
1) A general understanding of science (a degree typically checks this box)
2) Attention to details (a resume without typos)
3) The ability to express your ideas in a persuasive manner (a clearly organized resume) 
4) Evidence that they are willing to put in the work to learn (a cover letter showing that you looked into the company before you applied and said how you think your skills align)

The 4th bullet is really what lets applicants stand out.  When applying for an entry level position, you asking your employer to trust that you will be worth the training. Most entry level resumes look the same, so your cover letter is where you get freedom to explain why and how you believe that your skills will transfer.  If you can make this persuasive argument then you are well on your way to writing persuasive regulatory analyses.

------------------------------
Jayme Calhoun
VP of Regulatory Affairs
Saint Johns FL
United States
------------------------------

Original Message:
Sent: 15-Sep-2019 15:23
From: Ardiana Capi
Subject: Trying to be optimist.....

Hi everybody,

I am a 15 years experience MS pharmacist (between Italy and Albania), with 6 years as RA in Pharma. I came from EU 8-9 months ago and relocated to Pennsylvania.
My RA experience consist in submitting eCTD for small molecules, supplements, imports for small EU companies, in a non EU (and difficult RA reality) such Albania.
I've been looking for an entry level RA position from a few months.....and nobody wants me as I don't have US experience. Ok, I get it; that's why I am preparing the 2019 US RAC exam....
Please, can anybody tell me : should I be optimist for a job opportunity  if I pass the RAC????

------------------------------
Ardiana Capi
Doctor in Pharmacy
Media PA
United States
------------------------------

​Jayme - awesome advice! I really like the 4th bullet point.

------------------------------
Arvilla Trag RAC
Director
BioProcess Technology Group
BDO
Boston MA
USA
------------------------------

Original Message:
Sent: 17-Sep-2019 09:50
From: Jayme Calhoun
Subject: Trying to be optimist.....

Hi Ardiana and other going through the entry into RA struggle,
As a hiring manager who has looked at stacks of applications for entry level positions, I constantly give the advise of writing a cover letter that is specific to the job at hand.  When I am looking to bring someone in for an entry level position, I am looking for a few key attributes:
1) A general understanding of science (a degree typically checks this box)
2) Attention to details (a resume without typos)
3) The ability to express your ideas in a persuasive manner (a clearly organized resume)
4) Evidence that they are willing to put in the work to learn (a cover letter showing that you looked into the company before you applied and said how you think your skills align)

The 4th bullet is really what lets applicants stand out.  When applying for an entry level position, you asking your employer to trust that you will be worth the training. Most entry level resumes look the same, so your cover letter is where you get freedom to explain why and how you believe that your skills will transfer.  If you can make this persuasive argument then you are well on your way to writing persuasive regulatory analyses.

------------------------------
Jayme Calhoun
VP of Regulatory Affairs
Saint Johns FL
United States

Original Message:
Sent: 15-Sep-2019 15:23
From: Ardiana Capi
Subject: Trying to be optimist.....

Hi everybody,

I am a 15 years experience MS pharmacist (between Italy and Albania), with 6 years as RA in Pharma. I came from EU 8-9 months ago and relocated to Pennsylvania.
My RA experience consist in submitting eCTD for small molecules, supplements, imports for small EU companies, in a non EU (and difficult RA reality) such Albania.
I've been looking for an entry level RA position from a few months.....and nobody wants me as I don't have US experience. Ok, I get it; that's why I am preparing the 2019 US RAC exam....
Please, can anybody tell me : should I be optimist for a job opportunity  if I pass the RAC????

------------------------------
Ardiana Capi
Doctor in Pharmacy
Media PA
United States
------------------------------

Hi Jayme and thank you very much!
i really appreciate your advices. You know smth? Most of them are what my husband suggested me but as he is a sales guy and I am a RA, I didn't follow them.
 I will prepare a CL as you suggested me, thank you again.
Have a great day 
Ardiana

------------------------------
Ardiana Capi
Doctor in Pharmacy
Media PA
United States
------------------------------

Original Message:
Sent: 17-Sep-2019 09:50
From: Jayme Calhoun
Subject: Trying to be optimist.....

Hi Ardiana and other going through the entry into RA struggle,
As a hiring manager who has looked at stacks of applications for entry level positions, I constantly give the advise of writing a cover letter that is specific to the job at hand.  When I am looking to bring someone in for an entry level position, I am looking for a few key attributes:
1) A general understanding of science (a degree typically checks this box)
2) Attention to details (a resume without typos)
3) The ability to express your ideas in a persuasive manner (a clearly organized resume)
4) Evidence that they are willing to put in the work to learn (a cover letter showing that you looked into the company before you applied and said how you think your skills align)

The 4th bullet is really what lets applicants stand out.  When applying for an entry level position, you asking your employer to trust that you will be worth the training. Most entry level resumes look the same, so your cover letter is where you get freedom to explain why and how you believe that your skills will transfer.  If you can make this persuasive argument then you are well on your way to writing persuasive regulatory analyses.

------------------------------
Jayme Calhoun
VP of Regulatory Affairs
Saint Johns FL
United States

Original Message:
Sent: 15-Sep-2019 15:23
From: Ardiana Capi
Subject: Trying to be optimist.....

Hi everybody,

I am a 15 years experience MS pharmacist (between Italy and Albania), with 6 years as RA in Pharma. I came from EU 8-9 months ago and relocated to Pennsylvania.
My RA experience consist in submitting eCTD for small molecules, supplements, imports for small EU companies, in a non EU (and difficult RA reality) such Albania.
I've been looking for an entry level RA position from a few months.....and nobody wants me as I don't have US experience. Ok, I get it; that's why I am preparing the 2019 US RAC exam....
Please, can anybody tell me : should I be optimist for a job opportunity  if I pass the RAC????

------------------------------
Ardiana Capi
Doctor in Pharmacy
Media PA
United States
------------------------------

Ardiana:

There is a job post for a Global RA position on this news feed. Posted yesterday. Company is AstraZeneca. Look for it in the thread. It was posted by Arvind Mathur. There may be something you can apply to and connect with the gentleman who posted the job. Hope this helps! 

Monika

------------------------------
Monika House
MSHS, Regulatory Affairs Student
The George Washington University
Charlotte, NC
------------------------------

Original Message:
Sent: 15-Sep-2019 15:23
From: Ardiana Capi
Subject: Trying to be optimist.....

Hi everybody,

I am a 15 years experience MS pharmacist (between Italy and Albania), with 6 years as RA in Pharma. I came from EU 8-9 months ago and relocated to Pennsylvania.
My RA experience consist in submitting eCTD for small molecules, supplements, imports for small EU companies, in a non EU (and difficult RA reality) such Albania.
I've been looking for an entry level RA position from a few months.....and nobody wants me as I don't have US experience. Ok, I get it; that's why I am preparing the 2019 US RAC exam....
Please, can anybody tell me : should I be optimist for a job opportunity  if I pass the RAC????

------------------------------
Ardiana Capi
Doctor in Pharmacy
Media PA
United States
------------------------------

Hi Monika and thank you so much!
I am checking it right now. If it's gone be my job, I owe you a good italian wine!
 Thank you 
Ardiana

------------------------------
Ardiana Capi
Doctor in Pharmacy
Media PA
United States
------------------------------

Original Message:
Sent: 18-Sep-2019 09:44
From: Monika House
Subject: Trying to be optimist.....

Ardiana:

There is a job post for a Global RA position on this news feed. Posted yesterday. Company is AstraZeneca. Look for it in the thread. It was posted by Arvind Mathur. There may be something you can apply to and connect with the gentleman who posted the job. Hope this helps!

Monika

------------------------------
Monika House
MSHS, Regulatory Affairs Student
The George Washington University
Charlotte, NC

Original Message:
Sent: 15-Sep-2019 15:23
From: Ardiana Capi
Subject: Trying to be optimist.....

Hi everybody,

I am a 15 years experience MS pharmacist (between Italy and Albania), with 6 years as RA in Pharma. I came from EU 8-9 months ago and relocated to Pennsylvania.
My RA experience consist in submitting eCTD for small molecules, supplements, imports for small EU companies, in a non EU (and difficult RA reality) such Albania.
I've been looking for an entry level RA position from a few months.....and nobody wants me as I don't have US experience. Ok, I get it; that's why I am preparing the 2019 US RAC exam....
Please, can anybody tell me : should I be optimist for a job opportunity  if I pass the RAC????

------------------------------
Ardiana Capi
Doctor in Pharmacy
Media PA
United States
------------------------------

Hi everybody and thank you for your advices: they really helped me.
 I just want to apologize if my language has been more informal that the one used in this group, it's not me as usually. 
Thank you again 
Ardiana

------------------------------
Ardiana Capi
Doctor in Pharmacy
Media PA
United States
------------------------------

Original Message:
Sent: 15-Sep-2019 15:23
From: Ardiana Capi
Subject: Trying to be optimist.....

Hi everybody,

I am a 15 years experience MS pharmacist (between Italy and Albania), with 6 years as RA in Pharma. I came from EU 8-9 months ago and relocated to Pennsylvania.
My RA experience consist in submitting eCTD for small molecules, supplements, imports for small EU companies, in a non EU (and difficult RA reality) such Albania.
I've been looking for an entry level RA position from a few months.....and nobody wants me as I don't have US experience. Ok, I get it; that's why I am preparing the 2019 US RAC exam....
Please, can anybody tell me : should I be optimist for a job opportunity  if I pass the RAC????

------------------------------
Ardiana Capi
Doctor in Pharmacy
Media PA
United States
------------------------------