Regulatory Open Forum

Dear Members,

I am new to this community, trying to decide what i need to do next in my career after been a Cell biologist for last 16 years.

To get a clearer idea, i would like to get some information from other members who have been in wet lab environment and have transitioned out of it into Biomedical regulatory affairs.

I am planning to do the Dual certificate program course on RAPS. Is this certification enough for me to find an opportunity? Has anyone here been thru the something similar? If so how easy it was to find a job?

Any information would be very useful.

Thank you all in advance.

Anjali

Dear Members,

I am new to this community, trying to decide what i need to do next in my career after been a Cell biologist for last 16 years.

To get a clearer idea, i would like to get some information from other members who have been in wet lab environment and have transitioned out of it into Biomedical regulatory affairs.

I am planning to do the Dual certificate program course on RAPS. Is this certification enough for me to find an opportunity? Has anyone here been thru the something similar? If so how easy it was to find a job?

Any information would be very useful.

Thank you all in advance.

Anjali

Dear Members,

I am new to this community, trying to decide what i need to do next in my career after been a Cell biologist for last 16 years.

To get a clearer idea, i would like to get some information from other members who have been in wet lab environment and have transitioned out of it into Biomedical regulatory affairs.

I am planning to do the Dual certificate program course on RAPS. Is this certification enough for me to find an opportunity? Has anyone here been thru the something similar? If so how easy it was to find a job?

Any information would be very useful.

Thank you all in advance.

Anjali

Hi Anjali,

I did something similar to you where I transitioned out of an analytical chemistry environment in pharma as I didn't see many leadership opportunities for someone like myself. I had become more interested in medical devices and attempted to job search in the field. However, with only pharma experience no companies at the time were willing to hire me into a med device role. Thus, I pursued a full time MS in pharmaceutical/biomedical sciences. During this time, I was able to secure an international regulatory affairs co-op with a medical device company for my last year of MS. After this co-op and making sure to update my information on LinkedIn, Indeed, and Monster, I received several calls from recruiters for regulatory affairs roles in the med device field. The process still took about 3-4 months to find a role that I liked, but I am pleased with the result.

In your case, I would suggest seeking out companies that you think you may want to work for and conduct some informational interviews to find out where your interests lie and also make some connections within the field. If there is any opportunity - whether is it voluntary, part-time, etc - take it if you can and start building up some regulatory experience. If you have any opportunities to attend regulatory seminars, networking events, conferences, etc - take those too as you never know who you might meet. In addition, there are several free courses on FDA, EU regulations, and international regulations that you can start reading up on. This will give you an idea of which regulatory areas you may be interested in and give you more reg knowledge in general.

As for the RAPS certification, I think it is a good idea, but as I'm fairly new in my regulatory career and haven't received the certification yet, I don't think I'm qualified enough to comment on its merits. I'm sure there are plenty of people who can comment though!

Good luck,

Hiral

Dear Members,

I am new to this community, trying to decide what i need to do next in my career after been a Cell biologist for last 16 years.

To get a clearer idea, i would like to get some information from other members who have been in wet lab environment and have transitioned out of it into Biomedical regulatory affairs.

I am planning to do the Dual certificate program course on RAPS. Is this certification enough for me to find an opportunity? Has anyone here been thru the something similar? If so how easy it was to find a job?

Any information would be very useful.

Thank you all in advance.

Anjali

Hi,

I am also new to Regulatory Affairs, I am a pharmacologist with 16 years of industry experience. I am attending a RAC exam study group, and planning to start the RAPS certificate program soon as well.

I wanted to point out that there is the RAC certification, not to be confused with the RAC certificates (device, pharma, or dual).
As stated in one RAPS article:

"Candidates should be aware of the difference between certificates, including those offered by RAPS, and professional certifications, such as the  Regulatory Affairs Certification (RAC). The RAC is a professional credential earned by passing a rigorous exam, and must be maintained through continued professional development. It is not earned by completing specific coursework. 
RAPS’  Regulatory Affairs Certificate Program, which is sometimes confused with RAC, is very different from certification.
The certificate program is a series of online courses designed to give you knowledge in specific healthcare product areas—pharmaceuticals, medical devices or a combined certificate in both. Once earned, you receive a certificate that does not have ongoing maintenance or renewal requirements."

Is Regulatory Affairs Certification Right for You?

Alessandra

Hi Anjali,

I did something similar to you where I transitioned out of an analytical chemistry environment in pharma as I didn't see many leadership opportunities for someone like myself. I had become more interested in medical devices and attempted to job search in the field. However, with only pharma experience no companies at the time were willing to hire me into a med device role. Thus, I pursued a full time MS in pharmaceutical/biomedical sciences. During this time, I was able to secure an international regulatory affairs co-op with a medical device company for my last year of MS. After this co-op and making sure to update my information on LinkedIn, Indeed, and Monster, I received several calls from recruiters for regulatory affairs roles in the med device field. The process still took about 3-4 months to find a role that I liked, but I am pleased with the result.

In your case, I would suggest seeking out companies that you think you may want to work for and conduct some informational interviews to find out where your interests lie and also make some connections within the field. If there is any opportunity - whether is it voluntary, part-time, etc - take it if you can and start building up some regulatory experience. If you have any opportunities to attend regulatory seminars, networking events, conferences, etc - take those too as you never know who you might meet. In addition, there are several free courses on FDA, EU regulations, and international regulations that you can start reading up on. This will give you an idea of which regulatory areas you may be interested in and give you more reg knowledge in general.

As for the RAPS certification, I think it is a good idea, but as I'm fairly new in my regulatory career and haven't received the certification yet, I don't think I'm qualified enough to comment on its merits. I'm sure there are plenty of people who can comment though!

Good luck,

Hiral

Dear Members,

I am new to this community, trying to decide what i need to do next in my career after been a Cell biologist for last 16 years.

To get a clearer idea, i would like to get some information from other members who have been in wet lab environment and have transitioned out of it into Biomedical regulatory affairs.

I am planning to do the Dual certificate program course on RAPS. Is this certification enough for me to find an opportunity? Has anyone here been thru the something similar? If so how easy it was to find a job?

Any information would be very useful.

Thank you all in advance.

Anjali

Hi Alessandra,

I am planning to start with RAPS coursework because i do not have credentials to get RAC certification. I am working towards getting the credits for that.

Thanks

Anjali

Hi,

I am also new to Regulatory Affairs, I am a pharmacologist with 16 years of industry experience. I am attending a RAC exam study group, and planning to start the RAPS certificate program soon as well.

I wanted to point out that there is the RAC certification, not to be confused with the RAC certificates (device, pharma, or dual).
As stated in one RAPS article:

"Candidates should be aware of the difference between certificates, including those offered by RAPS, and professional certifications, such as the  Regulatory Affairs Certification (RAC). The RAC is a professional credential earned by passing a rigorous exam, and must be maintained through continued professional development. It is not earned by completing specific coursework. 
RAPS’  Regulatory Affairs Certificate Program, which is sometimes confused with RAC, is very different from certification.
The certificate program is a series of online courses designed to give you knowledge in specific healthcare product areas—pharmaceuticals, medical devices or a combined certificate in both. Once earned, you receive a certificate that does not have ongoing maintenance or renewal requirements."

Is Regulatory Affairs Certification Right for You?

Alessandra

Hi Anjali,

I did something similar to you where I transitioned out of an analytical chemistry environment in pharma as I didn't see many leadership opportunities for someone like myself. I had become more interested in medical devices and attempted to job search in the field. However, with only pharma experience no companies at the time were willing to hire me into a med device role. Thus, I pursued a full time MS in pharmaceutical/biomedical sciences. During this time, I was able to secure an international regulatory affairs co-op with a medical device company for my last year of MS. After this co-op and making sure to update my information on LinkedIn, Indeed, and Monster, I received several calls from recruiters for regulatory affairs roles in the med device field. The process still took about 3-4 months to find a role that I liked, but I am pleased with the result.

In your case, I would suggest seeking out companies that you think you may want to work for and conduct some informational interviews to find out where your interests lie and also make some connections within the field. If there is any opportunity - whether is it voluntary, part-time, etc - take it if you can and start building up some regulatory experience. If you have any opportunities to attend regulatory seminars, networking events, conferences, etc - take those too as you never know who you might meet. In addition, there are several free courses on FDA, EU regulations, and international regulations that you can start reading up on. This will give you an idea of which regulatory areas you may be interested in and give you more reg knowledge in general.

As for the RAPS certification, I think it is a good idea, but as I'm fairly new in my regulatory career and haven't received the certification yet, I don't think I'm qualified enough to comment on its merits. I'm sure there are plenty of people who can comment though!

Good luck,

Hiral

Dear Members,

I am new to this community, trying to decide what i need to do next in my career after been a Cell biologist for last 16 years.

To get a clearer idea, i would like to get some information from other members who have been in wet lab environment and have transitioned out of it into Biomedical regulatory affairs.

I am planning to do the Dual certificate program course on RAPS. Is this certification enough for me to find an opportunity? Has anyone here been thru the something similar? If so how easy it was to find a job?

Any information would be very useful.

Thank you all in advance.

Anjali

Hi Anjali,

I did something similar to you where I transitioned out of an analytical chemistry environment in pharma as I didn't see many leadership opportunities for someone like myself. I had become more interested in medical devices and attempted to job search in the field. However, with only pharma experience no companies at the time were willing to hire me into a med device role. Thus, I pursued a full time MS in pharmaceutical/biomedical sciences. During this time, I was able to secure an international regulatory affairs co-op with a medical device company for my last year of MS. After this co-op and making sure to update my information on LinkedIn, Indeed, and Monster, I received several calls from recruiters for regulatory affairs roles in the med device field. The process still took about 3-4 months to find a role that I liked, but I am pleased with the result.

In your case, I would suggest seeking out companies that you think you may want to work for and conduct some informational interviews to find out where your interests lie and also make some connections within the field. If there is any opportunity - whether is it voluntary, part-time, etc - take it if you can and start building up some regulatory experience. If you have any opportunities to attend regulatory seminars, networking events, conferences, etc - take those too as you never know who you might meet. In addition, there are several free courses on FDA, EU regulations, and international regulations that you can start reading up on. This will give you an idea of which regulatory areas you may be interested in and give you more reg knowledge in general.

As for the RAPS certification, I think it is a good idea, but as I'm fairly new in my regulatory career and haven't received the certification yet, I don't think I'm qualified enough to comment on its merits. I'm sure there are plenty of people who can comment though!

Good luck,

Hiral

Dear Members,

I am new to this community, trying to decide what i need to do next in my career after been a Cell biologist for last 16 years.

To get a clearer idea, i would like to get some information from other members who have been in wet lab environment and have transitioned out of it into Biomedical regulatory affairs.

I am planning to do the Dual certificate program course on RAPS. Is this certification enough for me to find an opportunity? Has anyone here been thru the something similar? If so how easy it was to find a job?

Any information would be very useful.

Thank you all in advance.

Anjali

Hiral's advice about finding a creative entry is very good. For instance, over the years I have developed at least 3 of my department's administrative assistants into Regulatory Professionals. These were very smart and educated people (one was a Rhodes Scholar) who took these roles as "first steps" out of college or while they were studying. Over time, we began giving them more and more true regulatory work (often in our international markets) rather than simply administrative work. As they gained skills, they took on more and more complex markets and all eventually moved up and on into full fledged, global, regulatory affairs roles. This may not work for folks further into their careers, but can be a good starting place.

If you really want to go into Regulatory Affairs, you need to be creative about pursuing and creating opportunities to get started. Typically, just a degree or certificate will not be enough in and of itself.

g-

Hi Anjali,

I did something similar to you where I transitioned out of an analytical chemistry environment in pharma as I didn't see many leadership opportunities for someone like myself. I had become more interested in medical devices and attempted to job search in the field. However, with only pharma experience no companies at the time were willing to hire me into a med device role. Thus, I pursued a full time MS in pharmaceutical/biomedical sciences. During this time, I was able to secure an international regulatory affairs co-op with a medical device company for my last year of MS. After this co-op and making sure to update my information on LinkedIn, Indeed, and Monster, I received several calls from recruiters for regulatory affairs roles in the med device field. The process still took about 3-4 months to find a role that I liked, but I am pleased with the result.

In your case, I would suggest seeking out companies that you think you may want to work for and conduct some informational interviews to find out where your interests lie and also make some connections within the field. If there is any opportunity - whether is it voluntary, part-time, etc - take it if you can and start building up some regulatory experience. If you have any opportunities to attend regulatory seminars, networking events, conferences, etc - take those too as you never know who you might meet. In addition, there are several free courses on FDA, EU regulations, and international regulations that you can start reading up on. This will give you an idea of which regulatory areas you may be interested in and give you more reg knowledge in general.

As for the RAPS certification, I think it is a good idea, but as I'm fairly new in my regulatory career and haven't received the certification yet, I don't think I'm qualified enough to comment on its merits. I'm sure there are plenty of people who can comment though!

Good luck,

Hiral

Dear Members,

I am new to this community, trying to decide what i need to do next in my career after been a Cell biologist for last 16 years.

To get a clearer idea, i would like to get some information from other members who have been in wet lab environment and have transitioned out of it into Biomedical regulatory affairs.

I am planning to do the Dual certificate program course on RAPS. Is this certification enough for me to find an opportunity? Has anyone here been thru the something similar? If so how easy it was to find a job?

Any information would be very useful.

Thank you all in advance.

Anjali

Hi Anjali,

I did something similar to you where I transitioned out of an analytical chemistry environment in pharma as I didn't see many leadership opportunities for someone like myself. I had become more interested in medical devices and attempted to job search in the field. However, with only pharma experience no companies at the time were willing to hire me into a med device role. Thus, I pursued a full time MS in pharmaceutical/biomedical sciences. During this time, I was able to secure an international regulatory affairs co-op with a medical device company for my last year of MS. After this co-op and making sure to update my information on LinkedIn, Indeed, and Monster, I received several calls from recruiters for regulatory affairs roles in the med device field. The process still took about 3-4 months to find a role that I liked, but I am pleased with the result.

In your case, I would suggest seeking out companies that you think you may want to work for and conduct some informational interviews to find out where your interests lie and also make some connections within the field. If there is any opportunity - whether is it voluntary, part-time, etc - take it if you can and start building up some regulatory experience. If you have any opportunities to attend regulatory seminars, networking events, conferences, etc - take those too as you never know who you might meet. In addition, there are several free courses on FDA, EU regulations, and international regulations that you can start reading up on. This will give you an idea of which regulatory areas you may be interested in and give you more reg knowledge in general.

As for the RAPS certification, I think it is a good idea, but as I'm fairly new in my regulatory career and haven't received the certification yet, I don't think I'm qualified enough to comment on its merits. I'm sure there are plenty of people who can comment though!

Good luck,

Hiral

Dear Members,

I am new to this community, trying to decide what i need to do next in my career after been a Cell biologist for last 16 years.

To get a clearer idea, i would like to get some information from other members who have been in wet lab environment and have transitioned out of it into Biomedical regulatory affairs.

I am planning to do the Dual certificate program course on RAPS. Is this certification enough for me to find an opportunity? Has anyone here been thru the something similar? If so how easy it was to find a job?

Any information would be very useful.

Thank you all in advance.

Anjali

Thanks for your advice Hiral, I am planning to join ORCA (which will give me access to seminars and RAC meet ups here in Seattle) I am hoping to make some connections via this and you suggested i will look into companies which can provide me an opportunity to do some volunteer work. I will try and see if I can get an internship so that it will break the door open for me.

Thanks

Anjali

Hi Anjali,

I did something similar to you where I transitioned out of an analytical chemistry environment in pharma as I didn't see many leadership opportunities for someone like myself. I had become more interested in medical devices and attempted to job search in the field. However, with only pharma experience no companies at the time were willing to hire me into a med device role. Thus, I pursued a full time MS in pharmaceutical/biomedical sciences. During this time, I was able to secure an international regulatory affairs co-op with a medical device company for my last year of MS. After this co-op and making sure to update my information on LinkedIn, Indeed, and Monster, I received several calls from recruiters for regulatory affairs roles in the med device field. The process still took about 3-4 months to find a role that I liked, but I am pleased with the result.

In your case, I would suggest seeking out companies that you think you may want to work for and conduct some informational interviews to find out where your interests lie and also make some connections within the field. If there is any opportunity - whether is it voluntary, part-time, etc - take it if you can and start building up some regulatory experience. If you have any opportunities to attend regulatory seminars, networking events, conferences, etc - take those too as you never know who you might meet. In addition, there are several free courses on FDA, EU regulations, and international regulations that you can start reading up on. This will give you an idea of which regulatory areas you may be interested in and give you more reg knowledge in general.

As for the RAPS certification, I think it is a good idea, but as I'm fairly new in my regulatory career and haven't received the certification yet, I don't think I'm qualified enough to comment on its merits. I'm sure there are plenty of people who can comment though!

Good luck,

Hiral

Dear Members,

I am new to this community, trying to decide what i need to do next in my career after been a Cell biologist for last 16 years.

To get a clearer idea, i would like to get some information from other members who have been in wet lab environment and have transitioned out of it into Biomedical regulatory affairs.

I am planning to do the Dual certificate program course on RAPS. Is this certification enough for me to find an opportunity? Has anyone here been thru the something similar? If so how easy it was to find a job?

Any information would be very useful.

Thank you all in advance.

Anjali