j******w
发帖数: 97 | 1 Lately, there seemed to be quite a few posts about regulatory affairs, in
which RA has favorably been depicted as a stepping-stone to leave the bench,
an area of better job security in light of the massive layoffs in the
Pharmaceutical industry and a path to a more rewarding career. I would like
to throw in a few lines and some random thoughts, based on my limited
understanding and light experience on RA, and hope to start a discussion
that may benefit those who are interested in venturing into |
j******w
发帖数: 97 | 2 1) What is regulatory affairs?
Regulatory is a vast field. Everyone probably has their own understanding
what regulatory affairs means, which functional divisions are included in it
and what responsibilities it assumes.
I personally think anything that operates under the mandates of a drug law
and regulation is regulatory affairs. I have also divided RA into several
sub-areas based on the specific functions, with the sole intention to
conveniently illustrate the complexity of RA. They are probab |
j******w
发帖数: 97 | 3 2) What background do I need in order to be successful in RA?
Per sub-areas identified in 1), it is readily to identify what SCIENTIFIC
background may be necessary to excel in that particular sub-area.
1) Clinical: medical/nursing/pharmacy/pharmacology/statistics
2) Regulatory strategy: none
3) Regulatory operations: none
4) CMC: chemistry and/or biology
5) QA/Compliance: chemistry/biology/process
6) PV: medical/nursing/pharmacy/pharmacology
7) Labeling/promotion/advertising: public relations, b |
i**f
发帖数: 1195 | 4 nice job done! thank you for sharing with us. |
ot
发帖数: 4549 | 5 Pharm里的RA specialist多少年薪？
【在 j******w 的大作中提到】
: Lately, there seemed to be quite a few posts about regulatory affairs, in
: which RA has favorably been depicted as a stepping-stone to leave the bench,
: an area of better job security in light of the massive layoffs in the
: Pharmaceutical industry and a path to a more rewarding career. I would like
: to throw in a few lines and some random thoughts, based on my limited
: understanding and light experience on RA, and hope to start a discussion
: that may benefit those who are interested in venturing into
|
j******w
发帖数: 97 | 6 3) What are the pros and cons of working in RA compared to working in a
scientific capacity?
Cons:
1) Heavy workload. Most of the RA people I worked with seemed to be
overloaded with work no matter what their levels are. Some of the
expressions I heard frequently were “I have been up to my eyeballs in work
”, “I am so behind my work that I need to start early tomorrow”. RA at
the manager and up levels always seem to have a full schedule of meetings
and they have to pick and choose the most impor |
z****t
发帖数: 75 | 7 赞！！！谢谢分享，期待着看续帖。
【在 j******w 的大作中提到】
: 3) What are the pros and cons of working in RA compared to working in a
: scientific capacity?
: Cons:
: 1) Heavy workload. Most of the RA people I worked with seemed to be
: overloaded with work no matter what their levels are. Some of the
: expressions I heard frequently were “I have been up to my eyeballs in work
: ”, “I am so behind my work that I need to start early tomorrow”. RA at
: the manager and up levels always seem to have a full schedule of meetings
: and they have to pick and choose the most impor
|
j******w
发帖数: 97 | 8 4) Should I move to RA?
When I was assessing if it was worthwhile to leave my own field and start
from zero in RA, I created a list to help myself make the decision.
1) How much harder do I have to work in order to secure a bright future, 10,
20 years down the road, if I stay in my field and what’s the chance of
being able to do so vs. how much work there is if I start from zero in RA.
2) Do I want to work in research all my life?
3) Can I deal with people?
4) Can I accept a few year’s setback i
【在 j******w 的大作中提到】
: 3) What are the pros and cons of working in RA compared to working in a
: scientific capacity?
: Cons:
: 1) Heavy workload. Most of the RA people I worked with seemed to be
: overloaded with work no matter what their levels are. Some of the
: expressions I heard frequently were “I have been up to my eyeballs in work
: ”, “I am so behind my work that I need to start early tomorrow”. RA at
: the manager and up levels always seem to have a full schedule of meetings
: and they have to pick and choose the most impor
|
j******w
发帖数: 97 | 9 5) How can I get in RA?
Frankly, I don’t know. I can only share what I heard from people about
their ways of entering/transitioning into RA.
1) Change within the same organization. This seems to be the most used path
by people who started their career in other functions like research. Some
switched by assignment, others for personal interests. I also think this is
probably the least risky way. If you are in a pharma/biotech company and
would like to work in RA, keep your eyes and ears open for a |
s******n
发帖数: 189 | 10 Nice comment!
Waiting for 6 |
|
|
j******w
发帖数: 97 | 11 6) Does an advanced degree benefit/hurt a career in RA?
There is a misconception that RA jobs are only for bachelors. That’s not
true. As I have said before, RA is heavily driven by technical principles,
chemistry/biology, toxicology, medical… The approval of a drug is mainly
determined by science, secondarily by negotiation, presentation and politics
. FDA has the responsibility to the public to ensure (at least to a
reasonable extend) the safety and effectiveness of a drug. “Convincing”
FDA th |
w****5
发帖数: 81 | 12 nice job! Thanks for sharing! |
j******w
发帖数: 97 | 13 Just saw the Sino-American Pharmaceutical Professionals Association (SAPA)
will be hosting a symposium on regulator affairs. Some of the sessions seem
to be quite useful for those who are interested in getting into RA.
You can go to their website for more details.
http://www.sapaweb.org/new/index.htm
3: 00 – 4:45 PM Session III
Bridging Careers from Research Labs to the Regulatory Field
Xin Du, Ph.D., Jerry Huang
3: 00 - 3:25 “Preparation before Applying for a Job in the RA Field”
Xin Du, Ph.D., |
W********t
发帖数: 8514 | 14 Ok, Ok, I have to say somethin on this topic here.
1st, let's use a simple way to picture RA and QA. QA, think about GMP, GLP,
GCP, GTP; RA, think about IND, ANDA, IDE, BLA, 510K
2nd, yes RA/QA get paid well, but this is a small field. |
p*****n
发帖数: 52 | 15 Great comments. If how to join into the RA field as chinese can be provided
is more useful.
bench,
like
work
【在 j******w 的大作中提到】
: Lately, there seemed to be quite a few posts about regulatory affairs, in
: which RA has favorably been depicted as a stepping-stone to leave the bench,
: an area of better job security in light of the massive layoffs in the
: Pharmaceutical industry and a path to a more rewarding career. I would like
: to throw in a few lines and some random thoughts, based on my limited
: understanding and light experience on RA, and hope to start a discussion
: that may benefit those who are interested in venturing into
|
g********n
发帖数: 4054 | 16 Labeling/promotion/advertising: public relations, business, and Law
SCIENTIFIC
【在 j******w 的大作中提到】
: 2) What background do I need in order to be successful in RA?
: Per sub-areas identified in 1), it is readily to identify what SCIENTIFIC
: background may be necessary to excel in that particular sub-area.
: 1) Clinical: medical/nursing/pharmacy/pharmacology/statistics
: 2) Regulatory strategy: none
: 3) Regulatory operations: none
: 4) CMC: chemistry and/or biology
: 5) QA/Compliance: chemistry/biology/process
: 6) PV: medical/nursing/pharmacy/pharmacology
: 7) Labeling/promotion/advertising: public relations, b
|
H**********J
发帖数: 351 | 17 你真热心！信息狠有用！赞一个！^_^
it
【在 j******w 的大作中提到】
: 1) What is regulatory affairs?
: Regulatory is a vast field. Everyone probably has their own understanding
: what regulatory affairs means, which functional divisions are included in it
: and what responsibilities it assumes.
: I personally think anything that operates under the mandates of a drug law
: and regulation is regulatory affairs. I have also divided RA into several
: sub-areas based on the specific functions, with the sole intention to
: conveniently illustrate the complexity of RA. They are probab
|
H**********J
发帖数: 351 | 18 拜耳北京在招RA Director,罗氏D的CMC部门筹建中，Formulation group leader、
Quality and Regulatory Compliance (QRC)、CMC Biologics-CII都是Open状态。 |
l****i
发帖数: 110 | 19 Are they looking for CMC or non-CMC RA?
Will US RA experience count? or are they looking for China RA experience.
【在 H**********J 的大作中提到】
: 拜耳北京在招RA Director,罗氏D的CMC部门筹建中，Formulation group leader、
: Quality and Regulatory Compliance (QRC)、CMC Biologics-CII都是Open状态。
|
H**********J
发帖数: 351 | 20 Global RA in Beijing China;non-CMC;
【在 l****i 的大作中提到】
: Are they looking for CMC or non-CMC RA?
: Will US RA experience count? or are they looking for China RA experience.
|
|
|
r******0
发帖数: 2753 | 21 Do you know what's the typical pay for this kind of position? Let's say,
Global RA manager/director level. (with 10-15 years US pharm. experience)
Thanks.
【在 H**********J 的大作中提到】
: Global RA in Beijing China;non-CMC;
|
H**********J
发帖数: 351 | 22 国内价钱100万-150万；也有一个人目前是30万美金。但他是唯一一个，也是不符合市
场行情的。
【在 r******0 的大作中提到】
: Do you know what's the typical pay for this kind of position? Let's say,
: Global RA manager/director level. (with 10-15 years US pharm. experience)
: Thanks.
|
l****i
发帖数: 110 | 23 Do they need PhD?
【在 H**********J 的大作中提到】
: 国内价钱100万-150万；也有一个人目前是30万美金。但他是唯一一个，也是不符合市
: 场行情的。
|
H**********J
发帖数: 351 | 24 No
【在 l****i 的大作中提到】
: Do they need PhD?
|
c*******u
发帖数: 88 | 25 in China, RA directors often spend most of their time having dinner and
phone calls with SFDA officials, while leaving all the paperwork preps to
their subordinates. |
