s********g
发帖数: 91 | 1 如果没有工业就的工作经验，只做过薄厚，对于生物或者化学毕业的博士们，如果再去
读一个master of biomedical regulatory affairs 的学位，会不会好找工作些？看了
一下课程：regulatory affairs, quality assurence, clinical trials, project
management等等。因为是晚上的课程，所以可以边做研究边读，就是学费也得3万块。
想争得大家的意见，值不值得去投资一下？ | t**n
发帖数: 4365 | 2 多去工作网站看看职位要求吧。
【在 s********g 的大作中提到】
: 如果没有工业就的工作经验，只做过薄厚，对于生物或者化学毕业的博士们，如果再去
: 读一个master of biomedical regulatory affairs 的学位，会不会好找工作些？看了
: 一下课程：regulatory affairs, quality assurence, clinical trials, project
: management等等。因为是晚上的课程，所以可以边做研究边读，就是学费也得3万块。
: 想争得大家的意见，值不值得去投资一下？
| s********g
发帖数: 91 | 3 I searched for the related jobs, all of them need working experience.
It means there is no way for those without experience people? How to enter
this area? | a******y
发帖数: 44 | 4 最可行的办法，是你在工业界找一个工作先。最好是一个生物制剂公司，靠近
development的位置。取决于你现在本身的专业背景，如果和protein engineering相关
，有process control, quality control,quality analysis相关的经验更好。这样可
以先进cmc部门，慢慢转去做cmc regualtory.
如果你有医学的背景，就看看能不能在clinical development里面找一个位子。然后再
慢慢转过来。
公司的ra部门，一般是不可能要没有任何工作经验的。尤其是你只有学校实验室背景，
没有工业界背景的。
还有一个办法，就是你看看有没有小的专门给别人做regulatory affair consulting的
公司。如果你能进去从最基础的职位做起，一两年后有经验，就可以试着申请大公司的
位置了 | r******m
发帖数: 5550 | 5 阿，非常有用的建议呢。
我是生物硕士背景，在实验室作了很多immunology方面，animal cancer model得工作。
现在regulatory and Quality control得master要学完了。想找相关工作。
看来还是要先靠会的技术进公司阿。。
btw,那我再写简历的时候，即使是找research的工作，是不是也最好提下自己在
regulatory方面的背景呢
【在 a******y 的大作中提到】
: 最可行的办法，是你在工业界找一个工作先。最好是一个生物制剂公司，靠近
: development的位置。取决于你现在本身的专业背景，如果和protein engineering相关
: ，有process control, quality control,quality analysis相关的经验更好。这样可
: 以先进cmc部门，慢慢转去做cmc regualtory.
: 如果你有医学的背景，就看看能不能在clinical development里面找一个位子。然后再
: 慢慢转过来。
: 公司的ra部门，一般是不可能要没有任何工作经验的。尤其是你只有学校实验室背景，
: 没有工业界背景的。
: 还有一个办法，就是你看看有没有小的专门给别人做regulatory affair consulting的
: 公司。如果你能进去从最基础的职位做起，一两年后有经验，就可以试着申请大公司的
| T****8
发帖数: 505 | 6 It is very helpful to get the Reg. MS degree, such as the one offered by
Johns Hopkins. We have hired people just because of that degree. Of course,
you need citizenship or at least GC. | W********t
发帖数: 8514 | 7 This so called RA MS degree might be able to get you in the door, but is far
from enough to do RA job. You need real RA experience instead of a degree.
Don;t waste your $$, get in a R&D and start with some CMC work... You might
be better off. | T****8
发帖数: 505 | 8 I think it's a lot easier to start in RA than doing CMC for folks without a
Ph.D. But indeed, it's hard to get those kind of jobs without some
experience.
It's sort of ironic, so many people are looking for jobs and we are having
such a hard time to find people that qualify for the positions we have open.
far
might
【在 W********t 的大作中提到】
: This so called RA MS degree might be able to get you in the door, but is far
: from enough to do RA job. You need real RA experience instead of a degree.
: Don;t waste your $$, get in a R&D and start with some CMC work... You might
: be better off.
| W********t
发帖数: 8514 | 9 well, many people work on CMC sections without a Ph.D degree, granted, you
might need a Ph.D to lead a R&D team.For these people with biology
background, it is easier to start with science and a little RA mixed in at
1st.
Plus who's going to let someone without any RA exp doing a company's RA part
for example reviewing IND packages?
Based on my years in RA field, I think exp is more important than education.
a
open.
【在 T****8 的大作中提到】
: I think it's a lot easier to start in RA than doing CMC for folks without a
: Ph.D. But indeed, it's hard to get those kind of jobs without some
: experience.
: It's sort of ironic, so many people are looking for jobs and we are having
: such a hard time to find people that qualify for the positions we have open.
:
: far
: might
| T****8
发帖数: 505 | 10 To understand science in order to do CMC review takes years of education,
but getting started doing RA is whole lot easier. Just about anyone can do
it with some training. I have got RA director calling me from major firm
asking stupid entry level questions, but never from a CMC person. Of course
to be a good RA takes a lot of knowledge and skills. A good one can save
company tons of $$$ in the application process along,
part
education.
【在 W********t 的大作中提到】
: well, many people work on CMC sections without a Ph.D degree, granted, you
: might need a Ph.D to lead a R&D team.For these people with biology
: background, it is easier to start with science and a little RA mixed in at
: 1st.
: Plus who's going to let someone without any RA exp doing a company's RA part
: for example reviewing IND packages?
: Based on my years in RA field, I think exp is more important than education.
:
:
: a
| | | W********t
发帖数: 8514 | 11 Well, most people on this borad already have certain degree of biology or
medical background, for them, this is something they can use when they start
doing CMCs as soon as they land on a position; on other hand, it is true
that about everyone can do RA with some training, but we are only talking
about filling up forms and knowing procedures, that's about it., To be honest, I
do not call this type of work RA. A RA is supposed to set up Regulatory
strategy for firms and understand FDA regs deeply (meaning how to apply in
different situations and even with some work around). Most people think if
you can read English, than you can understand regs,this is not ture.
On other hand, why good RAs get paid over $100,000? why so many Ph.Ds want
to go in RA field, but counld not? is it because they do not have access to
FDA regs? is it because they can not read regs in English ( by the way, my
chinglish is very bad)? Is it because they do no tunderstand the nature of RA works and think that RA is just paper pusher with good pay, a big office, and a lot of free time? I am not trying to say which is better job between
RAs and scientic jobs, but if you want to go in this field, then you have to
think it though,other wise....
course
【在 T****8 的大作中提到】
: To understand science in order to do CMC review takes years of education,
: but getting started doing RA is whole lot easier. Just about anyone can do
: it with some training. I have got RA director calling me from major firm
: asking stupid entry level questions, but never from a CMC person. Of course
: to be a good RA takes a lot of knowledge and skills. A good one can save
: company tons of $$$ in the application process along,
:
: part
: education.
| T****8
发帖数: 505 | 12 Well,we are talking about getting started in RA and not a seasoned senior
here. This is not about planning IND strategy for efficient BLA approval, it
's about getting into RA field. Folks can get started in learning the basics
, such as preparing submission forms， learning preparing eCTD, global
submit, so start helping out these little things that will get you in the
door.
On the other hand, people can also think about getting into the facility
auditor job, which should pay even better than RA.
start
honest, I
【在 W********t 的大作中提到】
: Well, most people on this borad already have certain degree of biology or
: medical background, for them, this is something they can use when they start
: doing CMCs as soon as they land on a position; on other hand, it is true
: that about everyone can do RA with some training, but we are only talking
: about filling up forms and knowing procedures, that's about it., To be honest, I
: do not call this type of work RA. A RA is supposed to set up Regulatory
: strategy for firms and understand FDA regs deeply (meaning how to apply in
: different situations and even with some work around). Most people think if
: you can read English, than you can understand regs,this is not ture.
: On other hand, why good RAs get paid over $100,000? why so many Ph.Ds want
| s*****l
发帖数: 1844 | 13 Do not agree with you. Tell you the truth, doing these types of work,
foreigners do not have any edge over americans. One will fact fierce
competition from natives. As you probably know, few americans like to do
bench work, these are their dream areas.
Foreigner without working experience is difficult to get in.
it
basics
【在 T****8 的大作中提到】
: Well,we are talking about getting started in RA and not a seasoned senior
: here. This is not about planning IND strategy for efficient BLA approval, it
: 's about getting into RA field. Folks can get started in learning the basics
: , such as preparing submission forms， learning preparing eCTD, global
: submit, so start helping out these little things that will get you in the
: door.
: On the other hand, people can also think about getting into the facility
: auditor job, which should pay even better than RA.
:
: start
| W********t
发帖数: 8514 | 14 The pay for a entry level RA might be on par with the pay for a biologist.
if you become a so called seasoned biologist, your pay will be good too,
right? if so, why bother to change or start all over in a different field?
it takes years to become a reasoned RA, if yo have this many years on hand,
why not use it to make youself a seasoned biologist? both filed at seasoned
level are well paid.
it
basics
【在 T****8 的大作中提到】
: Well,we are talking about getting started in RA and not a seasoned senior
: here. This is not about planning IND strategy for efficient BLA approval, it
: 's about getting into RA field. Folks can get started in learning the basics
: , such as preparing submission forms， learning preparing eCTD, global
: submit, so start helping out these little things that will get you in the
: door.
: On the other hand, people can also think about getting into the facility
: auditor job, which should pay even better than RA.
:
: start
| T****8
发帖数: 505 | 15 I think in small firms, one may get to wear different hats, and in
situations like that, you can certainly try help out with RA works. You have
to start somewhere. Not sure about the native and foreigner arguments. I
have dealt with many RA people from small start up to big ones as Sanofi,
CSLB, Baxter and so on. I find in big firms,there are many foreigners doing
RA. There are also Chinese with so so English as director in RA in
multinational big pharma.
For people with science background and no RA experience but wants to get
into RA. I think teh RA MS degree is helpful to land that first job.
【在 s*****l 的大作中提到】
: Do not agree with you. Tell you the truth, doing these types of work,
: foreigners do not have any edge over americans. One will fact fierce
: competition from natives. As you probably know, few americans like to do
: bench work, these are their dream areas.
: Foreigner without working experience is difficult to get in.
:
: it
: basics
| W********t
发帖数: 8514 | | T****8
发帖数: 505 | 17 其实这经验不经验的，每个人的感觉都不大会一样。 不过看到生物版不少郁闷的科学
家， 我觉得大伙别一棵树上吊死， 念个RA的学位没什么坏处。现在给我多一倍的工钱
我也坚决不会再去卖苦力做R&D了。
【在 W********t 的大作中提到】
: 这末多经验之谈，楼主有点儿感觉了吗？
| W********t
发帖数: 8514 | 18 我多说两句，这些郁闷的科学家老是觉得没前途，可我得问一句，你们手里有什么真正
货真价实的东西吗？没有手里过硬的家伙，到哪儿都郁闷。您要真能真能研制出一个有
效的癌症疫苗，甭多了，有30%的治愈就成，我保证您不遇焖。在今天的生物研究中，
有多少DATA是过硬的？有意义的？
【在 T****8 的大作中提到】
: 其实这经验不经验的，每个人的感觉都不大会一样。 不过看到生物版不少郁闷的科学
: 家， 我觉得大伙别一棵树上吊死， 念个RA的学位没什么坏处。现在给我多一倍的工钱
: 我也坚决不会再去卖苦力做R&D了。
| c********g
发帖数: 1106 | 19 这不是个人的问题，在每人都被迫作螺丝钉的时代和环境里，生物实验室里的螺丝
钉尤其惨。
【在 W********t 的大作中提到】
: 我多说两句，这些郁闷的科学家老是觉得没前途，可我得问一句，你们手里有什么真正
: 货真价实的东西吗？没有手里过硬的家伙，到哪儿都郁闷。您要真能真能研制出一个有
: 效的癌症疫苗，甭多了，有30%的治愈就成，我保证您不遇焖。在今天的生物研究中，
: 有多少DATA是过硬的？有意义的？
| W********t
发帖数: 8514 | 20 同意， 点儿背就得赖社会。
【在 c********g 的大作中提到】
: 这不是个人的问题，在每人都被迫作螺丝钉的时代和环境里，生物实验室里的螺丝
: 钉尤其惨。
| | | T****8
发帖数: 505 | 21 关键是有没有走出自己的comfort zone的想法与行动。人挪活， 就是这个道理。
【在 c********g 的大作中提到】
: 这不是个人的问题，在每人都被迫作螺丝钉的时代和环境里，生物实验室里的螺丝
: 钉尤其惨。
| w******y
发帖数: 8040 | 22 都是senior,收入差别可能不是很大， 可稳定性差老远了
药厂里的老年生物学工作者的饭碗不容易保住
,
seasoned
【在 W********t 的大作中提到】
: The pay for a entry level RA might be on par with the pay for a biologist.
: if you become a so called seasoned biologist, your pay will be good too,
: right? if so, why bother to change or start all over in a different field?
: it takes years to become a reasoned RA, if yo have this many years on hand,
: why not use it to make youself a seasoned biologist? both filed at seasoned
: level are well paid.
:
: it
: basics
| W********t
发帖数: 8514 | 23 这一点我很同意， RA是一个积累性的工作， 经验愈多， 干的与轻松， 稳定性也越好。
【在 w******y 的大作中提到】
: 都是senior,收入差别可能不是很大， 可稳定性差老远了
: 药厂里的老年生物学工作者的饭碗不容易保住
:
: ,
: seasoned
|
|
