A slide show of career advice on how to find and apply for Federal and other Regulatory Affairs positions

1. Regulatory Affairs Careers
Andrea Chamblee, Esq., RAC
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2. How do I get to RA from here?
The iconic Barbie went from fashion plate
to Sky Girl to astronaut… to military, veterinarian, doctor…
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3. Evolution of RA
But there was no Regulatory Affairs Barbie…
There is no one clear career path for RA.
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4. Evolution of RA
From a lab
another office in a
company
law
pharmacy
Medicine/clinical
engineering
None of the above
Graduate school RA
People come to RA from a variety of areas
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5. Evolution of RA
The Skill set is varied.
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6. Evolution of RA
As with Barbie, the necessary
accessories for an RA professional
have changed significantly over time.
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7. Needs
•
Education – new degree programs in RA
• Certification Regulatory Affairs Professionals Society
(RAPS) has multiple certifications
•
Networking – keep up with colleagues, companies,
changes in rules and policies
• Writing – stay current, stay skilled, get published
You can get there from here.
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8. Job Hunting –
where are the sites?
Who has the job listings?
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9. Job Hunting sites
• Drug Information Association (DIA):
www.diahome.org http://careercenter.diahome.org/jobs
• Food and Drug Law Institute (FDLI): www.fdli.org
FDLI’s Smartbrief www.smartbrief.com
• PDA http://careers.pda.org/
• RAPS job bank and guide:
http://careerconnections.raps.org/
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10. Job hunting sites – USAjobs.com
https://www.usajobs.gov/JobSearch/Search/GetResults?Keyword=FDA
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11. www.diahome.org
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12. FDLI
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13. PDA
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14. RAPS
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15. RAPS – DC Metro
http://careerconnections.raps.org/jobs/#/results/location=20850%2C500&re
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16. Monster.com
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17. CareerBuilder.com
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18. LinkedIn.com
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19. Employers –
how to research them?
where are the sites?
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20. Researching employers
• Look at the company websites
• Read the news and trade press
• Look at SEC.gov filings
– Are they anticipating a product launch?
• Check FDA websites
–
–
–
–
Applications
Warning letters
Recalls
Citizen petitions
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21. Research - cafepharma
http://www.cafepharma.com/
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22. Employers –
who hires
entry level employees
in FDA Regulatory Affairs?
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23. Companies that hire entry level RA
• PAREXEL International http://www.parexel.com/
• Quintiles Transnational Corp. http://www.quintiles.com/
• PPD Consulting http://www.ppdconsulting.com/
• ERA Consulting Group http://www.eraconsulting.com/
• Medical Device Clinical Services – MDCI
www.mdci.com/
• Biologics Consulting Group http://www.biologicsconsulting.com/
• QPharma Corp http://www.qpharmacorp.com/
And too many more to count
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24. Relevant Information: typical for private industry
• Position Responsibilities:
• Requirements
The Manager, Regulatory Affairs will serve as the
primary regulatory representative to Project Teams
for assigned projects or products.
Provide guidance to Project Teams on steps
necessary to comply with newly enacted regulations
and guidelines.
Interact with Project Mangers at FDA, when
requested by supervisor.
In conjunction with supervisor, determines
regulatory requirements for clinical and pre-clinical
submissions to FDA for assigned investigational and
marketed products.
Review documents intended for submission to FDA
to assure compliance with regulatory standards.
For assigned projects, provide oversight and
effectively manage any regulatory submissions that
are outsourced.
Conduct independent regulatory research.
The qualified candidate will possess two or
more years regulatory experience in the
pharmaceutical industry or equivalent.
Advanced degree. Working knowledge of
drug development process (particularly
INDs and NDAs), drug laws, regulations,
guidelines, and regulatory submissions.
Good understanding of the FDA
organization. Good oral and written
communication skills including the ability to
discuss scientific/technical data and
regulatory requirements with senior
management and FDA personnel. Good
knowledge of ICH guidelines regarding
preparation of clinical study reports and
investigator brochures.
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25. What do I do when I find an
employer I want to work for?
Does it matter
if there is an opening?
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26. Informational Interviews
• Be mindful of the etiquette
http://jobsearch.about.com/cs/info
interviews/a/infointerview.htm
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27. Speaking of etiquette - it’s like an interview
• In person
– Dress for the occasion, use business cards
– Don’t use first names until you are invited to do so
– Honor timeframes – if you say you only want 15
minutes, STOP after 15 minutes.
(Let them invite you to take more of their time.)
• In correspondence
– Don’t always use email
– Use a complete signature (auto signature)
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28. I really want to work
for the government!
FDA, NIH, HHS
This money is a joke…
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29. www.fda.gov/AboutFDA/WorkingatFDA
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30. www.fda.gov/AboutFDA/WorkingatFDA/CareerDescriptions/ucm113286.htm
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31. FDA
Search USAjobs by agency: HHS>FDA
https://my.usajobs.gov/JobSearch/Search/AdvancedSearch
Example:
Consumer Safety Officer
Additional Duty Location Info: 1 vacancy - Rockville, MD
MAJOR DUTIES:
- Participate in the review & evaluation of evidence submitted for legal and
administrative actions for medical devices in support of recommendation to
Center for approval or disapproval of the action.
- Review, evaluate, and respond to a variety of inquiries involving FD&C Act.
Communicate current policies and/or the interpretation thereof or questions
regarding compliance activities of submissions.
- Plan, initiate, assign, and coordinate investigations of routine assignments
by the field office to follow-up on products incidents or problems.
SALARY RANGE: GS-7-13: 36,671.00 – 115,742 USD per year
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32. Relevant Information - typical job in FDA
Requirements
Degree: that included at least 30 semester hours in one or a combination of the
following: biological sciences, chemistry, pharmacy, physical sciences, food
technology, nutrition, medical science, engineering, epidemiology, veterinary
medical science, or related scientific fields that provided knowledge directly
related to consumer safety officer work. The 30 semester hours can include up to
8 semester hours in statistics, or course work that included the principles, theory,
or practical application of computers or computer programming; OR
Combination of education and experience--courses consisting of at least 30
semester hours in the fields of study described in A above, plus appropriate
experience or additional education.
AND
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33. Relevant Information - typical job in FDA
Requirements (con’t)
One yr of specialized experience that has equipped you with the particular
knowledge, skills, and abilities to perform successfully the duties of the position, and
that is typically in or related to the work of the position to be filled such as
experience in managing projects and communicating technical information. To be
creditable, specialized experience must have been equivalent to at least the GS-9
level in the Federal Government. OR
Ph.D. or equivalent doctoral degree, if related OR
3 full years of related progressively higher level graduate education leading to such
a degree OR
Equivalent combinations of related graduate education and specialized experience
Education completed in foreign colleges or universities may be used to meet the above requirements
if you can show that the foreign education is comparable to that received in an accredited educational
institution in the United States. It is your responsibility to provide such evidence when applying.
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34. Relevant Information - typical job in FDA
Other considerations:
– “Year In Grade” requirements – identify your “grade”
• Even if you’re not in a government job now – best guess
• Education can substitute for experience
–
Recent contracting out, “shared services” of HR at FDA
means:
• HR has no experience or expertise in evaluating
substitutions of education for experience;
• HR has no experience or expertise in evaluating special needs
for scientific disciplines;
• hiring officer may never know your resume was submitted.
You may need to call, lobby, use “Polite Persistence”
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35. Relevant Information - typical job in FDA
HOW YOU WILL BE EVALUATED:
You will be evaluated to determine if you meet the minimum qualifications
required; and on the extent to which your application shows that you possess
the knowledges, skills, and abilities Associated with this position as defined
below. When describing your knowledges, skills, and abilities, please be sure to
give examples and explain how often you used these skills, the complexity of
the knowledge you possessed, the level of the people you interacted with, the
sensitivity of the issues you handled, etc.
1. Knowledge of appropriate administrative and technical review processes
in order to support multi-disciplinary regulatory/scientific programs.
2. Ability to manage detailed projects.
3. Ability to communicate orally and in writing.
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36. Strategies for Federal jobs
• Don’t limit your government job search by
job title.
– There is no Regulatory Affairs job title in FDA.
• Be careful before you state in your
application question/answers that
you have no experience.
– Are you sure? Are you already regulatory?
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37. Strategies for satisfying FDA requirements
• Can you take a course?
Easy after work seminars (local chapters)
• RAPS
www.raps.org/your-career/regulatory-career-advancementguide.aspx
• PDA www.pda.org/MainMenuCategory/Chapters.aspx
• Day-long www.kgi.edu/CorporatePartnerships/Corporate-Education.html
• Week-long, semester-long?
• Seek a mentor?
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38. Strategies for Federal jobs
•
You can study independently:
– FDA website www.fda.gov/Training
• FDA Tour
www.eduneering.com/fileadmin/user/MultiMedia/FDA_demo_new/overview.htm
• CDRH Learn:
www.fda.gov/Training/CDRHLearn
• CDER Learn
www.fda.gov/Training/CDRHLearn
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39. Strategies for Federal jobs
• You can study independently:
– Books and articles
• Andrea’s wishlist on Amazon.com
www.amazon.com/registry/wishlist/1P5281QAGYTJQ
• DIA:
www.diahome.org/en/Resources/Public
ations/AboutPublications
• RAPS: www.raps.org
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40. Strategies for Federal jobs
Attend, observe relevant meetings
– FDA advisory committee, other
meetings
– www.fda.gov/NewsEvents/Meetings
ConferencesWorkshops/
– www.fda.gov/AdvisoryCommittees/C
alendar/
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41. Applying through USA Jobs
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42. Set up a “Saved Search”
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44. Leave blank
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45. Recent Search Results
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47. After you attach your resume…
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48. Fill out the personal information
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49. But I’m not an expert!
Are you sure?
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50. Can you truthfully rate yourself the highest? Consider your
transferable skills (Are you already experienced “regulatory”?)
• QC/Lab skills – determine, perform, analyze testing, exclude
testing as appropriate.
• Legal skills – analyze and apply requirements of the law and
regulations, prevent violations.
• Manufacturing skills – determine, perform, analyze compliant
manufacturing procedures.
• Project management skills – meeting predetermined
specifications
• Writing, relationship building skills always!
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51. Books
Books by Kathryn Troutman: www.amazon.com/KathrynTroutman/e/B0037F5HZS/ref=ntt_athr_dp_pel_1
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52. Ode to a Regulatory Professional
Acrobat Document
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53. Ode to a Professional
Say Rational Approach PleaseRational Approach Please.
Can anyone relate? (raise your hand).
I’m late, I’m late for a very important date.
It’s been so long since I’ve had a date.
Can anyone relate? (raise your hand).
Can’t wait to integrate, collaborate, Assoc
and commiserate.
Do we really need permission for our mission of
submissions without omissions? So what do you say- is
management on board to support this huge E-ffort?
Everything I know about being me- I learned in
kindergarten. Be nice to others. Stay in line. Don’t
push. Tell the truth. Don’t use bad language. Raise your hand if it’s an
emergency! Can anyone relate?
Oh--- yeah… (raise your hand). Mentor- ProtectorConfidant that’s what I want.
Timeline, blame line, what’s my line? Gantt chartPERT chart - WHO art thou? Keep to the schedulewho makes the schedule anyway?
Why, too bad, only 24 hours in a day.
Project team…what a scream! Sounds more like the
Tower of Babel. Who’s making all that rabble?
The language of technology is the key
but we’ll need a good translator to get this
product out the door –
then our stocks will really soar!
Case-by-case…science-based.
Science-based regulations.
We’re talking regulatory now not science.
Science is not compliance.
If no compliance can there be good science?
Hey Research…whassuppp?? What it is.
I trust in the Science…
Can I believe it is what you want it to be…?
And its collective intellect.
I’m not askin’ for much
Only that the data be con—firm—a –tor—y.
A legacy such as this…
What’s not to respect?
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54. Ode to a Professional
We’re ready for the dossier. but we haven’t picked the dose- eh? What’s up
doc? Case-by-case
it’s a race. BLA, NDA, PMA …someday- will all be prepared in a day.
No way. Not in my day.
Control control - quality control. Is this a big black hole?
Or just out of control? Can’t wait – but need to validate.
Specifications… out of spec what the heck?
Hit the deck.
It’s just that it’s hard to persuade those at FDA…
That the quality of the product is all that you say.
When the results we compile into the C of A…
Are not supported by a validated assay.
Knock knock. Who’s there? Let me in. Not by the hair o’my chinny chin chin
cuz I’m manufacturin.’
Then I’ll huff and I’ll puff and I’ll write you up –
for messin’ up and not compli- in’.
You’ll look for me when you get your 483.
Can any one relate? (raise your hand).
Don’t mean to be an obstacle
nor am I trying to be mean when I challenge your will.
Just facing the challenges to make our development plan accept-able.
Over and out….
A, B, C, D, E, F, GMP, GLP, GCP, GTP, GXP golly gee.
Are you listening to me? Are you listening to me?
We just got a consent decree. Now you’ll listen to me.
I’m finally –a VIP! And I’ll be able to RIP.
Can anyone relate? (raise your hand)
Globalized, harmonized, standardized –
CTDs not to be confused with MTDs or STDs.
But it’s becoming contagious.
Even computerized.
Watch for those viruses.
Electronic submissions, remote data entry…
electronic signaturebut I can’t type with all this hype
Merge, but don’t get too hyper bout those links.
Do you golf too?
We need to maintain a dialoguebut dialogue don’t mean no-monologue plus monologue. What’d
you say?
that you’re from the FDA
and you’re here today to help? Yeah!
We also said in God we trust everyone else bring the data. Let’s
play the Devil’s advocatebut the Devil is in the details.
Did you say you were the FDA?
Is that what the D stands for?
Can anyone relate?
(raise your hand)
Pediatric rule means kids are now cool.
Women in clinical trials toonow you can’t be rude you gotta include
not exclude
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55. Ode to a Professional
Orphan drugs for orphansdo orphans really need all those drugs? Generics for much
less…
I wanna be like Mike.
It’s-omics… genomics, pharmacogenomics, toxico- genomics,
pharmacotoxicogenomics, and metabon-omics, -andicities… immunotoxicity, repro- and carcino- genicity.
Serious AEs go to FDA, IRBs and DSMBs.
Rock’n and roll’n INDs are in.
Go fast track-Phase I/II /IIIbut not so fast- we don’t know it allwe got the phase IV- but...
now we’re being recalled. Can anyone relate? (raise your
hand)
You can stay in bed - it's telemed –clinical trials in style for bad hair
days. Declaration of Helsinki hasbeen the status quo… now
being revised –the question on the table is active or placebo.
Doctor, lawyer, Indian chief, patient’s rights are becoming more
important as they should be. Many are reaping the benefits
from patient advo -cacy.
CBER, CDER, CDRH- that’s where you go unless you don’t know
where to go then there are intercenter agreements –
combination products- product jurisdiction
combination products- product jurisdiction.
Whassup Ombudsman?
Have you seen the Budman?
Are you drinking? Ribbit ribbit. Can anyone
relate? (raise your hand)
I’d walk a mile not to get a Refuse to File.
Clinical Hold I’m told is gonna hold up makin'
all that gold. You need a checklist… you
can’t think? What are they thinking? You’re
asking if we do THIS will it be OK? It
depends on what THIS is… What were you
thinking?
Can anyone relate? (raise your hand).
Create a new version to create a diversion with
the new version. What perversion? Risk
sharing – sharing risk. It’s low- it’s mid- it’s
high- oh no- no go. Going going gone. Next
in line…
Quality, Safety, Efficacy we have all three.
You should have enough copies.
I just planted 1000 trees. Can’t agree? OK
so we go to advisory. How many cell phones
can you hide in one of these meetings
anyway? The final vote- 7 say yes and 6 say
no. Big help to the FDA. Now what? Can
anyone relate? (raise your hand).
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56. Ode to a Professional
They were searchin’ for quite awhile
and finally found a new comish.
Did you get your wish?
Science, regulation and consumer protection.
It’s a huge responsibility
that is no longer free since MDUFMA, FDAMA…
way to go mama!
I studied for the RAC and got my certif-i-cate
now I rate- hi 5!
Education- education not another degree.
Rah! Rah! The new RA Institute -now that’s for me.
October 2003
Dedicated to Rapper Jim Phelps, Esq.
for his 26 years of service as legal counsel
(first version presented at inaugural meeting of the
RAPS Baltimore/Washington Metro Area Chapter
March 2001)
Joy A. Cavagnaro, PhD, DABT, RAC
President
Access BIO
jcavagnaro@accessbio.com
( Chair of the Board,
Regulatory Affairs Professional Society 2002)
2003©
Don’t be a jerk- you gotta network.
RAPS is a great professional society for a small feecongratulations are in order for reaching its’ 25th anniversary.
So stay involved- everyone counts. So who’s in?
HANDS UP…
one, two, three… keep counting- It’s an important
COMMITMENT
that will make THE KEY DIFFERENCE in ensuring
the success of
biologics, drug, and device development.
Sincerely yours…former Chair of the Board
and Madam President.
And that’s a RAP!
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57. Good luck!
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