careers chamblee 2016 05 15 raps

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May 2015

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Andrea Chamblee, Esq., RACRegulatory Affairs Careers


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DisclaimerThese materials were written and

prepared by the authorin her private capacity.

No official support or endorsement by the Food and Drug Administration

is intendedor should be inferred.


Bio:Certified Regulatory Affairs Professional (RAC) 1993; First class of RAPS Fellows 2008.

Experiences across all regulated products with an emphasis on compliance, enforcement, and GxP.

JHU and GWU Adjunct Professor; Keck Graduate School lecturer.

Member MD, DC bars. RAPS Executive Development Program, Kellogg School, Northwestern University 2008.


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The iconic Barbie went from fashion plateto pilot…to veterinarian, pediatrician… to astronaut…military…


But there was no single clear career path for RA.


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RA is a career that evolved relatively recently, driven by people from other disciplines who were affected by the explosion of regulations from the New Deal agencies, especially after 1970. There was no single recognized pathway to Regulatory Affairs, and in fact, the discipline that a person studied before going into RA was — and is — a valuable asset to understanding and applying regulations.


People come to RA from a variety of areas

From a lab Another office in a company

Law

Graduate school RA

Medicine/clinical

Pharmacy

Engineering

None of the above


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The Skill set is varied.5/26/2016© Andrea Chamblee 2016 9

As with Barbie, the necessary accessories for an RA professional have changed significantly over time.


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Education – new degree programs in RA

Certification - Regulatory Affairs Professionals Society (RAPS) has multiple certifications

Publications – write articles (you get to interview newsmakers, stay current, and get noticed!)


Networking – keep up with colleagues, companies, changes in rules and policies

You can get there from here.


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Drug Information Association (DIA):www.diahome.orghttp://careercenter.diahome.org/jobs

RAPS job bank and guide: http://careerconnections.raps.org/

PDA http://careers.pda.org/

Food & Drug Law Institute/FDLI: www.fdli.orgFDLI’s Smartbrief www.smartbrief.com


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www.usajobs.gov/JobSearch/Search/GetResults?Keyword=FDA5/26/2016© Andrea Chamblee 2016 15

www.diahome.org

http://careercenter.diahome.org/jobs


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http://pda-jobs.jobtarget.com/jobseeker/search/results/

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http://regulatorycareers.raps.org/jobs/#/results/location=20993%2C500&resultsPerPage=12&noStem=false&titlesOnly=false&salary_open=false&showMoreOptions=false&sort=DISTANCE/1,true


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http://jobsearch.monster.com/search/?q=FDA-__28Food-and-Drug-Administration__29&where=20993__2C-Silver-Spring__2C-MD


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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


http://www.cafepharma.com/


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http://www.glassdoor.com



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• 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 count5/26/2016© Andrea Chamblee 2016 29

The Manager, Regulatory Affairs will serve as the primary regulatory representative to Project Teams for 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. Determine 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. Provide oversight and effectively manage any outsourced regulatory submissions. Conduct independent regulatory research.

Requirements: Qualified candidate possesses 2+ 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 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. Knowledge of ICH guidelines on preparation of clinical study reports, investigator brochures.


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Be mindful of the etiquette

http://jobsearch.about.com/cs/infointerviews/a/infointerview.htm


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• In person◦ Dress for the occasion◦ Use business cards◦ Don’t use first names until you are invited ◦ Everyone has time for coffee (offer to pay)◦ 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)


This money is a joke…


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Search USAjobs by agency: HHS>FDA https://my.usajobs.gov/JobSearch/Search/AdvancedSearchExample:

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


RequirementsDegree: 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; ORCombination 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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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. ORPh.D. or equivalent doctoral degree, if related OR3 full years of related progressively higher level graduate education leading to such a degree OREquivalent 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.


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 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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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 abilitiesAssociated 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.


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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Can you take a course? Easy after work seminars (local chapters) RAPS

www.raps.org/your-career/regulatory-career-advancement-guide.aspx

PDA www.pda.org/MainMenuCategory/Chapters.aspx

Day-long www.kgi.edu/Corporate-Partnerships/Corporate-Education.html

Week-long, semester-long? Seek a mentor?


You can study independently:◦ FDA website www.fda.gov/Training

FDA Tour www.eduneering.com/fileadmin/user/Multi-Media/FDA_demo_new/overview.htm

CDRH Learn: www.fda.gov/Training/CDRHLearn

CDER Learnwww.fda.gov/Training/CDRHLearn


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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/ Publications/AboutPublications

◦ RAPS: www.raps.org


Attend, observe relevant meetings FDA advisory committee, other

meetings◦ www.fda.gov/NewsEvents/Meetings

ConferencesWorkshops/◦ www.fda.gov/AdvisoryCommittees/

Calendar/

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Set up a “Saved Search”


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Leave blank


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Recent Search Results



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After you attach your resume…


Fill out the personal information


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But I’m not an expert!Are you sure?


QC/Lab – you determine, perform, analyze testing, exclude testing as appropriate. That is regulatory affairs.

• Legal – analyze and apply requirements of the law and regulations, prevent violations. That is regulatory affairs.

• Manufacturing – determine, perform, analyze compliant manufacturing procedures. That is regulatory affairs.

• Project management – meeting predetermined specifications.• Writing, relationship building . That is regulatory affairs.


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If you are qualified, you will be referred to the selecting official.If you are in the top 3 list of candidates, you should be interviewed



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Acrobat Document


Say Rational Approach Please-Rational 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, associate and commiserate.Do we really need permission for our mission ofsubmissions without omissions? So what do you say- ismanagement on board to support this huge E-ffort?Everything I know about being me- I learned inkindergarten. Be nice to others. Stay in line. Don’tpush. 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- Protector-Confidant that’s what I want.Hey Research…whassuppp?? What it is.Can I believe it is what you want it to be…? I’m not askin’ for muchOnly that the data be con—firm—a –tor—y.


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Timeline, blame line, what’s my line? Gantt chart-PERT chart - WHO art thou? Keep to the schedule- who 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?

I trust in the Science…And its collective intellect.A legacy such as this… What’s not to respect?


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 …

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 chincuz 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 obstaclenor 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)


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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 signature-but I can’t type with all this hypeMerge, but don’t get too hyper bout those links. Do you golf too?

We need to maintain a dialogue-but 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 advocate-but 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 too-now you can’t be rude you gotta include -- not exclude


Orphan drugs for orphans-do orphans really need all those drugs? Generics for much less… I wanna be like Mike.

It’s-omics… genomics, pharmacogenomics, toxico- genomics, pharmacotoxico-genomics, and metabon-omics, -and- icities… 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 /III-but not so fast- we don’t know it all-we 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 has been 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


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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).


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 responsibilitythat is no longer free since MDUFMA, FDAMA… way to go mama!

I studied for the RAC and got my certif-i-catenow I rate- hi 5! Education- education not another degree.Rah! Rah! The new RA Institute -now that’s for me.

Don’t be a jerk- you gotta network.RAPS is a great professional society for a small fee-congratulations 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 importantCOMMITMENTthat will make THE KEY DIFFERENCE in ensuringthe success of biologics, drug, and device development.

Sincerely yours…former Chair of the Board and Madam President.

And that’s a RAP!October 2003Dedicated 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 3/2001)Joy A. Cavagnaro, PhD, DABT, RAC

President. Access [email protected]

( Chair of the Board, RAPS 2002) 2003©


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careers chamblee 2016 05 15 raps

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