Careers chamblee 2013 10 20 raps


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

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Careers chamblee 2013 10 20 raps

  1. 1. Regulatory Affairs Careers Andrea Chamblee, Esq., RAC 1
  2. 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… 2
  3. 3. Evolution of RA But there was no Regulatory Affairs Barbie… There is no one clear career path for RA. 3
  4. 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 4
  5. 5. Evolution of RA The Skill set is varied. 5
  6. 6. Evolution of RA As with Barbie, the necessary accessories for an RA professional have changed significantly over time. 6
  7. 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. 7
  8. 8. Job Hunting – where are the sites? Who has the job listings? 8
  9. 9. Job Hunting sites • Drug Information Association (DIA): • Food and Drug Law Institute (FDLI): FDLI’s Smartbrief • PDA • RAPS job bank and guide: 9
  10. 10. Job hunting sites – 10
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  12. 12. FDLI 12
  13. 13. PDA 13
  14. 14. RAPS 14
  15. 15. RAPS – DC Metro 15
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  19. 19. Employers – how to research them? where are the sites? 19
  20. 20. Researching employers • Look at the company websites • Read the news and trade press • Look at filings – Are they anticipating a product launch? • Check FDA websites – – – – Applications Warning letters Recalls Citizen petitions 20
  21. 21. Research - cafepharma 21
  22. 22. Employers – who hires entry level employees in FDA Regulatory Affairs? 22
  23. 23. Companies that hire entry level RA • PAREXEL International • Quintiles Transnational Corp. • PPD Consulting • ERA Consulting Group • Medical Device Clinical Services – MDCI • Biologics Consulting Group • QPharma Corp And too many more to count 23
  24. 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. 24
  25. 25. What do I do when I find an employer I want to work for? Does it matter if there is an opening? 25
  26. 26. Informational Interviews • Be mindful of the etiquette interviews/a/infointerview.htm 26
  27. 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) 27
  28. 28. I really want to work for the government! FDA, NIH, HHS This money is a joke… 28
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  31. 31. FDA Search USAjobs by agency: HHS>FDA 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 31
  32. 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 32
  33. 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. 33
  34. 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” 34
  35. 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. 35
  36. 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? 36
  37. 37. Strategies for satisfying FDA requirements • Can you take a course? Easy after work seminars (local chapters) • RAPS • PDA • Day-long • Week-long, semester-long? • Seek a mentor? 37
  38. 38. Strategies for Federal jobs • You can study independently: – FDA website • FDA Tour • CDRH Learn: • CDER Learn 38
  39. 39. Strategies for Federal jobs • You can study independently: – Books and articles • Andrea’s wishlist on • DIA: ations/AboutPublications • RAPS: 39
  40. 40. Strategies for Federal jobs Attend, observe relevant meetings – FDA advisory committee, other meetings – ConferencesWorkshops/ – alendar/ 40
  41. 41. Applying through USA Jobs 41
  42. 42. Set up a “Saved Search” 42
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  44. 44. Leave blank 44
  45. 45. Recent Search Results 45
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  47. 47. After you attach your resume… 47
  48. 48. Fill out the personal information 48
  49. 49. But I’m not an expert! Are you sure? 49
  50. 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! 50
  51. 51. Books Books by Kathryn Troutman: 51
  52. 52. Ode to a Regulatory Professional Acrobat Document 52
  53. 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? 53
  54. 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 54
  55. 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). 55
  56. 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 ( 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! 56
  57. 57. Good luck! 57