Scribd Logo
Upload

Welcome to Scribd!

  • Handouts Regulatory Affairs

    Uploaded by

    shyamasha
    13 views35 pages
    Good one

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document
    Good one

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    13 views35 pages

    Handouts Regulatory Affairs

    Uploaded by

    shyamasha
    Good one

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    of 35
    All inthe Details: Careers in Regulatory Science - Science Careers - Biotech, Pharmaceut... Page | of ‘ttp://sciencecareers.sciencemag.org css er Sie had spent ‘more than a docage 38a consti a federal pon whan she feces she wate something roe. A commissioned oe Ine Pubic Heath Service (htp-hwor sph gov). she Rad ion boon mtresid In public heath, ane she Rad Boon {ng about psy a mostere Segre ine fea Sa the ‘dscdodto go bak o schol for amestrs degre in puble ‘minis Wile woring onher mate's. cere, the opportunity aos {or chtoto mtenaw athe U.S Food and Brg ‘Admeitrtion pw fa gov? (FON), aed she fet ‘tetiwas peed tring’ te poston woud slow arto (dovetop har carer and expand er sks. Of her experience Ir graduate sees, se says 'gave me the conidence and {he tl to nerf a potion regulatory soc = ie se tasted hor dgtos the wrked at tha FDA Contr for Devices and Radiological Moai {htpsivonteagowediealbovicesdetaut.nm) for thom she reviened dena produto ensure hat tay he ‘mot al regulations dooming them ste and ofecive, _Snce ne, she has held jobs relating ovary often aspect of equity science, Suton Gaia Los Angie "Yove cong eseen, buyouts Soran a a Intpisciencecareetssciencemag.orgleareet magazine/previows issues/articles!2010 04 ea CTSciNet 3: Clinical and Translational Science Network, All in the Details: Careers in sj Regulatory Science Regulatory science "is the art and science of taking new medical and food products to market and keeping them on the market, under the constraints of a variety of laws and requirements. You're doing science, but you're doing it ina legal framework." --Frances Richmond (cay, Sante Sve Sareea Sie 1123/2010 All in the Deualls: Careers in Regulatory Science - Selence Careers - Biotech, Pharmaceut.. Page 2 of 5 Open opportunities In Febuary, deca tat ts ie to accelerate and Hurnate te pathway tom microscope to market" US. Ceparent fot Heath ana Human Servoes Secretary Katieen Sebel announced alangiark collaboration {hepsi fda govStencoRovearchpecla Topics RegultorySelenceldeauithin) between FDA and th Naor Irautoso Hea ogltaryaconen, The ages wa srr $75 mon rotor goo prota rode nea et, mses or eswcepes vat erauabg sty ard oeny Sag he deepen ec CTSciNet sey nk sneer Sec Hr] ‘Tis i part ofan aril sari for CTSNet (htp:teommunity slencecareors.orglctscnet the Cia end “Transitional Scene Network. anoninecorimuny. These aces are pushed on both Svcs Cavers a ‘within CTSeiNetPitpicommunly sclencecereereorgltacineartcle!) Regulatory science neides regulon ates, regustory itn, rk management compkance, ad egusory iw. Even, ‘Hep in Demodcal pect developmortsroguaiegrevearch and development pecrical aes, ccal she, he Fanufactag procs, marking, and posimarketng suvoliance So, «fellows ta roguatrysontss work seach one [nose steps, valang produ candies and Wil, heating ambng wereld pores, ding compromise and faring consensus ‘These days, the ek requie expertise tom sont in varity of icpines, incising phys, He scents, emits, ond engrsers FDA. artural ame fr regu aseret, ler employment mare han 30 ine ‘iecines, clang eeearch sconce, pharmacy, ase, vtecnary mode, nung nd nical edie. Besides ob opportunist agencies such FDA he companies developing biomesscl produce and devices employ rogultory-scence experts to ke sete company flowe al eglatone oh gucalne every prods nerery ‘unity wie apc wi be mareted, even boo th equator egoncios gots waves. Ana ‘Ender ke genoa conte ding al Be easy roc canals and sending to hard ones an enaodordt” Regus scence ban area hat usu has more obs than quaifled candidates, ‘Richmond say. Ane deraieconeobsaon nthe pharmaceutical due, the ‘raat or regulation stone genet stable ays Lawrence Ube Sxccstve desta ole CMR Intemational inate for Regulatory Science (hepa org n London ‘Some areas ar fang fa hor of lng obs. chm pos o global regultoy ‘hrs (peiculry pottons hat requre Spansh cr Japanese anguage sls). Somaners, and cagostetstng as afas at ee expocly tpped or Sppicass. Libor ooze tat he gobelaaton of egiston fe hgghng conn ‘Sh gs bang ual “Thee wil kay be on ereaing noe fa personnes who “iderstan net ony eal roguatr regurerpenis ut ao nematonal snd, ‘egioral languages and cutral settles, he says "Wiel eunded sents ‘who can intra glo enutonmant So gy Sout Fegistory sient are wo compansated.A2006 surrey (tpn saps og/PersenityEbusineas/Poral Documens/t7_oct06-p by the Reguatry Aftare Professionals Socity(ntpulwwocepe or) ooked st ssren and Gunde averobe say for PD. Rar 10 bo ‘bout $142,000 Teco wit bachelors gros eam abut S05, 000. nun: /sciencecareers.sciencemag.orwcarcer mavazine/previous issueslaticles/2010 04... 11/23/2010 All in the Details: Careers in Regulatory Science - Science Careers - Biotech, Pharmaceut... Page 3 of S Formalizing training Inthe 1960 and 18608, people waking in regulatory scien pial eared the Insane cua egatry work on he eb ~ bul nt neces at tego ‘agency. The was the exes fer USC's Micon Ate arnrg a PRD. owoahysigy Rtenord worked on sen of matr cool at Queens UUniverly (np queeneu.cal i Kegston, Canada whee se began ‘coating mptantable davons to stsaepaaleed males “To got an ‘raniabe deven onthe mart rover ao of fewtrg" chmod eae, "We Fad read aot and werk wth ruc, and praduay became ore Fesponetie for ht side of tings "Back ther, we had the grat ry of beng abe to ean the regaton and ows shay apboare so you could gradual bacome an expan she seve Toy. Rowever ere ae tr mote aw ae, nation fo mor and mere comp ‘Bence gong ino developing Suge” Although formal inne necessary Fequremert tere are a hand of programs aroun the coun Dat an to ge "ppicars sf rounding nega scones Totat enn Ocabe 2008 FDA accepted Hs st goup of 50 fous forthe Teacts: Hoceshansong) | commissioner Fellowship Program Frances Rltmord (nttpsn a gouiAbout /WorkingatF DAVFllowshipntershipGraduatFaculyPrograms!CommissionersFellow Sleced rom mere then 1000 applicants. Ong the 2-year program, flows aln al sn FOA fc king courses and coreg since reeearch project. Coureewor covers regulators, sence, nd poly. The program open {Sitentts who have a doctoal or profesional degree or engioe's who ave a bach degree In ado, FDA i parnorng wih univer rts COER Academic Collaboration Program (hp: ca gai About A/Workinga OA/rellowshipntonshipGraduatocultyProgrameluc 187708). Propams atthe Crversty of Fre Calloge of Pharmacy’ (per cop af dl SoparmentaPHC ANewetttraduatertusinProapectvestudensipeomasers. Min) ns [ASU Prosnits Callege of Nursing and Heath novation Sracical esoatencenrgustn sunset Fonaa teers recae years f nding toward srs of cscs {ogre or a.m pramacoutcal outcomes and pale research For She's program a ASU, which ke aod fo bogin in {a2 2010, he dope ea masters in egustory acence and heath salty. th programe equte ta sates be Commissioned ne US, Pubic Hea Seren ond cont work for FOA fora pected be ered afer rauaton, ‘oe pat alot traning occured win the FDA. says Grog Wood rector of he FOAs Acadeic Cotaboraton Progam But because sclance was edvancng at suc aap pecs, he aye Ul FDA aumniaton sow that we needed {o branch cut natalebrae wit academia to Tan pecple wh ore experiance and hand-on krewodge 0 tay oul Ite road ang” Jonas Santago Ize of va stunts athe est clas ofthe Fada progam, which began in January 2008. When he ‘gaduatoa fom cooper 2002 wn a goograpy dogo, Sartago had cre’ aepratone nto goverment str, bathe ‘ans hat ttenad federal purse sage Nad odo hag eezes mony Separment inetd Ne erred pramacy ‘schoo earings Pharm. om Howard Unversty in 2008 ‘During hs fourth yar clinical rotation weh FDA, Santiago lared of to collaboration between FDA ad the Univer of Foran’ Soe sofes ana was accepted. "There's alt soak research didnt know when veo one 8 desgn ‘orus anther orhow to scrutaze a sudyolook a ts song and woannesset "ho ays “The educaton i reantte prove graduates wih the sl Sto evaluat modcations risk managenentpoprams, nd her nabesiniorme of sai, eectrenese an cst. "Someimes you need someone undertard the hale fracess in oreo hap wih dace mating hesaye Tee glng ne ne ooo beter sucsed at FDA ad promote frrevaton tare." hnto//sciencecareers sciencemag.orulcareer magazine/orevious issues/articles/2010 04 .... 11/23/2010 ‘Allin the Details: Careers in Regulatory Seience - Science Careers - Biotech, Pharmacsut... Page 4 of S (Poss gio he est clas of he US. Food and Ong esearch (FDNICDER) Gragvate Tang Program atthe Getting into regulatory science “The auth eon or mor widespread forma education in regutry cience. Today, fewer than 30 U.S. univer (np: raps orgpersontyebusinesshabid76/Detautaspx) of masters daprees PhD, ocoreato, a wo Ss another hain Canada ard Euope ‘The USC program ors 2 masters degree, @ PLO. and several cericates. Grades of the program fx job easy Richmond sae, though OD of voles are seat employed and entre program o eae snd sharpen Del eis ‘They can complete the degres 9 fle opt sido many held Sn obs and sudy par tme (One of those was Mary Elen Cosenza, 2008 masters poyram graduate, Ate an undergraduate degre in blog ard ‘amis, Cosenza worked several beech and pharmaceutical companies mung a shor stk nroguatry acence inte mid: 18008 She every eared amasie’s degree and PhD. In tooology, werk a deo Labe ‘vironmental xcsiegy. Rect by Agen, she spent anaer doen yearn onagy bao scoleague asked her {move back no regu sowrce “By men, regultr ha undergone a wemendous change tom when Fé been nt anos 20 years befor” Cosenza sa ‘Themasiars program ip ron mothe new word: ha hw exscuve Greco arg mask ‘Amgoris Onion of nerratoral Regulatory Aas a Salty “manage people around the word, ax wel as cor group Bat puts fogs ings, product renewals, and product Iaboing she says "We ao ooking at process nprovenent, baer way odo tanga For exampl, whe she tate, {he counts under he purview had fo witen process expaning how foe a now aptaton 2 marking [Spplcalon. Now hay have manuals and pocenses lo ensire tha equation fe alowee Cosenza’ poston in emerging markets counties that have eceny begun to dustiaize— harbinger ofthe (Gebetzaton of gusty scnten The 2008 survey by he Regeltoy Afar Profesionae Soy fund tat mare an {eit of regulatory otecaonas nto United Slates ond Canada Rad mutational or gba respon, “Thesis equi for a egiston scence carer go beyond a sian background. Shi std analytics sas, ogotaing stl, end conmunation sts as beng kay. Itp-sciencecareerssciencemag.ora/career masazinelprevious issues/articles/2010 04 .. 11/23/2010 All in the Details: Careers in Regulatory Science - Science Careers - Biotech, Pharmaceut... Page 5 of S The poop essen who've been he most secessh ar not oly god slots bt io can gai consensus wal” Uber says "Thee ab personally component to regal scence] el oten gos oveockaa Regulloy eat ‘eed to Be good tener. Troy tera wih sales and markaing research, producer and al af owe grou seo @ ‘rblem om erent pol of view. she rogory scent nat neds fo ng consensus at port of ew Regulatory science resources Tags Ferdsnd ug Aémraton EO") manag an nfrmaton page about autre (ntp:twan a gow SetenceResearch Special TopicneguatrySeinceldetaut hn). whit cade he econ ‘Sonouncament ofthe FOANatona nett of ean colaboraton en rgusr and anaon! cence, _leewner on he FDA se, you can fe inermation about he CDER Academic Collaboration Program (om moat toning oAFalonhipnmehporeut! cal Prograraten 67S em) Sind'the Commasioners Fellows {htp:twon fa gov About DAWorkingatrDAVFllowshpintershipGradusteFacultyProgramsiCommissioneraFef ‘The Regulatory Afars Professionals Seeley (htp:Iwwntaps.or) (RAPS) prods stars wih inkrmaton on ‘gular ata, ncuaing ts Regulatory Career Aavancomom Gute {itpstwan aps. orppersonlyebusiness\CarerDevelopment Reguison CarearAdvancementGuidetabidt1 D4 RAPS marian ale of degree programe (np lve. raps ogpersonivebusinesshabid Default) ‘elated to rguatry sles, ncluang those n Ewope, Canasa, ane Ausra. Nancy Vokrs isa scence witerin Vermont. 10:126/ecence cred 21000097 bito:lsciencecareers.selencemae.orw/career magazinelorevious issues/asticles/2010 04... 11/23/2010 age 1 of L eniagrn, Su tyre secre ameenenonencnentn Newt the Profession Career Advancement Guide Lear, Grow. Suoseed temp pn ty + cua neta ‘ 7 RET eerste =m ERT nese — IG ‘See Gre Sei ate lev xe r ene era asteao _hut://www.raps.ore/personifvebusiness/tabid/t 1 16/Default. aspx 11/18/2010 ‘Who are regulatory professionals? Page Loft reer Advancement Guide Lewn, Geo, Succeed SRR nr Tartan http:/ www raps.ora/personifvebusiness/abid1138/Default.asox. ‘aneanio ‘Overview by ‘Iypical Fosition Titles for the New Regulatory Profession (Level I) Page | of | SESSA _ Qyerow by typical Postion 11s Career Advancement Guide Lean. Grow Succeed. aes Si nt et OE area nme nto://www.raos.ore/personifvebusinesa/tabid/I 139/Default.aspx 1itg2010 ‘Knowledge and Skills Page 1 of L sre ae SS RL rs sm ten acon hto://www.rans.ora/oersonifvebusiness/tabid’l 140/Default.asox 1182010 Knowledge and Skills Page Lof | Knowledge and Skis eee ‘htte://veww-rans.ors/ecesonifvebusiness/tabid/1 140/Default.asox 11/18/2010 Code of Ethics Page lof | a Ease Coaeof Ethics Career Advancement Guide Lean, Grow, Success. EN Pens re nte://www-rans.ors/ecrsonifvebusiness/tabid/1 19S/Default.asox 11182010 ‘Start Reading: Anicles and Books Page 1 of 2 Mere areer Advancement Guide Lean. Grow Succeed See Sac user Sortie era ie Tino cree tts eyntioe Sco ence eee, te ep ae a = Orc dca tn htp:/fwww raps ora/personifvebusiness/tabid/t 141/Defaulvaspx. 1igan10, Start Reading: Articles and Books Or pa cone some Sa” Repros one ‘hemiieww rans oreinarsonifvehusinessltahidlt 141/Pefanlt asme Page 2 0f 2 angio Education and ‘Taining Page 1 of 2 Soe Career Advancement Guide eam. Grow. Succes. gq mm Sas Se Skee. http raps org/personifyebusinesstabid/1142/Default aspx igang Education and Training Series Bettany Mente ee tte oy Egan ‘nto://www.raos.ora/versonifvebusiness/tabid/1 142/Default.aspx Page 2 0f2 1uige2010 Jah Information: Regulatory Affsirs Associate II Page | of 3 Tile Regulatory Affairs Associate Il ‘About the My company shares my ‘Organization Passion for helping to improve human health around the world.” “This is My Medimmune." Those who join Medimmune feel a sense of ownership about their future. “They Drive vith a recognized leader nthe biotechnology industry and the whly-owned subsilary of Astrazeneca plc. Here, you will join passionate professionals who advance slenoe, technology and meticin to develon products designed to help peone Iva bate ves. You wil cl inan envronment characterized by respec, rtegry and growth opportuni. that ‘encourages both invidualcontibulon and colaberawve enirepreneurial thinking. Our products andlor product candidates ere designed to aacress areas of need in infection, ‘oncology, respiratory disease and ilemmation,cardavascuargastointestnal Saease ‘and neuroscience. Explore a Madimmuno career as we sve o beter more Wes, more ‘fen, around the word. Description Tile: Regulatory Afairs Associate Il Location: MD, Gatersburg - Corporate Headquarters Reg: 02604 Position Summary: - Responsiie for colecton, preparaton and assembly of CMC documentation required {or US and RoW regulatory submissions (NDs, CTAS, IMPDs, BLAS, et) Work closely withthe Therapeute Area RA Lead to coordinate wih project teams in ‘reparation fo: regulatory mestngs, nlucing development of bling documents ans Presmeeing rehearsals, “Partcpates as te CMC Regulatory Mars represertatve on various project teams as assigned “Proactively identifies potential issues, and potential esolutons, and brings tem to the atertion of management. Major Duties and Responsiiites: CMC regulatory representative on assigned projec teams within and outside of Regulatory Mars. Participates onthe cossfunctonal CMC project teams, a8 assignee Performs unclons in suppor of CHC sections of regulatory submissions incuding preparation and intial review, complation of documents, coordination of review and ‘approval of documents, “interacts with Dovelopmert and Quality team members to ensure the timely preparation ‘ana receipt o ntermation required for regulatory submselon Interacts wit Terapeutc ‘Area RA represeniabves to ensure timelines are mel and CMC issues are communicated, Interacts with Regulatory Operations to ensure submission documents meet publishing requirements. * Create andlor administer Rogulatory CMC spreadsheets for racking agency feedback, ‘change control, CMC submissions, and others as needed “Responsible for maintaining and vacking CIC slbmssions in accordance with the ‘ttp:/medimmune sppone.com/MainInfoReq asp?R_ID=$01491&B ID-338ifid=1&Ad=... 11/4/2010 Job Information: Regulatory Afiairs Associate II Page 2 0f3 Position Requirements Educational Requirements ‘Company info hitp/imedimmnne appone com/MaininfoReq asp?R_ID=S014018B_ [D=338f ‘established regulator systems in coordination with Regulatory Operation staff Provides foacback on regulations and guidance documents to reguatry afas and project teams | "Reviews analyses to validate the conclusions of studies “educates intemal stakeholders on the Intent and implications of regulations “Assists in the planning, coordnation, and preparation of CMC meetings wih regulatory ‘agencies ‘Special Skis: Excellent oal and writen communication sil; {= Svong interpersonal /roup sls; capable of working colaboratively wih colleagues alfunctons| “'Selemotvated and aton-oented: “igh standard of prefeelona ethics, nteghty and wust, Excelent planning, organizational, and prorizing sil wth ably to mutta; + Consstenty high professional mage and demeanor, + Proficiency in the use of MS Word.¥, ExceL¥ and other approprate sofware programs. ob complexty + Familar with drupbologc development process. “Demonstvated aby fo dently Issues and intaive to recommend soluons. Abit to proniiz, multitask, and schedule work to mest deadines. Must be abe to ‘Produce high-qually dlverabios to moet tight deadlines and excel ina fast-paced team- (rented environment “Able to quickly assimilate nformaton and be flexible wth change, Able to Successtly interact wih al levels of he organization, Supervision: Rogues minimal instruction to ensure satisactry completion of routine work; with more specie instructions provided on new or unfair assignments. Workindepencenty Yo ‘secomplish high qualty submissions, Brings impedimentsichalenges tothe attention of Siponisor wel in advance of de daies Education: BSIMS ina scientific ciscitine. Experence: A minimum of 2 year of reasing documented success relevant to Regulatory Afar. Booharmaceutical or pharmaceutical work experience is Fighiy

    You might also like