{"id":602,"date":"2025-04-10T15:13:52","date_gmt":"2025-04-10T15:13:52","guid":{"rendered":"https:\/\/karierawfarmacji.pl\/?p=602"},"modified":"2025-04-14T17:29:24","modified_gmt":"2025-04-14T17:29:24","slug":"regulatory-affairs-director","status":"publish","type":"post","link":"https:\/\/karierawfarmacji.pl\/en\/regulatory-affairs-director\/","title":{"rendered":"Regulatory Affairs Director"},"content":{"rendered":"<h2 class=\"wp-block-heading\">Regulatory Affairs<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Dzia\u0142y <a href=\"https:\/\/karierawfarmacji.pl\/en\/product\/kurs-on-line-specjalista-ds-rejestracji-lekow\/\">Regulatory Affairs<\/a> (RA), czyli dzia\u0142y rejestracji lek\u00f3w, s\u0105 odpowiedzialne za przygotowanie dokument\u00f3w potrzebnych do rozpocz\u0119cia oraz finalizacji procedury rejestracyjnej leku. Pracownicy dzia\u0142\u00f3w Regulatory Affairs s\u0105 odpowiedzialne za dostarczanie wniosk\u00f3w o przed\u0142u\u017cenie dopuszczenia do obrotu produktu leczniczego w terminie, a tak\u017ce wykonywanie odpowiednich czynno\u015bci w przypadku jego wycofania.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Regulatory Affairs Director<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Uda\u0142o si\u0119! Zaproponowano Ci stanowisko Dyrektora Dzia\u0142u Rejestracji Lek\u00f3w!<br>Jest to najwy\u017csze i najbardziej odpowiedzialne stanowisko przy Rejestracji Lek\u00f3w.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Dla formalno\u015bci wymagania podj\u0119cia pracy jako Regulatory Affairs Director to wykszta\u0142cenie wy\u017csze o profilu medycznym, farmaceutycznym, biologicznym lub pokrewnym, dobra znajomo\u015b\u0107 polskich i europejskich przepis\u00f3w w zakresie prawa farmaceutycznego, bardzo dobra znajomo\u015b\u0107 j\u0119zyka angielskiego, praktyczna znajomo\u015bci program\u00f3w MS Office (Word, Excel, Power Point), a tak\u017ce znajomo\u015b\u0107 lokalnych i europejskich przepis\u00f3w dotycz\u0105cych uzyskania pozwole\u0144 na prowadzenie bada\u0144 klinicznych.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ka\u017cda osoba na podobnym stanowisku to osoba o doskona\u0142ych umiej\u0119tno\u015bciach przyw\u00f3dczych, do\u015bwiadczona w zarz\u0105dzaniu lud\u017ami. Posiadaj\u0105ca \u015bwietne umiej\u0119tno\u015bci analityczne, umiej\u0119tno\u015bci pracy pod presj\u0105,oraz&nbsp; na stresuj\u0105cymi i odpowiedzialnym stanowisku.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Oczywi\u015bcie wymagane jest r\u00f3wnie\u017c minimum 8-10 letnie do\u015bwiadczenie w bran\u017cy RA, minimum 4 lata do\u015bwiadczenia w zarz\u0105dzaniu (wysoce preferowane jest do\u015bwiadczenie w zarz\u0105dzaniu RA), oraz pierwsze\u0144stwo maj\u0105 osoby pe\u0142ni\u0105ce wcze\u015bniej funkcje RA Coordinatora.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><a href=\"https:\/\/karierawfarmacji.pl\/en\/kurs\/zmiany-porejestracyjne\/?utm_source=kwf&amp;utm_medium=blogpost&amp;utm_campaign=regulatory_affairs_director\"><img decoding=\"async\" src=\"https:\/\/karierawfarmacji.pl\/wp-content\/uploads\/2024\/02\/Kopia-5C2751-1-1.png\" alt=\"\"\/><\/a><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Jako Regulatory Affairs Director Twoje obowi\u0105zki to:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">&#8211; Krytyczna ocena ca\u0142ej dokumentacji rejestracyjnej<br>&#8211; Przegl\u0105danie i zatwierdzanie protoko\u0142\u00f3w, raport\u00f3w i dokument\u00f3w rejestracyjnych<br>&#8211; Planowanie harmonogram\u00f3w poszczeg\u00f3lnych projekt\u00f3w RA<br>&#8211; Bie\u017c\u0105ce rozwi\u0105zywanie problem\u00f3w<br>&#8211; Nadzorowanie wsp\u00f3\u0142pracy dzia\u0142u RA z innymi pionami<br>&#8211; Nadz\u00f3r nad bud\u017cetem, zasobami dzia\u0142u, udzia\u0142 w rekrutacji<br>&#8211; Wsp\u00f3\u0142praca z RA Directors innych jednostek i funkcja reprezentacyjna w takich kontaktach<br>&#8211; Zapewnia profesjonalizm, najwy\u017csz\u0105 jako\u015b\u0107 us\u0142ug w zakresie RA oraz sta\u0142e szkolenie swoich pracownik\u00f3w<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><a href=\"https:\/\/karierawfarmacji.pl\/en\/rejestrlek\/\">Sprawd\u017a r\u00f3wnie\u017c opisy innych stanowisk&nbsp;<\/a>!<\/h4>","protected":false},"excerpt":{"rendered":"<p>Regulatory Affairs Dzia\u0142y Regulatory Affairs (RA), czyli dzia\u0142y rejestracji lek\u00f3w, s\u0105 odpowiedzialne za przygotowanie dokument\u00f3w potrzebnych do rozpocz\u0119cia oraz finalizacji procedury rejestracyjnej leku. Pracownicy dzia\u0142\u00f3w Regulatory Affairs s\u0105 odpowiedzialne za dostarczanie wniosk\u00f3w o przed\u0142u\u017cenie dopuszczenia do obrotu produktu leczniczego w terminie, a tak\u017ce wykonywanie odpowiednich czynno\u015bci w przypadku jego wycofania. Regulatory Affairs Director Uda\u0142o si\u0119! [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":2466,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_angie_page":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"page_builder":"","_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[39],"tags":[42,46],"class_list":["post-602","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-rejestracja-lekow-kategoria","tag-kariera","tag-stanowiska-badania-kliniczne"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Regulatory Affairs Director - Kariera w farmacji<\/title>\n<meta name=\"description\" content=\"Dowiedz si\u0119 wi\u0119cej o roli Dyrektora Dzia\u0142u Rejestracji Lek\u00f3w. 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