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Technical Associate, CMC Regulatory affairs

Genpact

0 - 3 years

Hyderabad

Posted: 17/12/2024

Job Description

Responsibilities

  • Labelling variations: preparation of local documents, Cover Letter, electronical application form, update of German product information texts

  • CMC variations: content check of documents provided by CMC (e.g. Cover Letter, electronical application form); adding local information, update in Submission content plan

  • Creation & maintenance of Veeva activities such as ROs, Submissions, Registrations etc in Veeva Vault before/after Submission/ Approval

  • Maintaining the related trackers and update the information accordingly.

  • Plan the due dates and coordinate the on-time delivery of the document, to meet regulatory submission timelines.

  • Preparation and alignment of Product information texts with medical + PV + Information Officer

  • Coordination of artwork implementation updates including annotations, proof-reading and approval (VISTA link)

  • Coordination of purely national labelling variations and preparation

  • Updates and upload of product information texts to Veeva Vault

  • Coordination of RA activities (dispatched dossier (download the dossiers from Veeva and coordinate with partner/stake holders) including QC of the dossiers & compliance with local regulations + all Veeva management activities

  • HA interaction + Post approval commitment + Regulatory intelligence coordination with Partners (distributors)\u003C/span>\u003C/p> \u003C/div> \u003Cdiv class=\"ListContainerWrapper SCXW112975816 BCX0\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative;\"> \u003Cul class=\"BulletListStyle1 SCXW112975816 BCX0\" role=\"list\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; list-style-type: disc; cursor: text; font-family: verdana; overflow: visible;\"> \u003Cli aria-setsize=\"-1\" class=\"OutlineElement Ltr SCXW112975816 BCX0\" data-aria-level=\"1\" data-aria-posinset=\"1\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"\",\"469777815\":\"hybridMultilevel\"}' data-listid=\"2\" role=\"listitem\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 0px 24px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; display: block; font-size: 11pt; font-family: Georgia, Georgia_MSFontService, serif; vertical-align: baseline;\"> \u003Cp aria-level=\"3\" class=\"Paragraph SCXW112975816 BCX0\" paraeid=\"{b85a8063-6929-425c-b0e5-8aa1695573e7}{100}\" paraid=\"723466965\" role=\"heading\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: rgb(15, 71, 97); text-align: left; text-indent: 0px;\">\u003Cspan class=\"TextRun SCXW112975816 BCX0\" data-contrast=\"none\" lang=\"EN-US\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; color: rgb(0, 0, 0); font-size: 11pt; line-height: 17px; font-family: Georgia, Georgia_EmbeddedFont, Georgia_MSFontService, serif;\" xml:lang=\"EN-US\">\u003Cspan class=\"NormalTextRun SCXW112975816 BCX0\" data-ccp-parastyle=\"heading 3\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">Labelling variations: preparation of local documents, Cover Letter, electronical application form, update of German product information texts\u003C/span>\u003C/span>\u003Cspan class=\"EOP SCXW112975816 BCX0\" data-ccp-props='{\"134245418\":true,\"134245529\":true,\"201341983\":0,\"335559738\":160,\"335559739\":80,\"335559740\":240}' style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 11pt; line-height: 17px; font-family: Georgia, Georgia_EmbeddedFont, Georgia_MSFontService, serif; color: rgb(0, 0, 0);\">\u003C/span>\u003C/p> \u003C/li> \u003C/ul> \u003C/div> \u003Cdiv class=\"ListContainerWrapper SCXW112975816 BCX0\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative;\"> \u003Cul class=\"BulletListStyle1 SCXW112975816 BCX0\" role=\"list\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; list-style-type: disc; cursor: text; font-family: verdana; overflow: visible;\"> \u003Cli aria-setsize=\"-1\" class=\"OutlineElement Ltr SCXW112975816 BCX0\" data-aria-level=\"1\" data-aria-posinset=\"2\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"\",\"469777815\":\"hybridMultilevel\"}' data-listid=\"2\" role=\"listitem\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 0px 24px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; display: block; font-size: 11pt; font-family: Georgia, Georgia_MSFontService, serif; vertical-align: baseline;\"> \u003Cp aria-level=\"3\" class=\"Paragraph SCXW112975816 BCX0\" paraeid=\"{b85a8063-6929-425c-b0e5-8aa1695573e7}{106}\" paraid=\"1746979316\" role=\"heading\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: rgb(15, 71, 97); text-align: left; text-indent: 0px;\">\u003Cspan class=\"TextRun SCXW112975816 BCX0\" data-contrast=\"none\" lang=\"EN-US\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; color: rgb(0, 0, 0); font-size: 11pt; line-height: 17px; font-family: Georgia, Georgia_EmbeddedFont, Georgia_MSFontService, serif;\" xml:lang=\"EN-US\">\u003Cspan class=\"NormalTextRun SCXW112975816 BCX0\" data-ccp-parastyle=\"heading 3\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">CMC variations: content check of documents provided by CMC (\u003C/span>\u003Cspan class=\"NormalTextRun SCXW112975816 BCX0\" data-ccp-parastyle=\"heading 3\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">e.g.\u003C/span>\u003Cspan class=\"NormalTextRun SCXW112975816 BCX0\" data-ccp-parastyle=\"heading 3\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> Cover Letter, electronical application form); adding local information, update in Submission content plan\u003C/span>\u003C/span>\u003Cspan class=\"EOP SCXW112975816 BCX0\" data-ccp-props='{\"134245418\":true,\"134245529\":true,\"201341983\":0,\"335559738\":160,\"335559739\":80,\"335559740\":240}' style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 11pt; line-height: 17px; font-family: Georgia, Georgia_EmbeddedFont, Georgia_MSFontService, serif; color: rgb(0, 0, 0);\">\u003C/span>\u003C/p> \u003C/li> \u003C/ul> \u003C/div> \u003Cdiv class=\"ListContainerWrapper SCXW112975816 BCX0\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative;\"> \u003Cul class=\"BulletListStyle1 SCXW112975816 BCX0\" role=\"list\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; list-style-type: disc; cursor: text; font-family: verdana; overflow: visible;\"> \u003Cli aria-setsize=\"-1\" class=\"OutlineElement Ltr SCXW112975816 BCX0\" data-aria-level=\"1\" data-aria-posinset=\"3\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"\",\"469777815\":\"hybridMultilevel\"}' data-listid=\"2\" role=\"listitem\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 0px 24px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; display: block; font-size: 11pt; font-family: Georgia, Georgia_MSFontService, serif; vertical-align: baseline;\"> \u003Cp aria-level=\"3\" class=\"Paragraph SCXW112975816 BCX0\" paraeid=\"{b85a8063-6929-425c-b0e5-8aa1695573e7}{112}\" paraid=\"1290834792\" role=\"heading\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: rgb(15, 71, 97); text-align: left; text-indent: 0px;\">\u003Cspan class=\"TextRun SCXW112975816 BCX0\" data-contrast=\"none\" lang=\"EN-US\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; color: rgb(0, 0, 0); font-size: 11pt; line-height: 17px; font-family: Georgia, Georgia_EmbeddedFont, Georgia_MSFontService, serif;\" xml:lang=\"EN-US\">\u003Cspan class=\"NormalTextRun SCXW112975816 BCX0\" data-ccp-parastyle=\"heading 3\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">Creation & maintenance of Veeva activities such as ROs, Submissions, Registrations \u003C/span>\u003Cspan class=\"NormalTextRun SpellingErrorV2Themed SCXW112975816 BCX0\" data-ccp-parastyle=\"heading 3\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; background-position: 0px 100%; background-repeat: repeat-x; background-image: var(--urlSpellingErrorV2,); border-bottom: 1px solid transparent;\">etc\u003C/span>\u003Cspan class=\"NormalTextRun SCXW112975816 BCX0\" data-ccp-parastyle=\"heading 3\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> in Veeva Vault before/after Submission/ Approval\u003C/span>\u003C/span>\u003Cspan class=\"EOP SCXW112975816 BCX0\" data-ccp-props='{\"134245418\":true,\"134245529\":true,\"201341983\":0,\"335559738\":160,\"335559739\":80,\"335559740\":240}' style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 11pt; line-height: 17px; font-family: Georgia, Georgia_EmbeddedFont, Georgia_MSFontService, serif; color: rgb(0, 0, 0);\">\u003C/span>\u003C/p> \u003C/li> \u003C/ul> \u003C/div> \u003Cdiv class=\"ListContainerWrapper SCXW112975816 BCX0\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative;\"> \u003Cul class=\"BulletListStyle1 SCXW112975816 BCX0\" role=\"list\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; list-style-type: disc; cursor: text; font-family: verdana; overflow: visible;\"> \u003Cli aria-setsize=\"-1\" class=\"OutlineElement Ltr SCXW112975816 BCX0\" data-aria-level=\"1\" data-aria-posinset=\"4\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"\",\"469777815\":\"hybridMultilevel\"}' data-listid=\"2\" role=\"listitem\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 0px 24px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; display: block; font-size: 11pt; font-family: Georgia, Georgia_MSFontService, serif; vertical-align: baseline;\"> \u003Cp aria-level=\"3\" class=\"Paragraph SCXW112975816 BCX0\" paraeid=\"{b85a8063-6929-425c-b0e5-8aa1695573e7}{122}\" paraid=\"1146348898\" role=\"heading\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: rgb(15, 71, 97); text-align: left; text-indent: 0px;\">\u003Cspan class=\"TextRun SCXW112975816 BCX0\" data-contrast=\"none\" lang=\"EN-US\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; color: rgb(0, 0, 0); font-size: 11pt; line-height: 17px; font-family: Georgia, Georgia_EmbeddedFont, Georgia_MSFontService, serif;\" xml:lang=\"EN-US\">\u003Cspan class=\"NormalTextRun SCXW112975816 BCX0\" data-ccp-parastyle=\"heading 3\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">Maintaining the related trackers and \u003C/span>\u003Cspan class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW112975816 BCX0\" data-ccp-parastyle=\"heading 3\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; background-position: 0px 100%; background-repeat: repeat-x; background-image: var(--urlContextualSpellingAndGrammarErrorV2,); border-bottom: 1px solid transparent;\">update\u003C/span>\u003Cspan class=\"NormalTextRun SCXW112975816 BCX0\" data-ccp-parastyle=\"heading 3\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> the information accordingly.\u003C/span>\u003C/span>\u003Cspan class=\"EOP SCXW112975816 BCX0\" data-ccp-props='{\"134245418\":true,\"134245529\":true,\"201341983\":0,\"335559738\":160,\"335559739\":80,\"335559740\":240}' style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 11pt; line-height: 17px; font-family: Georgia, Georgia_EmbeddedFont, Georgia_MSFontService, serif; color: rgb(0, 0, 0);\">\u003C/span>\u003C/p> \u003C/li> \u003C/ul> \u003C/div> \u003Cdiv class=\"ListContainerWrapper SCXW112975816 BCX0\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative;\"> \u003Cul class=\"BulletListStyle1 SCXW112975816 BCX0\" role=\"list\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; list-style-type: disc; cursor: text; font-family: verdana; overflow: visible;\"> \u003Cli aria-setsize=\"-1\" class=\"OutlineElement Ltr SCXW112975816 BCX0\" data-aria-level=\"1\" data-aria-posinset=\"5\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"\",\"469777815\":\"hybridMultilevel\"}' data-listid=\"2\" role=\"listitem\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 0px 24px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; display: block; font-size: 11pt; font-family: Georgia, Georgia_MSFontService, serif; vertical-align: baseline;\"> \u003Cp aria-level=\"3\" class=\"Paragraph SCXW112975816 BCX0\" paraeid=\"{b85a8063-6929-425c-b0e5-8aa1695573e7}{128}\" paraid=\"1637067252\" role=\"heading\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: rgb(15, 71, 97); text-align: left; text-indent: 0px;\">\u003Cspan class=\"TextRun SCXW112975816 BCX0\" data-contrast=\"none\" lang=\"EN-US\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; color: rgb(0, 0, 0); font-size: 11pt; line-height: 17px; font-family: Georgia, Georgia_EmbeddedFont, Georgia_MSFontService, serif;\" xml:lang=\"EN-US\">\u003Cspan class=\"NormalTextRun SCXW112975816 BCX0\" data-ccp-parastyle=\"heading 3\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">Plan the due dates and coordinate the on-time delivery of the document, to meet regulatory submission timelines.\u003C/span>\u003C/span>\u003Cspan class=\"EOP SCXW112975816 BCX0\" data-ccp-props='{\"134245418\":true,\"134245529\":true,\"201341983\":0,\"335559738\":160,\"335559739\":80,\"335559740\":240}' style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 11pt; line-height: 17px; font-family: Georgia, Georgia_EmbeddedFont, Georgia_MSFontService, serif; color: rgb(0, 0, 0);\">\u003C/span>\u003C/p> \u003C/li> \u003C/ul> \u003C/div> \u003Cdiv class=\"ListContainerWrapper SCXW112975816 BCX0\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative;\"> \u003Cul class=\"BulletListStyle1 SCXW112975816 BCX0\" role=\"list\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; list-style-type: disc; cursor: text; font-family: verdana; overflow: visible;\"> \u003Cli aria-setsize=\"-1\" class=\"OutlineElement Ltr SCXW112975816 BCX0\" data-aria-level=\"1\" data-aria-posinset=\"6\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"\",\"469777815\":\"hybridMultilevel\"}' data-listid=\"2\" role=\"listitem\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 0px 24px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; display: block; font-size: 11pt; font-family: Georgia, Georgia_MSFontService, serif; vertical-align: baseline;\"> \u003Cp aria-level=\"3\" class=\"Paragraph SCXW112975816 BCX0\" paraeid=\"{b85a8063-6929-425c-b0e5-8aa1695573e7}{134}\" paraid=\"2028728108\" role=\"heading\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: rgb(15, 71, 97); text-align: left; text-indent: 0px;\">\u003Cspan class=\"TextRun SCXW112975816 BCX0\" data-contrast=\"none\" lang=\"EN-US\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; color: rgb(0, 0, 0); font-size: 11pt; line-height: 17px; font-family: Georgia, Georgia_EmbeddedFont, Georgia_MSFontService, serif;\" xml:lang=\"EN-US\">\u003Cspan class=\"NormalTextRun SCXW112975816 BCX0\" data-ccp-parastyle=\"heading 3\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">Preparation and alignment of Product information texts with medical + PV + Information Officer\u003C/span>\u003C/span>\u003Cspan class=\"EOP SCXW112975816 BCX0\" data-ccp-props='{\"134245418\":true,\"134245529\":true,\"201341983\":0,\"335559738\":160,\"335559739\":80,\"335559740\":240}' style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 11pt; line-height: 17px; font-family: Georgia, Georgia_EmbeddedFont, Georgia_MSFontService, serif; color: rgb(0, 0, 0);\">\u003C/span>\u003C/p> \u003C/li> \u003C/ul> \u003C/div> \u003Cdiv class=\"ListContainerWrapper SCXW112975816 BCX0\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative;\"> \u003Cul class=\"BulletListStyle1 SCXW112975816 BCX0\" role=\"list\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; list-style-type: disc; cursor: text; font-family: verdana; overflow: visible;\"> \u003Cli aria-setsize=\"-1\" class=\"OutlineElement Ltr SCXW112975816 BCX0\" data-aria-level=\"1\" data-aria-posinset=\"7\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"\",\"469777815\":\"hybridMultilevel\"}' data-listid=\"2\" role=\"listitem\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 0px 24px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; display: block; font-size: 11pt; font-family: Georgia, Georgia_MSFontService, serif; vertical-align: baseline;\"> \u003Cp aria-level=\"3\" class=\"Paragraph SCXW112975816 BCX0\" paraeid=\"{b85a8063-6929-425c-b0e5-8aa1695573e7}{140}\" paraid=\"239295655\" role=\"heading\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: rgb(15, 71, 97); text-align: left; text-indent: 0px;\">\u003Cspan class=\"TextRun SCXW112975816 BCX0\" data-contrast=\"none\" lang=\"EN-US\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; color: rgb(0, 0, 0); font-size: 11pt; line-height: 17px; font-family: Georgia, Georgia_EmbeddedFont, Georgia_MSFontService, serif;\" xml:lang=\"EN-US\">\u003Cspan class=\"NormalTextRun SCXW112975816 BCX0\" data-ccp-parastyle=\"heading 3\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">Coordination of artwork implementation updates including annotations, \u003C/span>\u003Cspan class=\"NormalTextRun SCXW112975816 BCX0\" data-ccp-parastyle=\"heading 3\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">proof-reading\u003C/span>\u003Cspan class=\"NormalTextRun SCXW112975816 BCX0\" data-ccp-parastyle=\"heading 3\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\"> and approval (VISTA link)\u003C/span>\u003C/span>\u003Cspan class=\"EOP SCXW112975816 BCX0\" data-ccp-props='{\"134245418\":true,\"134245529\":true,\"201341983\":0,\"335559738\":160,\"335559739\":80,\"335559740\":240}' style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 11pt; line-height: 17px; font-family: Georgia, Georgia_EmbeddedFont, Georgia_MSFontService, serif; color: rgb(0, 0, 0);\">\u003C/span>\u003C/p> \u003C/li> \u003C/ul> \u003C/div> \u003Cdiv class=\"ListContainerWrapper SCXW112975816 BCX0\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative;\"> \u003Cul class=\"BulletListStyle1 SCXW112975816 BCX0\" role=\"list\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; list-style-type: disc; cursor: text; font-family: verdana; overflow: visible;\"> \u003Cli aria-setsize=\"-1\" class=\"OutlineElement Ltr SCXW112975816 BCX0\" data-aria-level=\"1\" data-aria-posinset=\"8\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"\",\"469777815\":\"hybridMultilevel\"}' data-listid=\"2\" role=\"listitem\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 0px 24px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; display: block; font-size: 11pt; font-family: Georgia, Georgia_MSFontService, serif; vertical-align: baseline;\"> \u003Cp aria-level=\"3\" class=\"Paragraph SCXW112975816 BCX0\" paraeid=\"{b85a8063-6929-425c-b0e5-8aa1695573e7}{146}\" paraid=\"1229339462\" role=\"heading\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: rgb(15, 71, 97); text-align: left; text-indent: 0px;\">\u003Cspan class=\"TextRun SCXW112975816 BCX0\" data-contrast=\"none\" lang=\"EN-US\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; color: rgb(0, 0, 0); font-size: 11pt; line-height: 17px; font-family: Georgia, Georgia_EmbeddedFont, Georgia_MSFontService, serif;\" xml:lang=\"EN-US\">\u003Cspan class=\"NormalTextRun SCXW112975816 BCX0\" data-ccp-parastyle=\"heading 3\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">Coordination of purely national labelling variations and preparation\u003C/span>\u003C/span>\u003Cspan class=\"EOP SCXW112975816 BCX0\" data-ccp-props='{\"134245418\":true,\"134245529\":true,\"201341983\":0,\"335559738\":160,\"335559739\":80,\"335559740\":240}' style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 11pt; line-height: 17px; font-family: Georgia, Georgia_EmbeddedFont, Georgia_MSFontService, serif; color: rgb(0, 0, 0);\">\u003C/span>\u003C/p> \u003C/li> \u003C/ul> \u003C/div> \u003Cdiv class=\"ListContainerWrapper SCXW112975816 BCX0\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative;\"> \u003Cul class=\"BulletListStyle1 SCXW112975816 BCX0\" role=\"list\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; list-style-type: disc; cursor: text; font-family: verdana; overflow: visible;\"> \u003Cli aria-setsize=\"-1\" class=\"OutlineElement Ltr SCXW112975816 BCX0\" data-aria-level=\"1\" data-aria-posinset=\"9\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"\",\"469777815\":\"hybridMultilevel\"}' data-listid=\"2\" role=\"listitem\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 0px 24px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; display: block; 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-webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">Updates and upload of product information texts to Veeva Vault\u003C/span>\u003C/span>\u003Cspan class=\"EOP SCXW112975816 BCX0\" data-ccp-props='{\"134245418\":true,\"134245529\":true,\"201341983\":0,\"335559738\":160,\"335559739\":80,\"335559740\":240}' style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 11pt; line-height: 17px; font-family: Georgia, Georgia_EmbeddedFont, Georgia_MSFontService, serif; color: rgb(0, 0, 0);\">\u003C/span>\u003C/p> \u003C/li> \u003C/ul> \u003C/div> \u003Cdiv class=\"ListContainerWrapper SCXW112975816 BCX0\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative;\"> \u003Cul class=\"BulletListStyle1 SCXW112975816 BCX0\" role=\"list\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; list-style-type: disc; cursor: text; font-family: verdana; overflow: visible;\"> \u003Cli aria-setsize=\"-1\" class=\"OutlineElement Ltr SCXW112975816 BCX0\" data-aria-level=\"1\" data-aria-posinset=\"10\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"\",\"469777815\":\"hybridMultilevel\"}' data-listid=\"2\" role=\"listitem\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 0px 24px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; display: block; font-size: 11pt; font-family: Georgia, Georgia_MSFontService, serif; vertical-align: baseline;\"> \u003Cp aria-level=\"3\" class=\"Paragraph SCXW112975816 BCX0\" paraeid=\"{b85a8063-6929-425c-b0e5-8aa1695573e7}{158}\" paraid=\"1346205207\" role=\"heading\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: rgb(15, 71, 97); text-align: left; text-indent: 0px;\">\u003Cspan class=\"TextRun SCXW112975816 BCX0\" data-contrast=\"none\" lang=\"EN-US\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-variant-ligatures: none !important; color: rgb(0, 0, 0); font-size: 11pt; line-height: 17px; font-family: Georgia, Georgia_EmbeddedFont, Georgia_MSFontService, serif;\" xml:lang=\"EN-US\">\u003Cspan class=\"NormalTextRun SCXW112975816 BCX0\" data-ccp-parastyle=\"heading 3\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text;\">Coordination of RA activities (dispatched dossier (download the dossiers from Veeva and coordinate with partner/stake holders) including QC of the dossiers & compliance with local regulations + all Veeva management activities\u003C/span>\u003C/span>\u003Cspan class=\"EOP SCXW112975816 BCX0\" data-ccp-props='{\"134245418\":true,\"134245529\":true,\"201341983\":0,\"335559738\":160,\"335559739\":80,\"335559740\":240}' style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; font-size: 11pt; line-height: 17px; font-family: Georgia, Georgia_EmbeddedFont, Georgia_MSFontService, serif; color: rgb(0, 0, 0);\">\u003C/span>\u003C/p> \u003C/li> \u003C/ul> \u003C/div> \u003Cdiv class=\"ListContainerWrapper SCXW112975816 BCX0\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; position: relative;\"> \u003Cul class=\"BulletListStyle1 SCXW112975816 BCX0\" role=\"list\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; list-style-type: disc; cursor: text; font-family: verdana; overflow: visible;\"> \u003Cli aria-setsize=\"-1\" class=\"OutlineElement Ltr SCXW112975816 BCX0\" data-aria-level=\"1\" data-aria-posinset=\"11\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"\",\"469777815\":\"hybridMultilevel\"}' data-listid=\"2\" role=\"listitem\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px 0px 0px 24px; padding: 0px; user-select: text; clear: both; cursor: text; overflow: visible; position: relative; direction: ltr; display: block; font-size: 11pt; font-family: Georgia, Georgia_MSFontService, serif; vertical-align: baseline;\"> \u003Cp aria-level=\"3\" class=\"Paragraph SCXW112975816 BCX0\" paraeid=\"{b85a8063-6929-425c-b0e5-8aa1695573e7}{164}\" paraid=\"1625832320\" role=\"heading\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; vertical-align: baseline; font-kerning: none; background-color: transparent; color: rgb(15, 71, 97); text-align: left; text-indent: 0px;\">\u003Cspan class=\"TextRun SCXW112975816 BCX0\" data-contrast=\"none\" lang=\"EN-US\" style=\"-webkit-user-drag: none; -webkit-tap-highlight-color: transparent; margin: 0px; padding: 0px; user-select: text; 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