{"id":55010,"date":"2021-02-08T11:16:48","date_gmt":"2021-02-08T11:16:48","guid":{"rendered":"https:\/\/joblistghana.com\/?p=55010"},"modified":"2021-02-08T11:16:48","modified_gmt":"2021-02-08T11:16:48","slug":"novartis-pharmaceuticals-recruitment-2021","status":"publish","type":"post","link":"https:\/\/joblistghana.com\/novartis-pharmaceuticals-recruitment-2021.html","title":{"rendered":"Novartis Pharmaceuticals Recruitment 2021"},"content":{"rendered":"<div class=\"ng-scope\">\n<p>\u00a0Support English West Africa (EWA) Regulatory Affairs (RA) Team with lifecycle maintenance activities in EWA Cluster as well as preparing submissions for post-approval changes in EWA Cluster.<\/p>\n<p><strong>Job Description<\/strong><\/p>\n<p><strong>Job Title: Regulatory Affairs Associate<\/strong><\/p>\n<p>\u2013 Follow up with Health Authorities to achieve conclusion of submitted applications and escalate where necessary.<br \/>\n\u2013 Maintain all necessary Novartis databases (e.g. DRAGON, NOVARIM) to ensure regulatory compliance at all times.<br \/>\n\u2013 Support RA Specialist by maintaining open communication with internal stakeholders such as NTO, CMC and the EWA RA Team as required and regularly provide feedback.<\/p>\n<p>Major Accountabilities of the position<br \/>\n\u2013 Prepare applications and ensure submissions for post-approval changes (variations) are made, and follow up with the Health Authority for timely approval.<br \/>\n\u2013 Maintain prompt submission of post approval commitments and other changes and timely responses to HA as required.<br \/>\n\u2013 Follow up with CMC and NTO for responses to deficiency letters received for submitted variations.<br \/>\n\u2013 Maintain adherence to Global and local\/regional processes with respect to life-cycle maintenance activities.<br \/>\n\u2013 Review the HA website regularly and ensure current information and updated guidelines are shared with the RA Team and relevant regulatory databases are up-to-date and accurate.<br \/>\n\u2013 Develop and maintain good working relationships with Health Authority, providing feedback from Health Authority regarding submissions made or any relevant changes (processes, guidelines, etc.)<br \/>\n\u2013 Ensure issues of non-compliance are handled with urgency and appropriate channels are engaged in a timely manner where necessary.<br \/>\n\u2013 Ensure compliance to local and global KPIs.<br \/>\n\u2013 Develop and maintain good working relationships with other Novartis functions\/departments both locally and globally as well with Health Authorities as required.<br \/>\n\u2013 Support RA projects as assigned by RA Manager and RA Specialist.<br \/>\n\u2013 Appropriately share any identified issues related to compliance and regulatory intelligence affecting lifecycle management.<\/p>\n<\/div>\n<div class=\"ng-scope\">\n<p class=\"question thick ng-scope ng-binding section2LeftfieldsInJobDetails jobDetailTextArea\">Minimum requirements<\/p>\n<p class=\"answer ng-scope section2LeftfieldsInJobDetails jobDetailTextArea\">Educational qualification<br \/>\nUniversity degree in Pharmacy or other Life Sciences<\/p>\n<p>Experience\/ Skills\/Competence<br \/>\n\u2013 1-2 years RA experience<br \/>\n\u2013 Good communication and negotiation skills<br \/>\n\u2013 Knowledge of CTD dossier format<br \/>\n\u2013 Detail-oriented and organized<br \/>\n\u2013 Good team player Good inter-personal skills<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u00a0Support English West Africa (EWA) Regulatory Affairs (RA) Team with lifecycle maintenance activities in EWA Cluster as well as preparing submissions for post-approval changes in EWA Cluster. Job Description Job&#8230;..<\/p>\n","protected":false},"author":6721,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_newsletter_tier_id":0,"footnotes":"","jetpack_publicize_message":"","jetpack_is_tweetstorm":false,"jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","enabled":false}}},"categories":[85],"tags":[],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p2nO32-ejg","_links":{"self":[{"href":"https:\/\/joblistghana.com\/wp-json\/wp\/v2\/posts\/55010"}],"collection":[{"href":"https:\/\/joblistghana.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/joblistghana.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/joblistghana.com\/wp-json\/wp\/v2\/users\/6721"}],"replies":[{"embeddable":true,"href":"https:\/\/joblistghana.com\/wp-json\/wp\/v2\/comments?post=55010"}],"version-history":[{"count":0,"href":"https:\/\/joblistghana.com\/wp-json\/wp\/v2\/posts\/55010\/revisions"}],"wp:attachment":[{"href":"https:\/\/joblistghana.com\/wp-json\/wp\/v2\/media?parent=55010"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/joblistghana.com\/wp-json\/wp\/v2\/categories?post=55010"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/joblistghana.com\/wp-json\/wp\/v2\/tags?post=55010"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}