{"id":7696,"date":"2024-05-12T19:40:43","date_gmt":"2024-05-12T14:10:43","guid":{"rendered":"https:\/\/pharmaceuticalcarrier.com\/?post_type=job_listing&#038;p=7696"},"modified":"2024-05-12T19:40:46","modified_gmt":"2024-05-12T14:10:46","slug":"regulatory-affairs-specialist-require-at-medicines-patent-pool-apply-before-30th-may-2024","status":"publish","type":"job_listing","link":"https:\/\/pharmaceuticalcarrier.com\/index.php\/job\/regulatory-affairs-specialist-require-at-medicines-patent-pool-apply-before-30th-may-2024\/","title":{"rendered":"Regulatory Affairs Specialist Require at Medicines Patent Pool-Apply before 30th May 2024"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-transparent ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/job\/regulatory-affairs-specialist-require-at-medicines-patent-pool-apply-before-30th-may-2024\/#About_Medicines_Patent_Pool\" >About Medicines Patent Pool<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/job\/regulatory-affairs-specialist-require-at-medicines-patent-pool-apply-before-30th-may-2024\/#Regulatory_Affairs_Specialist\" >Regulatory Affairs Specialist<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/job\/regulatory-affairs-specialist-require-at-medicines-patent-pool-apply-before-30th-may-2024\/#About_the_Role\" >About the Role<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/job\/regulatory-affairs-specialist-require-at-medicines-patent-pool-apply-before-30th-may-2024\/#Job_Description\" >Job Description<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/job\/regulatory-affairs-specialist-require-at-medicines-patent-pool-apply-before-30th-may-2024\/#Candidate_Profile\" >Candidate Profile<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/job\/regulatory-affairs-specialist-require-at-medicines-patent-pool-apply-before-30th-may-2024\/#Personal_Qualities\" >Personal Qualities<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/job\/regulatory-affairs-specialist-require-at-medicines-patent-pool-apply-before-30th-may-2024\/#Additional_Information\" >Additional Information<\/a><\/li><\/ul><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"About_Medicines_Patent_Pool\"><\/span>About <span style=\"font-size: revert; color: initial;\">Medicines Patent Pool<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-size: revert; color: initial;\">The Medicines Patent Pool (MPP) indeed plays a crucial role in global public health by fostering access to essential medicines in low- and middle-income countries (LMICs). By collaborating with various stakeholders, including governments, industry, and civil society, the MPP helps address the challenge of affordability and availability of life-saving medications in regions where they are most needed. Through its unique approach of pooling intellectual property and licensing agreements, the MPP facilitates generic manufacturing and encourages the development of new formulations, ultimately contributing to improved healthcare outcomes worldwide.<\/span><\/p><div class=\"pharm-content\" id=\"pharm-1494392710\"><script async src=\"\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-8402705006112223\" crossorigin=\"anonymous\"><\/script><ins class=\"adsbygoogle\" style=\"display:block;\" data-ad-client=\"ca-pub-8402705006112223\" \ndata-ad-slot=\"7652789694\" \ndata-ad-format=\"auto\"><\/ins>\n<script> \n(adsbygoogle = window.adsbygoogle || []).push({}); \n<\/script>\n<\/div>\n<div class=\"flex-1 overflow-hidden\">\n<div class=\"react-scroll-to-bottom--css-fgxuy-79elbk h-full\">\n<div class=\"react-scroll-to-bottom--css-fgxuy-1n7m0yu\">\n<div>\n<div class=\"flex flex-col text-sm pb-9\">\n<div class=\"w-full text-token-text-primary\" dir=\"auto\" data-testid=\"conversation-turn-5\" data-scroll-anchor=\"true\">\n<div class=\"py-2 px-3 text-base md:px-4 m-auto md:px-5 lg:px-1 xl:px-5\">\n<div class=\"mx-auto flex flex-1 gap-3 text-base juice:gap-4 juice:md:gap-6 md:max-w-3xl lg:max-w-[40rem] xl:max-w-[48rem]\">\n<div class=\"relative flex w-full min-w-0 flex-col agent-turn\">\n<div class=\"flex-col gap-1 md:gap-3\">\n<div class=\"flex flex-grow flex-col max-w-full\">\n<div class=\"min-h-[20px] text-message flex flex-col items-start whitespace-pre-wrap break-words [.text-message+&amp;]:mt-5 overflow-x-auto gap-3\" dir=\"auto\" data-message-author-role=\"assistant\" data-message-id=\"be2143cb-fc16-48a9-be8b-c63622f68ac7\">\n<div class=\"markdown prose w-full break-words dark:prose-invert dark\">\n<h3><span class=\"ez-toc-section\" id=\"Regulatory_Affairs_Specialist\"><\/span>Regulatory Affairs Specialist<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<h4><span class=\"ez-toc-section\" id=\"About_the_Role\"><\/span>About the Role<span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p>The Regulatory Affairs Specialist, reporting to the Head of Alliance and India Office, will play a pivotal role in providing regulatory expertise to Medicines Patent Pool (MPP) licensing activities. They will guide the MPP team and partners on global regulatory processes and lead the development and enhancement of the MPP regulatory database for healthcare products across Low- and Middle-Income Countries (LMICs).<\/p>\n<h4><span class=\"ez-toc-section\" id=\"Job_Description\"><\/span>Job Description<span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p><strong>Regulatory Activities:<\/strong><\/p>\n<ul>\n<li>Take ownership of the Regulatory Database development initiative, focusing on regulatory requirements for various product categories in LMICs.<\/li>\n<li>Collect, interpret, and verify raw data for the Regulatory Database, managing the project lifecycle until successful launch.<\/li>\n<li>Analyze and track regulatory landscape changes across LMICs for specified product categories, ensuring ongoing database maintenance.<\/li>\n<li>Stay updated on guideline changes from ICH, FDA, WHO-PQ, EMA, and other regulatory authorities.<\/li>\n<li>Engage with regulators to identify regulatory pathways for MPP licensees.<\/li>\n<\/ul>\n<p><strong>In Licensing:<\/strong><\/p>\n<ul>\n<li>Provide regulatory guidance to facilitate identification and prioritization of suitable in-licensing candidates.<\/li>\n<li>Conduct regulatory assessments of selected products for in-licensing.<\/li>\n<li>Contribute to feasibility studies and develop business cases for in-licensing.<\/li>\n<li>Provide regulatory inputs during license negotiations and agreement finalization.<\/li>\n<\/ul>\n<p><strong>Out Licensing:<\/strong><\/p>\n<ul>\n<li>Participate in Expression of Interest process and selection of out licensing beneficiaries.<\/li>\n<li>Monitor development activities and regulatory filings by MPP sublicensees.<\/li>\n<li>Maintain communication with sublicensees and identify areas for regulatory support to accelerate processes.<\/li>\n<li>Support Alliance Management team in fostering effective partnerships.<\/li>\n<\/ul>\n<p><strong>Other Responsibilities:<\/strong><\/p>\n<ul>\n<li>Provide regulatory inputs to case studies within MPP.<\/li>\n<li>Collaborate with legal, policy, market access, technology transfer, and communications teams, offering regulatory insights.<\/li>\n<li>Perform other duties as assigned.<\/li>\n<\/ul>\n<h4><span class=\"ez-toc-section\" id=\"Candidate_Profile\"><\/span>Candidate Profile<span class=\"ez-toc-section-end\"><\/span><\/h4>\n<ul>\n<li>University degree in Pharmacy or related discipline with strong regulatory background.<\/li>\n<li>10+ years of regulatory affairs experience in pharmaceutical industry.<\/li>\n<li>Solid understanding of generic drug registration process, particularly in emergent markets.<\/li>\n<li>Ability to manage multiple projects effectively.<\/li>\n<li>Proficiency in regulatory guidelines from major authorities.<\/li>\n<li>Native-level fluency in English.<\/li>\n<li>Experience in handling registrations of different product categories and dosage forms.<\/li>\n<li>Knowledge of intellectual property and voluntary licensing.<\/li>\n<li>Interest in public health and access to medicines in low-resource settings.<\/li>\n<li>Understanding of general NCE registration process.<\/li>\n<\/ul>\n<h4><span class=\"ez-toc-section\" id=\"Personal_Qualities\"><\/span>Personal Qualities<span class=\"ez-toc-section-end\"><\/span><\/h4>\n<ul>\n<li>Autonomous, self-motivated, and able to work independently or collaboratively.<\/li>\n<li>Strategic and analytical thinker with problem-solving skills.<\/li>\n<li>Ownership attitude with excellent organizational abilities and flexibility.<\/li>\n<li>Adaptable to diverse work styles and cultures.<\/li>\n<li>Strong relationship-building skills, able to gain trust and foster successful negotiations.<\/li>\n<\/ul>\n<h4><span class=\"ez-toc-section\" id=\"Additional_Information\"><\/span>Additional Information<span class=\"ez-toc-section-end\"><\/span><\/h4>\n<ul>\n<li>Qualification: University degree in Pharmacy<\/li>\n<li>Experience: 10+ years<\/li>\n<li>Location: Mumbai, India<\/li>\n<li>Industry Type: Pharma\/ Healthcare\/ Clinical research<\/li>\n<li>Functional Area: Regulatory Affairs<\/li>\n<li>End Date: 30th May 2024<\/li>\n<li>For more articles,\u00a0<strong><a href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/ayurveda\/\">Kindly Click<\/a>\u00a0here<\/strong>.<\/li>\n<li>For pharmaceutical\u00a0<a title=\"jobs\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/jobs\/\">jobs<\/a>, follow us on<strong>\u00a0<a href=\"https:\/\/www.linkedin.com\/company\/pharmaceuticalcarrier\/?viewAsMember=true\" target=\"_blank\" rel=\"noopener\">LinkedIn<\/a><\/strong>\n<div class=\"job_description\">\n<p><strong>For more jobs, kindly visit our job section.<\/strong><\/p>\n<p><a href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/jobs\/\">www.pharmaceuticalcarrier.com\/Jobs<\/a><\/p>\n<\/div>\n<\/li>\n<li>\n<div class=\"job_description\">\n<div id=\"pharm-1851754010\" class=\"pharm-content pharm-highlight-wrapper\" data-title=\"Placement name: content; Ads: Ad created on September 6, 2022 12:53 pm\">\n<div class=\"flex-1 overflow-hidden\">\n<div class=\"react-scroll-to-bottom--css-illqk-79elbk h-full\">\n<div class=\"react-scroll-to-bottom--css-illqk-1n7m0yu\">\n<div>\n<div class=\"flex flex-col text-sm pb-9\">\n<div class=\"w-full text-token-text-primary\" dir=\"auto\" data-testid=\"conversation-turn-5\" data-scroll-anchor=\"true\">\n<div class=\"py-2 px-3 text-base md:px-4 m-auto md:px-5 lg:px-1 xl:px-5\">\n<div class=\"mx-auto flex flex-1 gap-3 text-base juice:gap-4 juice:md:gap-6 md:max-w-3xl lg:max-w-[40rem] xl:max-w-[48rem]\">\n<div class=\"relative flex w-full min-w-0 flex-col agent-turn\">\n<div class=\"flex-col gap-1 md:gap-3\">\n<div class=\"flex flex-grow flex-col max-w-full\">\n<div class=\"min-h-[20px] text-message flex flex-col items-start whitespace-pre-wrap break-words [.text-message+&amp;]:mt-5 overflow-x-auto gap-3\" dir=\"auto\" 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Medicines Patent Pool The Medicines Patent Pool (MPP) indeed plays a crucial role in global public health by fostering access to essential medicines in low- and middle-income countries (LMICs). By collaborating with various stakeholders, including governments, industry, and civil Read More","_links":{"self":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/job-listings\/7696","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/types\/job_listing"}],"author":[{"embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/media\/7697"}],"wp:attachment":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/media?parent=7696"}],"wp:term":[{"taxonomy":"job_listing_category","embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/job-categories?post=7696"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/job-types?post=7696"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}