{"id":8101,"date":"2024-08-12T08:48:25","date_gmt":"2024-08-12T03:18:25","guid":{"rendered":"https:\/\/pharmaceuticalcarrier.com\/?post_type=job_listing&#038;p=8101"},"modified":"2024-08-12T08:48:28","modified_gmt":"2024-08-12T03:18:28","slug":"opportunity-to-work-as-reg-cmc-associate-at-pfizer-apply-before-30th-august-2024","status":"publish","type":"job_listing","link":"https:\/\/pharmaceuticalcarrier.com\/index.php\/job\/opportunity-to-work-as-reg-cmc-associate-at-pfizer-apply-before-30th-august-2024\/","title":{"rendered":"Opportunity to work as Reg CMC Associate at Pfizer- Apply before 30th August 2024"},"content":{"rendered":"<div class=\"react-scroll-to-bottom--css-hizes-1n7m0yu\">\n<div class=\"flex flex-col text-sm md:pb-9\">\n<div class=\"w-full text-token-text-primary sm:AIPRM__conversation__response\" dir=\"auto\" data-testid=\"conversation-turn-3\" data-scroll-anchor=\"true\">\n<div class=\"text-base py-[18px] px-3 md:px-4 m-auto md:px-5 lg:px-1 xl:px-5\">\n<div class=\"mx-auto flex flex-1 gap-4 text-base md:gap-5 lg:gap-6 md:max-w-3xl lg:max-w-[40rem] xl:max-w-[48rem]\">\n<div class=\"group\/conversation-turn 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 AIPRM__conversation__response\">\n<div class=\"min-h-[20px] text-message flex w-full flex-col items-end gap-2 whitespace-pre-wrap break-words [.text-message+&amp;]:mt-5 overflow-x-auto\" dir=\"auto\" data-message-author-role=\"assistant\" data-message-id=\"b101688d-639f-454a-a9f4-7534cfc51e48\">\n<div class=\"flex w-full flex-col gap-1 empty:hidden first:pt-[3px]\">\n<div class=\"markdown prose w-full break-words dark:prose-invert dark\">\n<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-3'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/job\/opportunity-to-work-as-reg-cmc-associate-at-pfizer-apply-before-30th-august-2024\/#Job_Title_Associate-I_Regulatory_CMC\" >Job Title: Associate-I Regulatory CMC<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/job\/opportunity-to-work-as-reg-cmc-associate-at-pfizer-apply-before-30th-august-2024\/#Join_Pfizer_the_Global_Leader_in_Biopharmaceutical_Innovation\" >Join Pfizer, the Global Leader in Biopharmaceutical Innovation<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/job\/opportunity-to-work-as-reg-cmc-associate-at-pfizer-apply-before-30th-august-2024\/#Job_Summary\" >Job Summary<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/job\/opportunity-to-work-as-reg-cmc-associate-at-pfizer-apply-before-30th-august-2024\/#Key_Responsibilities\" >Key Responsibilities<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/job\/opportunity-to-work-as-reg-cmc-associate-at-pfizer-apply-before-30th-august-2024\/#Candidate_Profile\" >Candidate Profile<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/job\/opportunity-to-work-as-reg-cmc-associate-at-pfizer-apply-before-30th-august-2024\/#Additional_Information\" >Additional Information<\/a><\/li><\/ul><\/nav><\/div>\n<h3><span class=\"ez-toc-section\" id=\"Job_Title_Associate-I_Regulatory_CMC\"><\/span>Job Title: Associate-I Regulatory CMC<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<h4><\/h4>\n<h4><span class=\"ez-toc-section\" id=\"Join_Pfizer_the_Global_Leader_in_Biopharmaceutical_Innovation\"><\/span><strong>Join Pfizer, the Global Leader in Biopharmaceutical Innovation<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p>At Pfizer, we are committed to transforming healthcare through groundbreaking approaches that enhance the health and well-being of both people and animals. As a premier biopharmaceutical company, we discover, develop, manufacture, and deliver safe, effective, and high-quality prescription medicines. Our collaborative efforts with healthcare providers, governments, and local communities worldwide enable us to expand access to our medicines and improve healthcare quality and systems support.<\/p><div class=\"pharm-content\" id=\"pharm-4144432366\"><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<hr \/>\n<h3><span class=\"ez-toc-section\" id=\"Job_Summary\"><\/span><strong>Job Summary<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>As an Associate-I Regulatory CMC, you will play a critical role in Global Regulatory Sciences (GRS-CMC) by assisting Global Regulatory Leads (GRLs) in defining global regulatory submission strategies. Your contributions will ensure timely and high-quality regulatory submissions related to post-approval changes, original applications, global expansion, and license maintenance for new and on-market biosimilar, biologic, and small molecule products. You will also support manufacturing plants and manage compliance issues.<\/p>\n<hr \/>\n<h3><span class=\"ez-toc-section\" id=\"Key_Responsibilities\"><\/span><strong>Key Responsibilities<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li><\/li>\n<li><strong>Regulatory Support<\/strong>: Provide regulatory expertise for biosimilars, biologics, and small molecule development projects, collaborating with project leads, cross-functional teams, local and regional regulatory colleagues, external partners, and global health authorities.<\/li>\n<li><strong>Dossier Management<\/strong>: Prepare and maintain core dossiers for original applications and subsequent changes, ensuring compliance with moderate technical and regulatory complexity. Coordinate quality query responses to deficiency letters from health authorities.<\/li>\n<li><strong>Strategy &amp; Submission<\/strong>: Independently drive global regulatory strategies for post-approval changes and global expansion submissions. Author quality and timely CMC contributions for license maintenance activities, including US Annual Reports, Renewals, APRR, YBPR, and more.<\/li>\n<li><strong>Regulatory Guidance<\/strong>: Provide regulatory advice on biologics, biosimilars, and small molecule programs, negotiating submission data requirements and influencing cross-functional teams to meet deliverable dates.<\/li>\n<li><strong>Regulatory Compliance<\/strong>: Ensure compliance with global regulatory standards, procedures, and policies. Suggest and implement system improvements to enhance regulatory compliance, reduce cycle time, and increase efficiency.<\/li>\n<li><strong>Mentorship<\/strong>: Guide and mentor new team members on the technical aspects of regulatory requirements and Pfizer\u2019s systems and tools.<\/li>\n<\/ul>\n<hr \/>\n<h3><span class=\"ez-toc-section\" id=\"Candidate_Profile\"><\/span><strong>Candidate Profile<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li><\/li>\n<li><strong>Educational Background<\/strong>: Bachelor\u2019s or Master\u2019s degree in Biotechnology, Pharmacy, or Science, or a Ph.D. in Biotechnology\/Biological Sciences.<\/li>\n<li><strong>Experience<\/strong>: 3-5 years of experience in the pharmaceutical industry, particularly in regulatory sciences, with a focus on global submissions and life-cycle management. Experience with sterile injectable submissions is a plus.<\/li>\n<li><strong>Skills<\/strong>: Strong communication skills, problem-solving abilities, and a proactive, results-oriented approach. Knowledge of global regulatory requirements, ICH guidelines, and the pharmaceutical industry is essential.<\/li>\n<li><strong>Additional Knowledge<\/strong>: Understanding of CMC regulatory policies and the ability to interpret and apply these in assigned projects.<\/li>\n<\/ul>\n<hr \/>\n<h3><span class=\"ez-toc-section\" id=\"Additional_Information\"><\/span><strong>Additional Information<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li><strong>Experience<\/strong>: 3-5 Years<\/li>\n<li><strong>Qualification<\/strong>: M.Pharm, B.Pharm, M.Sc, or Ph.D.<\/li>\n<li><strong>Location<\/strong>: Chennai<\/li>\n<li><strong>Industry Type<\/strong>: Pharma \/ Healthcare \/ Clinical Research<\/li>\n<li><strong>Application Deadline<\/strong>: 30th August 2024<\/li>\n<\/ul>\n<p>Join Pfizer and contribute to shaping the future of healthcare. Apply today!<\/p>\n<ul>\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\u00a0<a title=\"jobs\" href=\"https:\/\/pharmaceuticalcarrier.com\/index.php\/jobs\/\">jobs<\/a>, 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<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"mt-1 flex gap-3 empty:hidden -ml-2\">\n<div class=\"items-center justify-start rounded-xl p-1 flex\">\n<div class=\"flex items-center\"><button class=\"rounded-lg text-token-text-secondary hover:bg-token-main-surface-secondary\"><\/button><button class=\"rounded-lg text-token-text-secondary hover:bg-token-main-surface-secondary\"><br \/>\n<\/button><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"author":1,"featured_media":7402,"template":"","meta":{"_uag_custom_page_level_css":"","_promoted":"","_job_location":"Chennai","_application":"https:\/\/pfizer.wd1.myworkdayjobs.com\/en-US\/PfizerCareers\/job\/India---Chennai\/Associate--I-Reg-CMC_4916897","_company_name":"Pfizer","_company_website":"https:\/\/www.pfizer.com\/","_company_tagline":"","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job-categories":[614],"job-types":[17],"class_list":{"0":"post-8101","1":"job_listing","2":"type-job_listing","3":"status-publish","4":"has-post-thumbnail","5":"hentry","7":"job-type-full-time"},"uagb_featured_image_src":{"full":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/03\/Pfizer-1.jpg",1600,900,false],"thumbnail":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/03\/Pfizer-1-150x150.jpg",150,150,true],"medium":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/03\/Pfizer-1-300x169.jpg",300,169,true],"medium_large":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/03\/Pfizer-1-768x432.jpg",640,360,true],"large":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/03\/Pfizer-1-1024x576.jpg",640,360,true],"1536x1536":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/03\/Pfizer-1-1536x864.jpg",1536,864,true],"2048x2048":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/03\/Pfizer-1.jpg",1600,900,false],"authorship-box-avatar":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/03\/Pfizer-1-150x150.jpg",150,150,true],"authorship-box-related":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/03\/Pfizer-1-70x70.jpg",70,70,true],"sow-carousel-default":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/03\/Pfizer-1-272x182.jpg",272,182,true]},"uagb_author_info":{"display_name":"Pharmacareer","author_link":"https:\/\/pharmaceuticalcarrier.com\/index.php\/author\/grandirpharmagmail-com\/"},"uagb_comment_info":0,"uagb_excerpt":"Job Title: Associate-I Regulatory CMC Join Pfizer, the Global Leader in Biopharmaceutical Innovation At Pfizer, we are committed to transforming healthcare through groundbreaking approaches that enhance the health and well-being of both people and animals. As a premier biopharmaceutical company, Read More","_links":{"self":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/job-listings\/8101","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\/7402"}],"wp:attachment":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/media?parent=8101"}],"wp:term":[{"taxonomy":"job_listing_category","embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/job-categories?post=8101"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/job-types?post=8101"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}