{"id":7663,"date":"2024-05-12T19:38:46","date_gmt":"2024-05-12T14:08:46","guid":{"rendered":"https:\/\/pharmaceuticalcarrier.com\/?post_type=job_listing&#038;p=7663"},"modified":"2024-05-12T19:38:49","modified_gmt":"2024-05-12T14:08:49","slug":"opportunity-for-regulatory-affairs-executive-at-advanz-pharma-apply-before-30th-may-2024","status":"publish","type":"job_listing","link":"https:\/\/pharmaceuticalcarrier.com\/index.php\/job\/opportunity-for-regulatory-affairs-executive-at-advanz-pharma-apply-before-30th-may-2024\/","title":{"rendered":"Opportunity for Regulatory Affairs Executive at ADVANZ PHARMA-Apply before 30th May 2024"},"content":{"rendered":"<h2>About Advanz Pharma<\/h2>\n<p>Advanz Pharma has a comprehensive approach to addressing various medical needs across different therapeutic areas. Their focus on specialty, hospital, and rare disease medicines indicates a commitment to serving patient populations with unique and often complex healthcare requirements. By offering a diverse portfolio of innovative medicines, specialty generics, biosimilars, and originator brands, we aim to cater to a wide range of medical conditions.<\/p><div class=\"pharm-content\" id=\"pharm-3210522947\"><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<p>Our coverage of therapeutic areas such as hepatology, gastroenterology, anti-infectives, critical care, endocrinology, central nervous system disorders, and rare diseases suggests a broad spectrum of medical solutions. This approach reflects a dedication to advancing healthcare and improving patient outcomes across multiple fronts.<\/p>\n<div class=\"flex-1 overflow-hidden\">\n<div class=\"react-scroll-to-bottom--css-wfnpq-79elbk h-full\">\n<div class=\"react-scroll-to-bottom--css-wfnpq-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-7\" 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=\"cf640770-b47b-45fc-917a-bc2580d1f9d5\">\n<div class=\"markdown prose w-full break-words dark:prose-invert dark\">\n<h2><strong>Post: Executive &#8211; Regulatory Affairs UK\/IE<\/strong><\/h2>\n<h3><strong>Job Description<\/strong><\/h3>\n<p>As ADVANZ PHARMA solidifies its position as the preferred partner for specialty, hospital, and rare disease medicines, we present an exciting opportunity for an Executive in Regulatory Affairs.<\/p>\n<ul>\n<li><strong>Renewals and Maintenance<\/strong>: Responsible for planning and preparing for renewals and annual maintenance of Marketing Authorizations (MA&#8217;s), ensuring compliance with regulatory requirements and uninterrupted product supply.<\/li>\n<li><strong>Change Management<\/strong>: Assess change requests to determine regulatory strategy and required documents for submissions, ensuring timely communication with stakeholders.<\/li>\n<li><strong>Approval Process<\/strong>: Oversee approval processes, promptly responding to requests for information and carrying out post-approval activities as per regulatory procedures.<\/li>\n<li><strong>Regulatory Obligations<\/strong>: Meet other regulatory obligations such as submissions of Article 61 (3) updates, MAH Transfers, PSUR, and Sunset clause applications.<\/li>\n<li><strong>Compliance and Training<\/strong>: Ensure adherence to departmental procedures, maintain up-to-date training records, and regulatory databases.<\/li>\n<li><strong>Continuous Improvement<\/strong>: Actively participate in continuous improvement initiatives and implementation.<\/li>\n<li><strong>Process Ownership<\/strong>: Act as process owners for specific regulatory procedures as delegated.<\/li>\n<li><strong>Inspection Readiness<\/strong>: Support line managers in preparing for health authority inspections.<\/li>\n<li><strong>Deviation and CAPAs<\/strong>: Ensure timely completion of assigned deviations and Corrective and Preventive Actions.<\/li>\n<li><strong>Entrepreneurial Spirit<\/strong>: Thrive in an entrepreneurial environment and take accountability for results.<\/li>\n<li><strong>Embrace Challenge and Change<\/strong>: Adopt a growth mindset approach towards challenges and changes.<\/li>\n<li><strong>Bias for Action<\/strong>: Demonstrate a bias for action and fast decision-making.<\/li>\n<li><strong>Company Values<\/strong>: Consistently embody company core values: Entrepreneurship, Speed, and Integrity.<\/li>\n<li><strong>Team Collaboration<\/strong>: Foster collaboration across all business functions with open, honest, and respectful cooperation.<\/li>\n<li><strong>Contribute to Workplace Culture<\/strong>: Contribute to making ADVANZ PHARMA a desired place to work.<\/li>\n<\/ul>\n<h2><strong>Candidate Profile<\/strong><\/h2>\n<ul>\n<li><strong>Regulatory Training<\/strong>: Formal training in Regulatory Affairs.<\/li>\n<li><strong>Educational Background<\/strong>: Graduate\/Post-Graduate in a science discipline, preferably life science\/pharmacy.<\/li>\n<li><strong>Experience<\/strong>: Significant experience in life cycle management of pharmaceuticals in UK\/IE\/EU markets.<\/li>\n<li><strong>CTD and Module 1 Expertise<\/strong>: Proficient in CTD and Module 1 writing, review, and submission.<\/li>\n<li><strong>Safety Variation Submissions<\/strong>: Experience in safety variation submissions, including writing\/review and handling RFIs.<\/li>\n<li><strong>Regulatory Guidelines<\/strong>: Good understanding of ICH and regional regulatory guidelines, with the ability to interpret and apply them independently.<\/li>\n<li><strong>Project Management and Communication<\/strong>: Proficient in project management and possess strong communication skills.<\/li>\n<li><strong>Personal Attributes<\/strong>: Pleasant personality with a collaborative approach, interpersonal skills, and a high level of team spirit.<\/li>\n<li><strong>Drive and Decision-Making<\/strong>: Demonstrate drive, urgency, and solution-oriented decision-making.<\/li>\n<li><strong>Values Alignment<\/strong>: Inspired by the company values of entrepreneurship, speed, and integrity.<\/li>\n<li><strong>Learning Agility<\/strong>: Display learning agility and scalability, with a desire for continuous improvement and development.<\/li>\n<li><strong>Work Environment Compatibility<\/strong>: Ability to thrive in a growing, unique, and inclusive work environment.<\/li>\n<\/ul>\n<h2><strong>Additional Information<\/strong><\/h2>\n<ul>\n<li><strong>Qualification<\/strong>: M.Pharm, B.Pharm, M.Sc<\/li>\n<li><strong>Location<\/strong>: Mumbai<\/li>\n<li><strong>Industry Type<\/strong>: Pharma\/Healthcare\/Clinical Research<\/li>\n<li><strong>Functional Area<\/strong>: Regulatory Affairs<\/li>\n<li><strong>End Date<\/strong>: 30th May 2024<\/li>\n<\/ul>\n<p>Please feel free to reach out with any questions or to apply for this exciting opportunity. We look forward to welcoming you to the ADVANZ PHARMA team!<\/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\/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>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"author":1,"featured_media":7666,"template":"","meta":{"_uag_custom_page_level_css":"","_promoted":"","_job_location":"Mumbai Maharashtra","_application":"https:\/\/careers.advanzpharma.com\/job\/Andheri-%28East%29-Executive-Regulatory-Affairs-UKIE-Mumbai-400\/1051283266\/","_company_name":"Advanz Pharma","_company_website":"https:\/\/www.advanzpharma.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-7663","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\/05\/ADVANZ-PHARMA.jpg",1600,900,false],"thumbnail":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/05\/ADVANZ-PHARMA-150x150.jpg",150,150,true],"medium":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/05\/ADVANZ-PHARMA-300x169.jpg",300,169,true],"medium_large":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/05\/ADVANZ-PHARMA-768x432.jpg",640,360,true],"large":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/05\/ADVANZ-PHARMA-1024x576.jpg",640,360,true],"1536x1536":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/05\/ADVANZ-PHARMA-1536x864.jpg",1536,864,true],"2048x2048":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/05\/ADVANZ-PHARMA.jpg",1600,900,false],"authorship-box-avatar":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/05\/ADVANZ-PHARMA-150x150.jpg",150,150,true],"authorship-box-related":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/05\/ADVANZ-PHARMA-70x70.jpg",70,70,true],"sow-carousel-default":["https:\/\/pharmaceuticalcarrier.com\/wp-content\/uploads\/2024\/05\/ADVANZ-PHARMA.jpg",272,153,false]},"uagb_author_info":{"display_name":"Pharmacareer","author_link":"https:\/\/pharmaceuticalcarrier.com\/index.php\/author\/grandirpharmagmail-com\/"},"uagb_comment_info":0,"uagb_excerpt":"About Advanz Pharma Advanz Pharma has a comprehensive approach to addressing various medical needs across different therapeutic areas. Their focus on specialty, hospital, and rare disease medicines indicates a commitment to serving patient populations with unique and often complex healthcare Read More","_links":{"self":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/job-listings\/7663","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\/7666"}],"wp:attachment":[{"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/media?parent=7663"}],"wp:term":[{"taxonomy":"job_listing_category","embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/job-categories?post=7663"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/pharmaceuticalcarrier.com\/index.php\/wp-json\/wp\/v2\/job-types?post=7663"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}