{"id":14621,"date":"2024-05-22T04:41:26","date_gmt":"2024-05-22T04:41:26","guid":{"rendered":"https:\/\/exam4sure.com\/jobs\/?p=14621"},"modified":"2024-05-22T04:41:26","modified_gmt":"2024-05-22T04:41:26","slug":"assistant-manager-regulatory","status":"publish","type":"post","link":"https:\/\/exam4sure.com\/jobs\/assistant-manager-regulatory\/","title":{"rendered":"Assistant Manager- Regulatory"},"content":{"rendered":"<h6>DESCRIPTION<\/h6>\n<h5><a href=\"https:\/\/joblagii.com\/company\/johnson-johnson\">Assistant Manager- Regulatory<\/a><\/h5>\n<p>The Associate Regulatory Affairs Manager has the responsibility to Support regulatory department to ensure efficient and compliant business processes and environment.<\/p>\n<p>Assists in the registration of new products\/changes\/renewal licenses by preparing documentation needed for registration submissions in India, Sri Lanka and Bangladesh.<\/p>\n<p>The Associate Regulatory Affairs Manager will independently, with minimum supervision, initiate and prepare the regulatory submissions, interact with Business Units Regulatory affairs teams, interact with regulatory agencies\/health authorities to obtain and maintain product approvals with a focus on India, Sri Lanka and Bangladesh as needed and be able to interact and work as a strategic partner with cross functional team members on regulatory solutions.<\/p>\n<h5><a href=\"https:\/\/joblagii.com\/company\/johnson-johnson\">Assistant Manager- Regulatory<\/a><\/h5>\n<p>Combines knowledge of scientific, regulatory and business issues to enable JJV products to meet required legislation. Has department\/site level influence and is generally recognized as an expert resource within the department. Identifies emerging regulatory issues and analyses broad scope implications of changing regulations and guidance.<\/p>\n<p>Identifies data needed, obtains these data and ensures that they are effectively presented for the registration of products in the region. Utilizes technical regulatory skills to propose strategies on complex issues.<\/p>\n<p>Adheres to environmental policy, procedures, and supports department environmental objectives.<\/p>\n<h5><a href=\"https:\/\/joblagii.com\/company\/johnson-johnson\">Assistant Manager- Regulatory<\/a><\/h5>\n<ul>\n<li>Determine and communicate submission and approval requirements.<\/li>\n<li>Participate in new product development teams to provide input and expertise on regulatory requirements, determination of global regulatory strategies, review and approval of documentation to support regulatory submissions worldwide.<\/li>\n<li>Assess the acceptability of documentation for submission filing to comply with regulatory requirements for clinical trials, marketing applications and corporate goals, to secure submission approval.<\/li>\n<li>Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies and complete all regulatory projects as assigned<\/li>\n<li>Proactive in providing strategies\/creative ideas for improvements and fast regulatory processes\n<ul>\n<li>Prepare labelling and ensure all labelling activities are accordance to the internal SOP.<\/li>\n<li>Participate in all intercompany audits<\/li>\n<li>Participate in all monthly &amp; quarterly meetings\/review<\/li>\n<li>Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.<\/li>\n<li>Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization.<\/li>\n<li>Collaborate with cross-functional teams including R&amp;D, Quality Assurance, and Legal to ensure that all regulatory requirements are met throughout the product lifecycle.<\/li>\n<li>Prepare and submit regulatory submissions, including but not limited to, product registrations, pre-market notifications, and post-market surveillance reports.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h5><a href=\"https:\/\/joblagii.com\/company\/johnson-johnson\">Assistant Manager- Regulatory<\/a><\/h5>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>Liaise with regulatory authorities and act as the primary point of contact during inspections, audits, and regulatory agency interactions.<br \/>\nConduct risk assessments and develop mitigation strategies to manage regulatory risks.<\/li>\n<li>Review and approve product labelling, promotional materials, and other relevant documentation to ensure compliance with regulatory requirements.<\/li>\n<li>Provide regulatory guidance and support to internal stakeholders, including product development teams, to ensure that regulatory requirements are incorporated into the development process.<\/li>\n<li>Monitor and track regulatory compliance metrics and provide regular reports to senior management.<\/li>\n<li>Maintain a thorough understanding of international regulations in relevant markets and guide the organization regarding international expansion plans.<\/li>\n<li>Able to manage the team of 3-4 individuals<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h6>QUALIFICATIONS<\/h6>\n<h5><a href=\"https:\/\/joblagii.com\/company\/johnson-johnson\">Assistant Manager- Regulatory<\/a><\/h5>\n<ul>\n<li>Bachelor of Science Degree with 5-7 years of experience<\/li>\n<li>Strong communication, organizational, negotiation and interpersonal skills.<\/li>\n<li>Expert knowledge, understanding and application of principles concepts and practices of government regulations.<\/li>\n<li>Ability to organize and analyze technical data and identify issues or gaps.<\/li>\n<li>Foundational regulatory knowledge to maintain legal status of products and minimize risk.<\/li>\n<li>Broad based technical knowledge and skills in diverse areas of business (e.g., R&amp;D, Operations, QA, Laboratories, Marketing, etc.) and ability to effectively negotiate and influence affiliates and Regulatory agencies are a plus. Self- motivated and committed to a team approach.<\/li>\n<\/ul>\n<div class=\"job-title-location fs-12 fs-m-6 fs-l-4\">\n<div class=\"job-title-location fs-12 fs-m-6 fs-l-4\">\n<section class=\"hero hero-default\">\n<div class=\"container\">\n<div class=\"row\">\n<div class=\"col-lg-10 col-xl-9\">\n<section class=\"hero hero-default\">\n<div class=\"container\">\n<div class=\"row\">\n<div class=\"col-lg-10 col-xl-9\">\n<section class=\"hero hero-default\">\n<div class=\"container\">\n<div class=\"row\">\n<div class=\"col-lg-10 col-xl-9\">\n<h3 class=\"hero-heading\" style=\"text-align: center;\">Assistant Manager- Regulatory<\/h3>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<h4>\u201cTop 10 Interview Questions\u201d<\/h4>\n<ul>\n<li>Can you tell us about yourself?<\/li>\n<li>What interests you about this position?<\/li>\n<li>What are your strengths?<\/li>\n<li>What are your weaknesses?<\/li>\n<li>Can you give an example of a time when you solved a problem creatively?<\/li>\n<li>How do you handle stress and pressure?<\/li>\n<li>How would you describe your work style?<\/li>\n<li>Can you tell us about a time when you had to work with a difficult<\/li>\n<li>colleague or supervisor?<\/li>\n<li>How do you stay organized and prioritize tasks?<\/li>\n<li>What are your long-term career goals?<\/li>\n<\/ul>\n<h4>Document Required:<\/h4>\n<ul>\n<li>Required Documents for This Recruitment: The candidate should have this Document Before Apply Online. Candidates Are Suggested To Read<\/li>\n<li>the Official Notification Before Applying.<\/li>\n<li>Document \u2013 Qualifications certificate with mark sheets.<\/li>\n<li>Passport size Photographs<\/li>\n<li>Signature<\/li>\n<\/ul>\n<h4>How to apply:<\/h4>\n<ul>\n<li>All the eligible candidates can apply for This Job as mentioned below<\/li>\n<li>Read the official notification carefully From the Official Website.<\/li>\n<li>Read the Notification Carefully Before Applying.<\/li>\n<li>Fill out The Application Form (The link Is Given Below)<\/li>\n<li>Attach the Required Document and Passport Size Photo with Signature.<\/li>\n<li>Then Submit. Done.<\/li>\n<\/ul>\n<div class=\"job-title-location fs-12 fs-m-6 fs-l-4\">\n<div class=\"job-title-location fs-12 fs-m-6 fs-l-4\">\n<section class=\"hero hero-default\">\n<div class=\"container\">\n<div class=\"row\">\n<div class=\"col-lg-10 col-xl-9\">\n<section class=\"hero hero-default\">\n<div class=\"container\">\n<div class=\"row\">\n<div class=\"col-lg-10 col-xl-9\">\n<section class=\"hero hero-default\">\n<div class=\"container\">\n<div class=\"row\">\n<div class=\"col-lg-10 col-xl-9\">\n<h3 class=\"hero-heading\" style=\"text-align: center;\">Assistant Manager- Regulatory<\/h3>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<\/div>\n<\/div>\n<p><a href=\"https:\/\/joblagii.com\/company\/johnson-johnson\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-2008 aligncenter\" src=\"https:\/\/exam4sure.com\/jobs\/wp-content\/uploads\/2023\/12\/depositphotos_411304996-stock-illustration-apply-now-button-rounded-sign-300x159.jpg\" alt=\"\" width=\"266\" height=\"141\" \/><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>DESCRIPTION Assistant Manager- Regulatory The Associate Regulatory Affairs Manager has the responsibility to Support regulatory department to ensure efficient and compliant business processes and environment. Assists in the registration of new products\/changes\/renewal licenses by preparing documentation needed for registration submissions in India, Sri Lanka and Bangladesh. The Associate Regulatory Affairs Manager will independently, with minimum [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1047,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[655,1,108],"tags":[758],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Assistant Manager- Regulatory<\/title>\n<meta name=\"description\" content=\"Assistant Manager- Regulatory work from home jobs , online assistant manager remote jobs work from home jobs\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/exam4sure.com\/jobs\/assistant-manager-regulatory\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Assistant Manager- Regulatory\" \/>\n<meta property=\"og:description\" content=\"Assistant Manager- Regulatory work from home jobs , online assistant manager remote jobs work from home jobs\" \/>\n<meta property=\"og:url\" content=\"https:\/\/exam4sure.com\/jobs\/assistant-manager-regulatory\/\" \/>\n<meta property=\"og:site_name\" content=\"Latest Remote Jobs in USA\" \/>\n<meta property=\"article:published_time\" content=\"2024-05-22T04:41:26+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/exam4sure.com\/jobs\/wp-content\/uploads\/2023\/07\/remotee.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"401\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"exam4sure@blogadmin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"exam4sure@blogadmin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/exam4sure.com\/jobs\/assistant-manager-regulatory\/\",\"url\":\"https:\/\/exam4sure.com\/jobs\/assistant-manager-regulatory\/\",\"name\":\"Assistant Manager- Regulatory\",\"isPartOf\":{\"@id\":\"https:\/\/exam4sure.com\/jobs\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/exam4sure.com\/jobs\/assistant-manager-regulatory\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/exam4sure.com\/jobs\/assistant-manager-regulatory\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/exam4sure.com\/jobs\/wp-content\/uploads\/2023\/07\/remotee.jpg\",\"datePublished\":\"2024-05-22T04:41:26+00:00\",\"dateModified\":\"2024-05-22T04:41:26+00:00\",\"author\":{\"@id\":\"https:\/\/exam4sure.com\/jobs\/#\/schema\/person\/911705547976b87bb88c5b29925ed074\"},\"description\":\"Assistant Manager- Regulatory work from home jobs , online assistant manager remote jobs work from home jobs\",\"breadcrumb\":{\"@id\":\"https:\/\/exam4sure.com\/jobs\/assistant-manager-regulatory\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/exam4sure.com\/jobs\/assistant-manager-regulatory\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/exam4sure.com\/jobs\/assistant-manager-regulatory\/#primaryimage\",\"url\":\"https:\/\/exam4sure.com\/jobs\/wp-content\/uploads\/2023\/07\/remotee.jpg\",\"contentUrl\":\"https:\/\/exam4sure.com\/jobs\/wp-content\/uploads\/2023\/07\/remotee.jpg\",\"width\":800,\"height\":401,\"caption\":\"Executive Assistant - 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