{"id":7897,"date":"2026-08-26T13:14:10","date_gmt":"2026-08-26T13:14:10","guid":{"rendered":"https:\/\/globalpharmajobs.org\/?job_listing=syneos-health-hiring-regulatory-consultant"},"modified":"2026-08-26T13:14:10","modified_gmt":"2026-08-26T13:14:10","slug":"syneos-health-hiring-regulatory-consultant","status":"publish","type":"job_listing","link":"https:\/\/globalpharmajobs.org\/?job_listing=syneos-health-hiring-regulatory-consultant","title":{"rendered":"Syneos Health Hiring Regulatory Consultant"},"content":{"rendered":"<p><br \/>\n<\/p>\n<div>\n<h2>Syneos Health Hiring Regulatory Consultant (EU Market \u2013 Module 3 CMC) in Gurgaon | Hybrid Opportunity<\/h2>\n<p>Syneos Health is hiring for the position of <strong>Regulatory Consultant (EU Market \u2013 Module 3 CMC)<\/strong> in <strong>Gurgaon, Haryana (Hybrid work model)<\/strong>. This is a full-time opportunity for experienced regulatory affairs professionals with <strong>4\u20135 years of experience<\/strong> in CMC documentation, post-approval variations, and lifecycle management activities. The role specifically requires strong exposure to <strong>EU and GCC markets<\/strong> and hands-on expertise in <strong>Module 3 (Quality\/CMC) authoring and regulatory submissions<\/strong>. This is a single consultant-level opening within the global regulatory consulting function.<\/p>\n<p>This opportunity is ideal for M.Pharm professionals seeking advanced regulatory affairs careers in global submissions, electronic CTD preparation, EU regulatory strategy, and pharmaceutical lifecycle management within a leading global CRO.<\/p>\n<hr\/>\n<h2>Company Overview<\/h2>\n<p>Syneos Health is a globally recognized, fully integrated biopharmaceutical solutions organization operating across clinical development, regulatory affairs, medical affairs, and commercialization. With more than 29,000 employees across 110 countries, the company partners with pharmaceutical, <a rel=\"nofollow\" target=\"_blank\" class=\"wpil_keyword_link\" title=\"Biotechnology\" href=\"https:\/\/pharmastuff.org\/jobs\/biotechnology\" data-wpil-keyword-link=\"linked\" data-wpil-monitor-id=\"8008\">biotechnology<\/a>, and medical device organizations to accelerate the development and delivery of therapies worldwide.<\/p>\n<div class=\"code-block code-block-16\" style=\"margin: 8px 0; clear: both;\">\n<!-- Push Notification CTA Container --><\/p>\n<div style=\"background-color: #1e293b; border-radius: 10px; padding: 22px; margin: 30px 0; color: #ffffff; position: relative;\">\n<h4 style=\"margin: 0 0 8px 0; font-size: 19px; color: #ffffff;\">\n    \ud83d\udd14 Don&#8217;t Miss Out on <span style=\"color: #fbbf24;\">New Content<\/span><br \/>\n  <\/h4>\n<p style=\"margin: 0 0 16px 0; font-size: 14px; color: #cbd5e1; line-height: 1.5;\">\n    Get instant browser notifications for key updates and insights. <span style=\"color: #fbbf24; text-decoration: underline;\">Zero spam, unsubscribe anytime.<\/span>\n  <\/p>\n<p>  <button id=\"perfecty-custom-cta-btn\" type=\"button\" style=\"background-color: #fbbf24; color: #0f172a; border: none; padding: 12px 22px; font-weight: 700; border-radius: 6px; cursor: pointer; font-size: 15px;\"><br \/>\n    Turn On Notifications<br \/>\n  <\/button><\/p>\n<p>  <!-- Hidden Friendly Unblock Instructions Card --><\/p>\n<div id=\"push-unblock-guide\" style=\"display: none; margin-top: 18px; padding: 16px; background-color: #0f172a; border-left: 4px solid #fbbf24; border-radius: 6px; font-size: 14px; color: #f8fafc;\">\n<p style=\"margin: 0 0 10px 0; font-weight: 700; color: #fbbf24; font-size: 15px;\">\n      \u26a0\ufe0f Notifications are currently paused in your browser\n    <\/p>\n<p style=\"margin: 0 0 12px 0; line-height: 1.4; color: #cbd5e1;\">\n      To enable instant alerts for this site, follow these 3 quick steps:\n    <\/p>\n<ol style=\"margin: 0; padding-left: 20px; line-height: 1.6; color: #f8fafc;\">\n<li>Click the <strong>Lock \/ Tune icon (\ud83d\udd12 or \ud83c\udf9b\ufe0f)<\/strong> next to the website URL in your address bar at the top.<\/li>\n<li>Find <strong>Notifications<\/strong> and change the setting to <strong>Allow<\/strong>.<\/li>\n<li><strong>Refresh<\/strong> this page and click the button again.<\/li>\n<\/ol><\/div>\n<\/div>\n<\/div>\n<p>Syneos Health has supported a significant proportion of FDA-approved drugs and EMA-authorized products in recent years. Its regulatory consulting teams work on complex global submissions, product registrations, lifecycle strategies, and agency interactions across multiple therapeutic areas.<\/p>\n<p>The organization promotes a collaborative and performance-driven culture, offering structured career progression, therapeutic training, and exposure to multinational regulatory environments. Working here means contributing to the global development of life-changing medicines while operating in a compliance-focused, innovation-driven ecosystem.<\/p>\n<hr\/>\n<h2>Job Role &amp; Responsibilities<\/h2>\n<p>The Regulatory Consultant will provide regulatory and technical support for assigned product development programs, with a strong focus on CMC Module 3 documentation and EU market submissions. The role requires independent management of regulatory activities for both non-complex and complex submissions.<\/p>\n<h3>CMC Module 3 Authoring &amp; Lifecycle Management<\/h3>\n<ul>\n<li>Author and review CMC (Chemistry, Manufacturing and Controls) sections of regulatory submissions<\/li>\n<li>Prepare documentation for post-approval variations and lifecycle management activities<\/li>\n<li>Support EU and GCC market regulatory requirements for quality modules<\/li>\n<li>Ensure technical accuracy, consistency, and compliance with regional guidelines<\/li>\n<\/ul>\n<h3>Regulatory Submissions &amp; Documentation<\/h3>\n<ul>\n<li>Contribute to preparation of regulatory submission packages including IND, NDA, MAA, CTD, and electronic submissions<\/li>\n<li>Conduct gap analysis based on existing product data and regional regulatory requirements<\/li>\n<li>Prepare administrative and technical components of submission dossiers<\/li>\n<li>Support preparation of briefing packages for scientific advice and regulatory meetings<\/li>\n<\/ul>\n<h3>Project &amp; Client Management<\/h3>\n<ul>\n<li>Manage day-to-day regulatory activities in line with agreed timelines and scope of work<\/li>\n<li>Participate in multidisciplinary project teams involving clinical, quality, and manufacturing experts<\/li>\n<li>Act as subject matter expert for CMC-related troubleshooting and regulatory strategy discussions<\/li>\n<li>Provide input for regulatory service proposals and support business development discussions<\/li>\n<\/ul>\n<h3>Compliance &amp; Quality Support<\/h3>\n<ul>\n<li>Ensure alignment with global regulatory requirements and internal SOPs<\/li>\n<li>Participate in internal and external audits<\/li>\n<li>Contribute to development and maintenance of regulatory SOPs and documentation standards<\/li>\n<li>Support cross-functional initiatives related to regulatory excellence and continuous improvement<\/li>\n<\/ul>\n<h3>Team Leadership &amp; Knowledge Sharing<\/h3>\n<ul>\n<li>Provide guidance and oversight to team members as required<\/li>\n<li>Prepare training materials and share regulatory best practices internally and externally<\/li>\n<li>Maintain individual training records and ensure completion of mandatory compliance training<\/li>\n<\/ul>\n<p>This position requires strong analytical ability, attention to detail, and the capability to handle multiple concurrent regulatory projects with varying requirements.<\/p>\n<hr\/>\n<h2>Eligibility \/ Qualifications<\/h2>\n<p>This role is intended for experienced regulatory affairs professionals with strong CMC expertise and EU market exposure.<\/p>\n<h3>Educational Qualifications<\/h3>\n<p>M.Pharm, B.Pharm, Master\u2019s in Pharmaceutical Sciences, PhD in Life Sciences or related scientific discipline<\/p>\n<h3>Experience Requirements<\/h3>\n<ul>\n<li>Minimum 4\u20135 years of experience in Regulatory Affairs<\/li>\n<li>Proven experience in Module 3 (CMC) documentation and authoring<\/li>\n<li>Experience in EU and GCC market submissions is mandatory<\/li>\n<li>Exposure to electronic CTD submissions and lifecycle management activities<\/li>\n<\/ul>\n<h3>Technical Competencies<\/h3>\n<ul>\n<li>Knowledge of global regulatory frameworks including EMA and FDA requirements<\/li>\n<li>Familiarity with IND, NDA, MAA, CTD submission structures<\/li>\n<li>Strong understanding of pharmaceutical manufacturing and quality documentation<\/li>\n<li>Advanced proficiency in Microsoft Office applications<\/li>\n<li>Excellent written and verbal English communication skills<\/li>\n<\/ul>\n<h3>Core Skills<\/h3>\n<ul>\n<li>Strong analytical and problem-solving ability<\/li>\n<li>Customer-focused mindset with ability to work independently and in teams<\/li>\n<li>High attention to detail and quality orientation<\/li>\n<li>Ability to manage multiple regulatory projects simultaneously<\/li>\n<\/ul>\n<hr\/>\n<h2>Location &amp; Salary<\/h2>\n<p><strong>Job Location:<\/strong> Gurgaon, Haryana, India<br \/><strong>Work Model:<\/strong> Hybrid<br \/><strong>Employment Type:<\/strong> Full-time<\/p>\n<hr\/>\n<h2>Application Process<\/h2>\n<p>Interested candidates can apply through Syneos Health\u2019s official career portal using the link below:<\/p>\n<p><strong>Apply Online:<\/strong><br \/><a rel=\"nofollow\" target=\"_blank\" href=\"https:\/\/syneoshealth.wd12.myworkdayjobs.com\/Syneos_Health_External_Site\/job\/IND-Remote\/Regulatory-Consultant--CMC-EU--GCC---AU-_25110577\" rel=\"nofollow noopener\" target=\"_blank\">https:\/\/syneoshealth.wd12.myworkdayjobs.com\/Syneos_Health_External_Site\/job\/IND-Remote\/Regulatory-Consultant\u2013CMC-EU\u2013GCC\u2014AU-_25110577<\/a><\/p>\n<p>or You can also share your cv to <a rel=\"nofollow\" target=\"_blank\" class=\"uNTKIXSVhTqFErRXENtjrKtJWDUMLqCWM \" tabindex=\"0\" href=\"http:\/\/pharmastuff.org\/cdn-cgi\/l\/email-protection#12737c737f7b79733c78736b6260737973617a52616b7c777d617a77737e667a3c717d7f\" target=\"_self\" data-test-app-aware-link=\"\"><span class=\"__cf_email__\" data-cfemail=\"b3d2ddd2dedad8d29dd9d2cac3c1d2d8d2c0dbf3c0caddd6dcc0dbd6d2dfc7db9dd0dcde\">[email\u00a0protected]<\/span><\/a>.<\/p>\n<p>Applications are reviewed on an ongoing basis. Early application is recommended.<\/p>\n<hr\/>\n<h2>Frequently Asked Questions (FAQs)<\/h2>\n<p><strong>Who can apply for the Regulatory Consultant (EU Module 3) role?<\/strong><br \/>Candidates with 4\u20135 years of regulatory affairs experience and strong CMC Module 3 authoring exposure can apply.<\/p>\n<p><strong>Is EU market experience mandatory?<\/strong><br \/>Yes. Prior experience in EU and GCC regulatory submissions is required.<\/p>\n<p><strong>Is this role focused on CMC documentation?<\/strong><br \/>Yes. The primary responsibility includes authoring and reviewing Module 3 (CMC) documentation.<\/p>\n<p><strong>Is this a permanent position?<\/strong><br \/>Yes. This is a full-time role under Syneos Health.<\/p>\n<p><strong>Does this role involve global submissions?<\/strong><br \/>Yes. The consultant will support EU and other international regulatory submissions.<\/p>\n<hr\/>\n<h2>Summary Table<\/h2>\n<table>\n<thead>\n<tr>\n<th>Company<\/th>\n<th>Syneos Health<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Vacancies<\/td>\n<td>Regulatory Consultant (EU Market \u2013 Module 3 CMC)<\/td>\n<\/tr>\n<tr>\n<td>Required Education<\/td>\n<td>M.Pharm, B.Pharm, Pharmaceutical Sciences, PhD<\/td>\n<\/tr>\n<tr>\n<td>Experience<\/td>\n<td>4\u20135 Years<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p class=\"job_tags\">Tagged as: <a rel=\"nofollow\" target=\"_blank\" href=\"https:\/\/pharmastuff.org\/job-tag\/cmc\" rel=\"tag\">CMC<\/a>, <a rel=\"nofollow\" target=\"_blank\" href=\"https:\/\/pharmastuff.org\/job-tag\/documentation\" rel=\"tag\">Documentation<\/a>, <a rel=\"nofollow\" target=\"_blank\" href=\"https:\/\/pharmastuff.org\/job-tag\/manufacturing\" rel=\"tag\">Manufacturing<\/a>, <a rel=\"nofollow\" target=\"_blank\" href=\"https:\/\/pharmastuff.org\/job-tag\/regulatory-affairs\" rel=\"tag\">Regulatory Affairs<\/a>, <a rel=\"nofollow\" target=\"_blank\" href=\"https:\/\/pharmastuff.org\/job-tag\/regulatory-submissions\" rel=\"tag\">Regulatory Submissions<\/a><\/p>\n<\/p><\/div>\n<p><br \/>\n<br \/><a href=\"https:\/\/pharmastuff.org\/job\/syneos-health-remote-regulatory-consultant\">Source link <\/a><\/p>\n","protected":false},"author":1,"featured_media":7898,"template":"","meta":{"_promoted":"","_job_location":"","_application":"","_company_name":"","_company_website":"","_company_tagline":"","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job_listing_region":[],"job-categories":[172],"job-types":[2],"job_listing_tag":[],"class_list":["post-7897","job_listing","type-job_listing","status-publish","has-post-thumbnail","hentry","job_listing_category-regulatory-affair","job_listing_type-full-time","job-type-full-time"],"_links":{"self":[{"href":"https:\/\/globalpharmajobs.org\/index.php?rest_route=\/wp\/v2\/job-listings\/7897","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/globalpharmajobs.org\/index.php?rest_route=\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/globalpharmajobs.org\/index.php?rest_route=\/wp\/v2\/types\/job_listing"}],"author":[{"embeddable":true,"href":"https:\/\/globalpharmajobs.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/globalpharmajobs.org\/index.php?rest_route=\/wp\/v2\/media\/7898"}],"wp:attachment":[{"href":"https:\/\/globalpharmajobs.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=7897"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/globalpharmajobs.org\/index.php?rest_route=%2Fwp%2Fv2%2Fjob_listing_region&post=7897"},{"taxonomy":"job_listing_category","embeddable":true,"href":"https:\/\/globalpharmajobs.org\/index.php?rest_route=%2Fwp%2Fv2%2Fjob-categories&post=7897"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/globalpharmajobs.org\/index.php?rest_route=%2Fwp%2Fv2%2Fjob-types&post=7897"},{"taxonomy":"job_listing_tag","embeddable":true,"href":"https:\/\/globalpharmajobs.org\/index.php?rest_route=%2Fwp%2Fv2%2Fjob_listing_tag&post=7897"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}