{"id":44773,"date":"2025-02-27T10:59:36","date_gmt":"2025-02-27T10:59:36","guid":{"rendered":"https:\/\/www.whitehattoolbox.com\/jobs\/cmc-associate-manager-outsourced-opportunity-for-3-years\/"},"modified":"2025-02-27T10:59:36","modified_gmt":"2025-02-27T10:59:36","slug":"cmc-associate-manager-outsourced-opportunity-for-3-years","status":"publish","type":"post","link":"https:\/\/www.whitehattoolbox.com\/jobs\/cmc-associate-manager-outsourced-opportunity-for-3-years\/","title":{"rendered":"CMC Associate Manager (outsourced opportunity for 3 years)"},"content":{"rendered":"<p><b>JOB DESCRIPTION:<\/b><span class=\"br\"><\/span><b>Job Title<\/b><span class=\"br\"><\/span>CMC Associate Manager (out sourced opporunity for 3 years)<span class=\"br\"><\/span>About Abbott<span class=\"br\"><\/span>Abbott is a global healthcare leader, creating breakthrough science to improve people\u2019s health. We\u2019re always looking towards the future, anticipating changes in medical science and technology.<span class=\"br\"><\/span>Working at Abbott<span class=\"br\"><\/span>At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: <\/p>\n<ul>\n<li>Career development with an international company where you can grow the career you dream of .<\/li>\n<li>A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.<\/li>\n<li>A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.<\/li>\n<\/ul>\n<p><b>The Opportunity<\/b><span class=\"br\"><\/span>This position works out of our Egypt affiliate in the Established Pharmaceutical Division where we are committed to bringing the benefits of our trusted medicines to more people in the world\u2019s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women&#8217;s health, cardiometabolic, pain management\/central nervous system, and respiratory.<span class=\"br\"><\/span>This position in partnership with the EM CMC Regulatory support the various aspects of marketing authorization submission management processes. Will help manage submission content for Drug Substance and Drug Product, and to provide guidance on structure and content placement within CTD registration submissions and to provide assistance with submission related to Egyptian Drug Authority.<span class=\"br\"><\/span>What You\u2019ll Do:<\/p>\n<ul>\n<li>Develop, plan and execute appropriate regulatory strategies and on agreed-upon priorities through effective partnership with EM-CMC Regulatory Scientists and other functional representatives, such as TS\/MS (process and technology transfers), manufacturing, quality control and quality assurance.<\/li>\n<li>Be a responsible party for preparing CMC CTD content consistent with approved manufacturing changes, technical reports, and procedural requirements.<\/li>\n<li>Partner with the EM-CMC Regulatory Scientist to plan and prepare submission content for marketed products to support management of post-approval changes.<\/li>\n<li>Manage submission timelines with relevant teams (e.g. supply chain, QC, manufacturing), monitor approval status and communicate change status in a timely manner.<\/li>\n<li>Partner with Affiliate RA to effectively support product lifecycle maintenance such as site registrations, Tech transfers, products renewal as well as license expiry, where applicable.<\/li>\n<li>In conjunction with Affiliate Regulatory Associates and EM-CMC Regulatory Scientists, may be involved in the management of some GMP documents, if applicable.<\/li>\n<li>Review\/Approve regulatory documents such as: full and core CMC Dossiers (via Darius), variation packages, post-approval commitments with Egyptian Drug Authority and answers to questions received from EDA.<\/li>\n<li>Lead, Influence, Partner<\/li>\n<li>Create an environment within the Regulatory Area and CFT that encourages open discussions on issues to achieve a robust outcome on project decisions. Constructively challenge teams to reach the best solutions to issues.<\/li>\n<li>Leverage internal forums to continue to develop and share regulatory expertise to meet critical product registration timelines and CTD submission structure and content requirements.<\/li>\n<li>Communicate effectively to guide and influence within work group\/function regarding life-cycle management processes<\/li>\n<li>Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues across multiple functions and geographies<\/li>\n<li>Change Control management: preparation of change control request form (CCRF), regulatory &#038; Cross functional assessment vis Track wise system.<\/li>\n<li>Provide regulatory KPIs and regulatory highlights to the reporting manager on a monthly basis.<\/li>\n<\/ul>\n<p><b>Required Qualifications<\/b><\/p>\n<ul>\n<li>Bachelor\u2019s in general science, Pharmaceutical Science, Related Science<\/li>\n<li>Excellent knowledge of written and spoken English and fluent in Arabic.<\/li>\n<li>Computer skills including Microsoft office<\/li>\n<li>Good communication skills and ability to prioritize<\/li>\n<li>Able to make decisions that impact own priorities and allocation of time to meet deadlines<\/li>\n<li>Accuracy, attention to details, reliability, punctuality, and problem-solving skills<\/li>\n<li>Ability to work in a matrix organization<\/li>\n<li>Good team spirit and familiar with project development through cross-functional activities<\/li>\n<li>Strong organizational and negotiation skills<\/li>\n<li>Ability to establish and maintain good regulatory networking internally and externally<\/li>\n<li>Pro-active and well organized with good sense of responsibility<\/li>\n<li>Balanced Judgment \/ Risk based approach<\/li>\n<li>Analytical thinking, hands-on troubleshooting style<\/li>\n<\/ul>\n<p><b>Preferred Qualifications<\/b><\/p>\n<ul>\n<li>6 years working experience in CMC regulatory affairs<\/li>\n<li>Writing of technical reports<\/li>\n<li>In depth knowledge of ICH Guidelines and local market regulations<\/li>\n<li>Experience in providing CMC support of new and\/or marketed pharmaceutical<\/li>\n<li>Ability to provide input, guidance and recommendations in the preparation of the dossiers from different sources to give uniformity of filing.<\/li>\n<\/ul>\n<p> Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.<span class=\"br\"><\/span>Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.<span class=\"br\"><\/span>The base pay for this position is N\/A<span class=\"br\"><\/span>In specific locations, the pay range may vary from the range posted.<span class=\"br\"><\/span>JOB FAMILY: Regulatory<span class=\"br\"><\/span>DIVISION: EPD Established Pharma<span class=\"br\"><\/span>LOCATION: Egypt<br \/>\n       Cairo : KTC Building<span class=\"br\"><\/span>ADDITIONAL LOCATIONS:<span class=\"br\"><\/span>WORK SHIFT: Standard<span class=\"br\"><\/span>TRAVEL: Not specified<span class=\"br\"><\/span>MEDICAL SURVEILLANCE: Not Applicable<span class=\"br\"><\/span>SIGNIFICANT WORK ACTIVITIES: Not Applicable<\/p>\n<p><center><b><a rel=\"nofollow noopener\" href=\"https:\/\/www.careerjet.com.eg\/jobad\/egb1515dd8d3a4080a517801ad194a5b71?affid=0852fd5db5a52cbcd75bf945aa534932\" class=\"button purchase\" target=\"_blank\">Apply Now<\/a> <\/b><\/center><\/p>\n","protected":false},"excerpt":{"rendered":"<p>JOB DESCRIPTION: Job Title CMC Associate Manager (out sourced opporunity for 3 years) About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people\u2019s health. We\u2019re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn<\/p>\n","protected":false},"author":1,"featured_media":44774,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[37,17],"tags":[],"class_list":["post-44773","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-jobs-in-egypt","category-jobs-in-gulf-countries"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/www.whitehattoolbox.com\/jobs\/wp-content\/uploads\/2025\/02\/44773-cmc-associate-manager-outsourced-opportunity-for-3-years.png?fit=1306%2C840&ssl=1","jetpack-related-posts":[{"id":165273,"url":"https:\/\/www.whitehattoolbox.com\/jobs\/were-hiring-non-financial-risks-associate-i\/","url_meta":{"origin":44773,"position":0},"title":"We\u2019re Hiring NON FINANCIAL RISKS ASSOCIATE I","author":"Admin","date":"March 25, 2026","format":false,"excerpt":"Excited to grow your career? 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