{"id":102316,"date":"2026-07-17T12:54:26","date_gmt":"2026-07-17T12:54:26","guid":{"rendered":"https:\/\/jobs.dataaxisnode.com\/kenya\/uncategorized\/regulatory-affairs-associate-fixed-term-contract\/"},"modified":"2026-07-17T12:54:26","modified_gmt":"2026-07-17T12:54:26","slug":"regulatory-affairs-associate-fixed-term-contract","status":"publish","type":"post","link":"https:\/\/jobs.dataaxisnode.com\/kenya\/jobs\/nairobi\/regulatory-affairs-associate-fixed-term-contract\/","title":{"rendered":"Regulatory Affairs Associate | Fixed-term contract"},"content":{"rendered":"<p><script type=\"application\/ld+json\">{\"@context\": \"https:\/\/schema.org\/\", \"@type\": \"JobPosting\", \"title\": \"Regulatory Affairs Associate | Fixed-term contract\", \"description\": \"Job Purpose\\nThe Regulatory Affairs Associate provides critical operational and execution-focused support to the Drug Regulatory Affairs DRA Lead. This role is responsible for driving regulatory submissions within the Roche East Africa affiliate. The successful candidate will support the end-to-end lifecycle of post-marketing variations, safety submissions, and renewals, while maintaining real-time data integrity in Roche\u2019s Global Regulatory Information Management Systems RIMS.\\nMain Responsibilities\\nRegulatory Submission & Strategy Execution\\nLocal Plan Management:\u00a0Collaborate closely with internal stakeholders to execute the affiliate regulatory strategy, ensuring product registrations align with business timelines.\\nDossier Compilation & Filing:\u00a0Prepare, review, and submit high-quality regulatory applications to local Health Authorities to secure timely product approvals.\\nLifecycle Management & Compliance\\nPortfolio Maintenance:\u00a0Guarantee uninterrupted product supply by proactively managing post-approval lifecycle activities, including variations, safety labeling updates, GMP renewals, and timely registration renewals.\\nData Integrity & Systems Management:\u00a0Maintain real-time accuracy in Roche\u2019s Global Regulatory Information Management Systems RIMS, precisely logging submission and approval metrics to ensure global compliance transparency.\\nRegulatory Intelligence:\u00a0Continually monitor the local regulatory landscape for shifting guidelines, assess their impact on the portfolio, and communicate updates effectively to local stakeholders and Global Regulatory teams.\\nPharmacovigilance:\u00a0Act as assigned back up Qualified Person for Pharmacovigilance\\nCross-Functional Partnership & Agility\\nCollaborative Liaison:\u00a0Act as an agile regulatory partner across departments Medical, Commercial, PV and Quality to provide regulatory insights that support business continuity.\\nStakeholder Engagement:\u00a0Support the DRA Lead in fostering transparent, professional relationships with official health authorities and industry bodies.\\nQualifications & Experience\\nEducation:\u00a0Minimum of a Bachelor of Pharmacy B.Pharm degree.\\nProfessional Registration:\u00a0Valid registration with the Pharmacy and Poisons Board PPB, Kenya.\\nExperience:\u00a02 to 3 years of hands-on regulatory affairs experience within a multinational pharmaceutical environment or a specialized life sciences organization.\\nCore Skills & Competencies\\nAutonomy & Drive:\u00a0A highly motivated self-starter with meticulous attention to detail; proven ability to translate general concepts into compliant, successful regulatory outcomes with minimal supervision.\\nAgility & Prioritization:\u00a0Demonstrated capability to manage multiple complex portfolios simultaneously, dynamically prioritizing tasks to meet strict external and internal deadlines.\\nCommunication Excellence:\u00a0Exceptional written and verbal communication skills in English, with the interpersonal savviness required to navigate health authority networks and cross-functional corporate teams.\\nSolution-Oriented Mindset:\u00a0Strong analytical skills paired with a collaborative approach to solving compliance challenges in alignment with affiliate objectives.\\nIntegrity:\u00a0High ethical standards and a strict adherence to corporate compliance, local regulations, and industry codes of conduct.\", \"datePosted\": \"2026-07-16\", \"hiringOrganization\": {\"@type\": \"Organization\", \"name\": \"Roche Kenya\"}, \"jobLocation\": {\"@type\": \"Place\", \"address\": {\"@type\": \"PostalAddress\", \"addressLocality\": \"Nairobi\", \"addressCountry\": \"KE\"}}, \"directApply\": true, \"validThrough\": \"2026-07-30T23:59:59\", \"employmentType\": \"CONTRACTOR\"}<\/script><\/p>\n<p><strong>Company:<\/strong> Roche Kenya<\/p>\n<p><strong>Location:<\/strong> Nairobi<\/p>\n<p><strong>Job Type:<\/strong> Contract<\/p>\n<p><strong>Apply Before:<\/strong> 2026-07-30<\/p>\n<h3>Job Description<\/h3>\n<p>Job Purpose<br \/>The Regulatory Affairs Associate provides critical operational and execution-focused support to the Drug Regulatory Affairs DRA Lead. This role is responsible for driving regulatory submissions within the Roche East Africa affiliate. The successful candidate will support the end-to-end lifecycle of post-marketing variations, safety submissions, and renewals, while maintaining real-time data integrity in Roche\u2019s Global Regulatory Information Management Systems RIMS.<br \/>Main Responsibilities<br \/>Regulatory Submission &#038; Strategy Execution<br \/>Local Plan Management:\u00a0Collaborate closely with internal stakeholders to execute the affiliate regulatory strategy, ensuring product registrations align with business timelines.<br \/>Dossier Compilation &#038; Filing:\u00a0Prepare, review, and submit high-quality regulatory applications to local Health Authorities to secure timely product approvals.<br \/>Lifecycle Management &#038; Compliance<br \/>Portfolio Maintenance:\u00a0Guarantee uninterrupted product supply by proactively managing post-approval lifecycle activities, including variations, safety labeling updates, GMP renewals, and timely registration renewals.<br \/>Data Integrity &#038; Systems Management:\u00a0Maintain real-time accuracy in Roche\u2019s Global Regulatory Information Management Systems RIMS, precisely logging submission and approval metrics to ensure global compliance transparency.<br \/>Regulatory Intelligence:\u00a0Continually monitor the local regulatory landscape for shifting guidelines, assess their impact on the portfolio, and communicate updates effectively to local stakeholders and Global Regulatory teams.<br \/>Pharmacovigilance:\u00a0Act as assigned back up Qualified Person for Pharmacovigilance<br \/>Cross-Functional Partnership &#038; Agility<br \/>Collaborative Liaison:\u00a0Act as an agile regulatory partner across departments Medical, Commercial, PV and Quality to provide regulatory insights that support business continuity.<br \/>Stakeholder Engagement:\u00a0Support the DRA Lead in fostering transparent, professional relationships with official health authorities and industry bodies.<br \/>Qualifications &#038; Experience<br \/>Education:\u00a0Minimum of a Bachelor of Pharmacy B.Pharm degree.<br \/>Professional Registration:\u00a0Valid registration with the Pharmacy and Poisons Board PPB, Kenya.<br \/>Experience:\u00a02 to 3 years of hands-on regulatory affairs experience within a multinational pharmaceutical environment or a specialized life sciences organization.<br \/>Core Skills &#038; Competencies<br \/>Autonomy &#038; Drive:\u00a0A highly motivated self-starter with meticulous attention to detail; proven ability to translate general concepts into compliant, successful regulatory outcomes with minimal supervision.<br \/>Agility &#038; Prioritization:\u00a0Demonstrated capability to manage multiple complex portfolios simultaneously, dynamically prioritizing tasks to meet strict external and internal deadlines.<br \/>Communication Excellence:\u00a0Exceptional written and verbal communication skills in English, with the interpersonal savviness required to navigate health authority networks and cross-functional corporate teams.<br \/>Solution-Oriented Mindset:\u00a0Strong analytical skills paired with a collaborative approach to solving compliance challenges in alignment with affiliate objectives.<br \/>Integrity:\u00a0High ethical standards and a strict adherence to corporate compliance, local regulations, and industry codes of conduct.<\/p>\n<h3>How to Apply<\/h3>\n<p>Interested and qualified? Go to Roche Kenya on careers.roche.com to apply<br \/>Build your CV for free. Download in different templates.<\/p>\n<p><a href=\"https:\/\/www.myjobmag.co.ke\/apply-now\/1280415\" target=\"_blank\" rel=\"noopener\" style=\"display:inline-block;padding:10px 20px;background:#2271b1;color:#fff;text-decoration:none;border-radius:4px;\">Apply Now<\/a><\/p>\n<p><small>Source: MyJobMag<\/small><\/p>\n<p><!-- job-expiry: 2026-07-30 --><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Company: Roche Kenya Location: Nairobi Job Type: Contract Apply Before: 2026-07-30 Job Description Job PurposeThe Regulatory Affairs Associate provides critical operational and execution-focused support to the Drug Regulatory Affairs DRA Lead. This role is responsible for driving regulatory submissions within the Roche East Africa affiliate. The successful candidate will support the end-to-end lifecycle of post-marketing [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1408,1409],"tags":[1443,1413,1412,1434],"class_list":["post-102316","post","type-post","status-publish","format-standard","hentry","category-jobs","category-nairobi","tag-contract","tag-job-listing","tag-myjobmag","tag-roche-kenya"],"_links":{"self":[{"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/posts\/102316","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/comments?post=102316"}],"version-history":[{"count":0,"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/posts\/102316\/revisions"}],"wp:attachment":[{"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/media?parent=102316"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/categories?post=102316"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/kenya\/wp-json\/wp\/v2\/tags?post=102316"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}