Regulatory Affairs Manager

🏢 Iqvia
📍 EgyptFull-timeOn-site
📅 Posted: 1w ago🔄 Updated: 1w ago
CV%
✨ AI Summary
IQVIA is seeking a highly experienced Global Regulatory Affairs Lead to provide regulatory leadership and support strategic client growth. This role involves leading regulatory strategy, advising on submissions and lifecycle management, and supporting proposal development and business development. The ideal candidate will have a degree in Life Sciences or a related discipline, significant global and regional Regulatory Affairs experience, strong knowledge of diverse market regulatory requirements, and experience with CTD/eCTD submissions. Excellent client-facing, stakeholder management, communication, presentation, and influencing skills are crucial, as is the ability to work independently in a fast-paced environment. Experience in consulting, CRO, or client services is a plus.
Required Skills
Business, Sales & Management
HR ManagementBusiness DevelopmentCommercial AwarenessProposal Development
Other
eCTD submissionsregulatory operationsregulatory intelligenceregulatory strategyPublishingCTD submissions
Soft Skills & Professional Competencies
Stakeholder Management
Information Technology
Data Labeling
Requirements
Requires a degree in Life Sciences or a related discipline and significant Regulatory Affairs experience in global and regional environments. Must have a strong understanding of regulatory requirements across multiple markets, experience preparing and managing CTD/eCTD submissions, and strong client-facing and stakeholder management capabilities. Experience supporting proposal development and business development activities, along with commercial awareness and strong communication, presentation, and influencing skills are essential.
Description
Combine regulatory expertise with strategic business impact.IQVIA is seeking a highly experienced Global Regulatory Affairs Lead to provide regulatory leadership while supporting strategic client growth initiatives. This is a unique opportunity for a regulatory professional who enjoys both scientific and commercial conversations, and who can confidently advise clients while helping develop innovative regulatory solutions.In this highly visible role, you will partner with clients, business development teams and regulatory experts across multiple regions. You will shape regulatory strategies, contribute to proposals and bid defenses, and support the successful delivery of complex global and regional projects. The role combines regulatory leadership with significant client engagement and business development exposure.What You'll DoLead regulatory strategy and execution for regional and global client projects Provide expert guidance on regulatory submissions, lifecycle management and regulatory intelligenceSupport proposal development, bid defenses and strategic client engagements Partner with business development teams to identify and pursue growth opportunitiesBuild strong relationships with clients and act as a trusted regulatory advisor Support health authority interactions and regulatory planning activitiesEnsure successful delivery of projects within scope, timeline and quality expectationsMentor colleagues and contribute to regulatory best practicesDrive continuous improvement initiatives across regulatory operationsWhat We're Looking ForDegree in Life Sciences or a related disciplineSignificant Regulatory Affairs experience in global and regional environments Strong understanding of regulatory requirements across multiple markets Experience preparing and managing CTD/eCTD submissionsStrong client-facing and stakeholder management capabilitiesExperience supporting proposal development, business development or pre-award activitiesCommercial awareness and the ability to identify growth opportunitiesStrong communication, presentation and influencing skillsAbility to work independently in a fast-paced, client-focused environmentNice to HaveExperience participating in bid defenses or client pitchesExperience supporting business development teamsSubject matter expertise in areas such as lifecycle management, labeling, publishing, CMC or regulatory operationsExperience working in consulting, CRO or client services environmentsIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
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🎯 Overalli74%
⚡ Skillsi85%
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Ontology Match: 85.0
Matched:✓ Requirements Matching✓ Ontology Skills Mapping
📜 Eligibilityi49%
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Local: 19600%
🏗️ Career Fiti91%
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Seniority: 91.0
📋 Requirementsi67%
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Domain: 67.0
🔥 Motivationi78%
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Title Fit: 78.00