em regulatory affairs manager (biosimilar)

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em regulatory affairs manager (biosimilar) Jobs in Cairo

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em regulatory affairs manager biosimilar

Abbott

<div>
 
 Primary Job Function :
 
 
 
 <ul>
 <li>
 Supports affiliates in the execution of registration plans, ensuring timely and compliant submissions across EM markets including but not limited to Biosimilars
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 Monitors progress of product registrations and maintains oversight of regional regulatory timelines and requirements.
 </li>
 <li>
 Provides coordination and operational support to local Regulatory Affairs teams to ensure alignment and regulatory compliance.
 </li>
 <li>
 Support collecting and interpreting the guidelines related to Biosimilars
 
 
 </li>
 </ul>
 
 Core Job Responsibilities :
 
 
 
 <ul>
 <li>
 Product registrations /Submissions
 </li>
 <li>
 Coordinate the execution of the regulatory strategies ensuring close monitoring and follow up with the affiliates and timely reporting.
 </li>
 <li>
 Relationships &amp; Cross Functional teamwork
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 Ensure good collaboration and relationship with the regulatory teams in the affiliate and the emerging markets
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 Supports the internal stakeholders for any regulatory affairs ad-hoc request
 </li>
 <li>
 Affiliate Coordination
 </li>
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 Maintains effective working relationships with local RA teams and global RA teams
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 <li>
 Ensure proper coordination between the RA affiliates and stakeholders in the defined areas
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 Compliance across lifecycles
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 Supports the coordination of new product registration activities ensuring alignment with regulatory requirements and business timelines.
 </li>
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 Provides day‑to‑day support to ensure products remain compliant throughout their lifecycle.
 </li>
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 Regulatory Operations
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 Coordinates the preparation and submission of registration dossiers, variations, renewals, and clinical trial applications, ensuring timely execution
 </li>
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 Monitors timelines for key submissions (e.g., new registrations, variations, CCDS updates, PSURs, license renewals) and supports affiliates to ensure continuity of product availability.
 
 
 </li>
 </ul>
 
 Position Accountability/Scope :
 
 
 
 Accountable that the business remains compliance with all regulatory aspects (local and Abbott policy) and all regulatory agency submission materials are within timeliness, accuracy, comprehensiveness and compliance with regulatory standards.
 
 
 
 Minimum Education :
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s Degree of Pharmacy or
 </li>
 <li>
 Bachelor&rsquo;s Degree of Life Science or
 </li>
 <li>
 Bachelor&rsquo;s Degree of Science
 
 
 </li>
 </ul>
 
 Minimum Experience/Training Required :
 
 
 
 <ul>
 <li>
 At least 5 years of working experience in similar roles
 </li>
 <li>
 Understanding of regulatory affairs in pharmaceutical environment, experience interfacing with government and regulatory agencies and proven skills in developing and implementing successful regulatory strategies. Strong communication skills to effectively present regulatory information to management and government agencies
 
 
 </li>
 </ul>
 
 Management Skills
 
 
 
 <ul>
 <li>
 Uses resources effectively and efficiently.
 </li>
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 Able to plan, prioritize and delegate tasks to project team as needed to ensure timely completion of projects.
 </li>
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 Maintain and operate within budget.
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 Capable of analyzing and investigating issues and problem solving.
 
 
 </li>
 </ul>
 
 Communication Skills
 
 
 
 <ul>
 <li>
 Effectively practices listening skills before responding to issues.
 </li>
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 Effectively writes, presents and communicates information to internal and external clients, including divisional management.
 </li>
 <li>
 Effective negotiation skills.
 
 
 </li>
 </ul>
 
 Skills
 
 
 
 
 Total Quality Management (TQM) Skills
 
 
 
 <ul>
 <li>
 Demonstrates the ability to exercise good judgment on regulatory and compliance issues.
 </li>
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 Demonstrates an understanding of the appropriate regulatory requirements and applies this understanding to all job responsibilities.
 </li>
 </ul>
</div>

EM Regulatory Affairs Manager (Biosimilar)

Amgen

<div>
 
 HOW MIGHT YOU DEFY IMAGINATION?
 
 
 
 If you feel like you&rsquo;re part of something bigger, it&rsquo;s because you are. At Amgen our shared mission&mdash;to serve patients&mdash;drives all that we do. It is key to our becoming one of the world&rsquo;s leading biotechnology companies. We are global collaborators who achieve together&mdash;researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It&rsquo;s time for a career you can be proud of. Join us.
 
 
 
 SENIOR ASSOCIATE REGULATORY AFFAIRS
 
 
 
 
 What You Will Do
 
 
 
 In this vital role you will assist in the local coordination and execution of regulatory submissions in compliance with Amgen corporate standards and national regulatory requirements, and Regulatory Affairs processes and deliverables for the ELI markets Egypt, Jordan, Iraq and Lebanon.
 
 
 <ul>
 <li>
 Ensure regulatory submissions are made on time and meet Amgen&rsquo;s corporate and local regulatory requirements
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 <li>
 Responsible for completion of regulatory files for submission. (Prepare/Receive files and submit them to regulatory authorities within the defined and agreed submission/approval dates) and according to guidelines and requirements
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 Manufacturing site registration and license maintenance
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 Responsible for coordinating with the International regulatory team to ensure right first-time dossiers are provided
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 Coordinate and respond to the requests by authorities during the evaluation process and check the correct handling of deficiency letter within a specific timeframe in order not to delay MOH approvals
 </li>
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 Establish effective communication and continuous follow-up with the external agencies &amp; distributors to ensure timely submissions and approvals of all company&rsquo;s applications
 </li>
 <li>
 Monitoring of emerging guidelines and changes affecting business and communication to relevant internal customers
 </li>
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 Providing guidance on the approval processes to internal stakeholders within the region and providing regulatory input for launch planning
 </li>
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 Maintenance of all lifecycle activities/ Product renewal license details by accurately preparing filling submissions and approval within the preset global timelines -accountable for overall accuracy and compliance
 </li>
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 Ensure alignment of regulatory objectives with regional / global regulatory objectives and commercial plans
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 Accountable for solving all supply issues related to regulatory activities.
 </li>
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 To provide regulatory intelligence
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 Ensure compliance with company's SOPs and working practices for Good Regulatory Practice
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 Management of documentation archiving and record keeping according to SOP and local legislation
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 Contact for agency interactions for portfolio of products and coordinating and reviewing briefing documents and/or other submissions for meetings with Regulatory agencies
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 Collate, distribute, exchange and archive regulatory information with colleagues across the business
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 Participate in regulatory and affiliate process improvements initiatives
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 Review promotion and non-promotion materials to ensure compliance with local license, company procedures and Code of Practice
 
 
 </li>
 </ul>
 
 BE PART OF OUR TEAM
 
 
 
 Reporting to the Regulatory Affairs Manager for ELI, you would be joining a team of regulatory professionals passionate about delivering the best outcomes for our medicines to patients.
 
 
 
 What We Expect Of You
 
 
 
 We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
 
 
 <ul>
 <li>
 Pharmacy Bachelor&rsquo;s degree
 </li>
 <li>
 2-3 years of directly related experience in regulatory affairs (ELI markets)
 </li>
 <li>
 Knowledge and awareness of the relevant regulatory guidelines and legislation for ELI markets
 </li>
 <li>
 Strong communication skills both verbal and written
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 <li>
 Organizational skills &amp; developing regulatory project management skills
 
 
 </li>
 </ul>
 
 Thrive
 
 
 
 
 What You Can Expect Of Us
 
 
 
 As we work to develop treatments that take care of others, so we work to care for our teammates&rsquo; professional and personal growth and well-being.
 
 
 <ul>
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 Vast opportunities to learn and move up and across our global organization
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 Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
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 Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
 
 
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 </ul>
 
 Apply now for a career that defies imagination
 
 
 
 In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
 
 
 
 careers.amgen.com
 
 
 
 Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
</div>

Senior Associate Regulatory Affairs

Dkhoon Emirates

<div>
 
 
 Job Title: International Legal Officer
 
 
 
 
 Location: Egypt
 
 
 
 
 Employment Type: Full-time
 
 
 
 
 
 
 
 Job Summary
 
 
 
 
 
 
 
 We are looking for an experienced International Legal Officer to join our team in Egypt. The successful candidate will provide legal support for the company's international operations, ensuring compliance with applicable laws, reviewing commercial agreements, and managing legal matters across multiple jurisdictions.
 
 
 
 
 
 
 
 Key Responsibilities :
 
 
 
 
 
 <ul>
 
 <li>
 
 Draft, review, and negotiate commercial contracts, NDAs, supplier agreements, and service contracts.
 
 </li>
 
 <li>
 
 Ensure compliance with Egyptian laws and international legal requirements.
 
 </li>
 
 <li>
 
 Provide legal advice on corporate, commercial, labor, and regulatory matters.
 
 </li>
 
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 Coordinate with external legal counsel and government authorities.
 
 </li>
 
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 Support company registrations, licensing, and corporate governance activities.
 
 </li>
 
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 Monitor legal and regulatory updates affecting international business operations.
 
 </li>
 
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 Assist in resolving legal disputes and managing litigation when required.
 
 </li>
 
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 Develop and maintain legal policies, procedures, and compliance documentation.
 
 </li>
 
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 Conduct legal research and provide practical recommendations to management.
 
 </li>
 
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 Maintain organized legal records and documentation.
 
 </li>
 
 </ul>
 
 
 
 
 
 Qualifications :
 
 
 
 
 
 <ul>
 
 <li>
 
 Bachelor's degree in Law (LL.B.) from a recognized university.
 
 </li>
 
 <li>
 
 3&ndash;5 years of experience in corporate, commercial, or international legal affairs.
 
 </li>
 
 <li>
 
 Strong knowledge of Egyptian corporate and labor laws.
 
 </li>
 
 <li>
 
 Experience reviewing and drafting contracts in English and Arabic.
 
 </li>
 
 <li>
 
 Excellent legal research, analytical, and negotiation skills.
 
 </li>
 
 <li>
 
 Strong communication and interpersonal skills.
 
 </li>
 
 <li>
 
 Ability to manage multiple priorities and work under pressure.
 
 </li>
 
 <li>
 
 Fluent in English and Arabic (written and spoken).
 
 </li>
 </ul>
</div>

International Legal Officer

Sandoz Egypt

<div>
 <ul>
 <li>
 Responsible for implementing regulatory strategy and managing operational activities for the assigned SSA countries.
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 <li>
 Responsible to coordinate and follow up with all responsible distributors and local representatives and scientific offices on the geographical region of SSA.
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 <li>
 Provides input into global regulatory strategy and contributes to Regulatory Functional Plan and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for the assigned SSA countries.
 </li>
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 Find synergies between countries, align with different stakeholders to obtain approvals and unlock struggles with appointments and long timelines.
 </li>
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 Partners with regions align regulatory strategy in order to fulfil business objectives -Implements Regulatory Functional Plan across the assigned SSA countries.
 </li>
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 Determines requirements and sets objectives for Health Authority interactions .
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 Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.
 </li>
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 Develops and implements plans for timely response to Health Authority requests and coordinates responses.
 </li>
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 Drives coordination, planning, and submission of dossiers in the assigned SSA countries.
 </li>
 <li>
 Review of global dossier summary documents.
 </li>
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 Develops and implements plans to avoid/minimize clock stops during submission review.
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 <li>
 Responsible to maintain KPIs of all compliance and safety metrics from regulatory perspective.
 </li>
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 Responsible for facilitating timely submission and approval of dossier with Health Authority under the guidance of the global and regional RA
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 <li>
 Erroneous decisions result in critical delays and modifications to projects or operations; cause substantial expenditure of additional time, human resources, and funds; and jeopardize future business activity -Contributes to and often leads the development of departmental goals and objectives.
 
 
 </li>
 </ul>
 
 Key Performance Indicators
 
 
 
 <ul>
 <li>
 Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data.
 </li>
 <li>
 Successful management of local distributors and scientific offices in countries and ensure KPI monitoring and stakeholder management.
 </li>
 <li>
 Identification of main Health Authority issues
 </li>
 <li>
 Participation in relevant regulatory Boards leading to valuable input from these Boards.
 </li>
 <li>
 Successful Participation in Health Authority interactions to achieve business objectives.
 </li>
 <li>
 Adherence to Sandoz policy and guidelines
 </li>
 <li>
 Project &amp; stakeholder feedback
 
 
 </li>
 </ul>
 
 Minimum Requirements
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in pharmacy or related field
 </li>
 <li>
 7+ years of relevant regulatory experience with 3+ years in managerial role within pharmaceutical industry
 </li>
 <li>
 Experience in regulatory affairs in the region of SSA and working the distributors and country scientific offices.
 </li>
 <li>
 Excellent knowledge of local legislation requirements in the field of pharmaceutical registration
 </li>
 <li>
 Experience in interacting with government authorities
 </li>
 <li>
 Strong knowledge of labeling requirements and GxP documentations
 </li>
 <li>
 Attention to detail, organizational skills and ability to work with documentation
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 <li>
 Fluent in English and Arabic . French is a plus.
 </li>
 </ul>
</div>

Regulatory Affairs Senior Manager, Sub‑Saharan Africa

DHL Express

<div>
 Role Purpose
 
 
 The IT Program Delivery Manager leads the end-to-end execution of IT programs and projects for DHL Express Egypt while driving the strategic ownership of the Digital Customer Solutions function. This position serves as the critical link between structured program governance and live, customer-facing operations, ensuring customer shipping platforms remain highly available, high-performing, and fully compliant with changing national customs and regulatory mandates.
 
 
 Key Responsibilities
 
 
 
 <ul>
 <li>
 Lead the end-to-end planning, execution, and monitoring of local IT programs and projects to achieve business objectives across scope, schedule, resources, budget, and quality.
 </li>
 <li>
 Manage the delivery of the local customs and regulatory technology portfolio, specifically handling integrations such as Nafeza and Advanced Cargo Information Declaration (ACID) from initiation through benefit realization.
 </li>
 <li>
 Provide comprehensive functional leadership to the Digital Customer Solutions team, overseeing professional growth, resource planning, and knowledge continuity.
 </li>
 <li>
 Own the operational performance, service level agreements, and continuous enhancement of customer-facing shipping tools, including MyDHL+, APIs, Electronic Data Interchange (EDI), and breakbulk feeds.
 </li>
 <li>
 Act as the senior escalation point for technical customer support issues, managing critical operational problems to successful resolution.
 </li>
 <li>
 Partner with the Commercial division to streamline customer onboarding, training, and technical support on all corporate digital shipping applications.
 </li>
 <li>
 Drive technology automation and process improvement across internal IT workflows and external digital touchpoints to elevate service quality.
 </li>
 <li>
 Manage high-level stakeholder relationships across Operations, Commercial, Customer Service, Finance, Customs, Gateway, and external vendor partners.
 </li>
 <li>
 Represent Egypt IT in regional and global corporate forums, coordinating project dependencies and technical standards with international IT units.
 </li>
 <li>
 Maintain rigorous project governance, technical documentation, and performance reporting according to local and regional corporate standards.
 
 
 
 </li>
 </ul>
 
 Qualifications, Experience And Competencies
 
 
 
 
 <ul>
 <li>
 University Graduate with a Bachelor's degree in Information Technology, Computer Science, Engineering, or a closely related technical field.
 </li>
 <li>
 Project Management Professional (PMP) or PRINCE2 certification is highly desired.
 </li>
 <li>
 ITIL certification is considered a strong asset for service delivery alignment.
 </li>
 <li>
 6 to 8 years of proven experience in IT project/program management, systems solution delivery, or technical service management.
 </li>
 <li>
 2 to 3 years of experience in a formal team leadership or supervisory role, with a focus on coaching and developing technical personnel.
 </li>
 <li>
 Solid baseline knowledge of digital customer platforms, software application integration, APIs, and Electronic Data Interchange (EDI) protocols.
 </li>
 <li>
 Prior exposure to, or practical experience delivering software solutions for, trade compliance, logistics operations, or customs-related regulatory updates (e.g., Nafeza, ACID).
 </li>
 <li>
 Advanced analytical problem-solving skills combined with sound decision-making capabilities under demanding, non-negotiable external deadlines.
 </li>
 <li>
 Excellent communication, presentation, and stakeholder engagement skills, with the ability to influence senior business managers and external partners.
 </li>
 <li>
 Full professional proficiency in written and spoken English and Arabic.
 
 
 
 </li>
 </ul>
 
 Equal Treatment Clause:
 
 We are committed to fostering equal opportunity and strictly reject all forms of discrimination. At DHL Group, employee selection is based exclusively on individual qualification, performance, skills, and professional experience.
 
 
 ✨ We 𝗗𝗲𝗹𝗶𝘃𝗲𝗿 𝘁𝗵𝗲 𝗗𝗶𝗳𝗳𝗲𝗿𝗲𝗻𝗰𝗲
 
 
 ✨ We 𝗖𝗮𝗿𝗲
 
 
 ✨ We 𝗚𝗿𝗼𝘄 𝗧𝗼𝗴𝗲𝘁𝗵𝗲𝗿
</div>

IT Program Delivery Manager

Abu Dhabi Islamic Bank - Egypt

<div>
 
 
 Key Accountabilities:
 
 
 
 
 
 
 1.	Assist in improving the efficiency and effectiveness of the workflow.
 
 
 2.	Act as a checker and participate in team evaluation and provide feedback (if required).
 
 
 3.	Participate in reporting RSCA quarter sample.
 
 
 4.	Provide periodical analytical reports according to identified time.
 
 
 5.	Manage and ensure accurate, timely distribution of call data to support efficient task execution and decision-making.
 
 
 6.	Monitor team performance against KPIs, provide coaching, and collect feedback to identify challenges and drive improvements.
 
 
 7.	Support agents in:
 
 
 Tailoring their approach to different customer segments and share best practices for driving activation.
 
 
 Identifying upselling/cross selling opportunities and refining their sales approach.
 
 
 Identifying reactivation opportunities and refining their approach.
 
 
 8.	Track product uptake and share insights to improve team performance.
 
 
 9.	Identify customer feedback trends and escalate insights to direct manager for service improvement.
 
 
 10.	Identify recurring service issues and escalate them for resolution.
 
 
 11.	Collaborate with the internal stakeholders to align customer lifecycle management strategies with business objectives and regulatory requirements.
 
 
 12.	Oversee handling the related UAT testing and review the results to ensure correct implementation.
 
 
 13.	Ensure proper handling &amp; resolving complaints in cooperation with Consumer Rights Protection &ndash; Compliance &amp; Governance &ndash; in accordance with the policies and procedures and identified SLA.
 
 
 
 
 
 
 Qualifications &amp; Experience:
 
 
 
 
 
 
 &bull;	Bachelor&rsquo;s degree in Commerce, Business Administration, Accounting or its equivalence.
 
 
 &bull;	4 to 6 years of experience in sales or any related field of work, banking experience is a plus.
 
 
 
 
 
 
</div>

Customer Life Cycle Unit Team Leader

Red Bull

<div>
 The manager will be responsible for
 
 forecasting demand and planning supply
 
 to ensure product availability, optimize inventory levels, and align with the company&rsquo;s sales and financial goals. By working closely with Sales, Marketing, Finance, and other stakeholders, you will lead the
 
 Integrated Business Planning (IBP)
 
 process and drive collaboration across the supply chain.
 
 
 
 All the responsibilities we'll trust you with:
 
 
 
 
 Demand Planning:
 
 
 
 Analyze past sales and marketing trends to create accurate forecasts Work with Sales, Marketing, and Finance teams to finalize demand plans and ensure alignment Manage forecasts for products and Point-of-Sale materials (POSM), considering potential challenges and opportunities
 
 
 
 Supply Planning:
 
 
 
 Develop and execute supply plans to meet demand while optimizing inventory levels. Ensure consistent product availability, manage stock freshness, and plan for new product launches. Collaborate with logistics partners to ensure smooth operations from production to delivery
 
 
 
 S&amp;OP Leadership:
 
 
 
 Lead monthly Sales and Operations Planning (S&amp;OP) meetings with internal and external stakeholders. Align local supply plans with global strategies and address constraints.
 
 
 
 Inventory &amp; Distribution Management:
 
 
 
 Monitor distributor stock levels to prevent shortages or excess stock. Identify and address risks like slow-moving inventory or potential stock expiration. Manage the planning and deployment of coolers and POSM (200M EGP value in 2023).
 
 
 
 Reporting &amp; Insights:
 
 
 
 Track key supply chain performance metrics (e.g., forecast accuracy, inventory levels, and costs). Provide regular updates to leadership and distribution partners to improve operations and decision-making.
 
 
 
 Project Management:
 
 
 
 Lead new product launches and oversee supply chain projects to ensure timely delivery and market success. Work closely with external partners and regulatory authorities to meet market requirements.
 
 
 
 Your areas of knowledge and expertise that matter most for this role:
 
 
 
 <ul>
 <li>
 7-8+ years of experience in demand and supply planning, sales forecasting, and end-to-end supply chain operations.
 </li>
 <li>
 Strong analytical and problem-solving skills with expertise in data analysis and forecasting tools (e.g., SAP, IBP, Excel).
 </li>
 <li>
 Proven ability to collaborate across departments (Sales, Marketing, Finance) and manage stakeholders, including third-party logistics (3PL) and distribution partners.
 </li>
 <li>
 Excellent communication, negotiation, and organizational skills.
 </li>
 <li>
 Experience driving efficiency and leading change in supply chain processes.
 </li>
 <li>
 Bachelor&rsquo;s degree in Supply Chain, Business, or a related field (APICS certification is a plus).
 </li>
 </ul>
</div>

Supply & Demand Planning Manager

Explore 51+ Em regulatory affairs manager biosimilar in Cairo this August. Find roles across top companies and apply now to boost your career.