regulatory affairs manager

Revolut

<div>About Revolut
People deserve more from their money. More visibility, more control, and more freedom. Since 2015, Revolut has been on a mission to deliver just that. Our powerhouse of products &mdash; including spending, saving, investing, exchanging, travelling, and more &mdash; help our 70+ million customers get more from their money every day.
As we continue our lightning-fast growth,&zwnj; 2 things are essential to our success: our people and our culture. In recognition of our outstanding employee experience, we've been certified as a Great Place to Work&trade;. So far, we have 13,000+ people working around the world, from our offices and remotely, to help us achieve our mission. And we're looking for more brilliant people. People who love building great products, redefining success, and turning the complexity of a chaotic world into the simplicity of a beautiful solution.
About the role
The Regulatory Affairs team builds transparent relationships with regulators to keep Revolut moving forward with confidence. They stay ahead of regulatory change, provide timely responses to enquiries, and work across the business to ensure compliance is always in step with innovation.
We're looking for a Senior Regulatory Affairs Manager to manage regulatory engagement across the UAE.
You'll ensure our relationships with regulators are transparent by shaping the local regulatory engagement strategy, managing regulatory communications, and providing regulatory advice to leadership.
Up to shape what's next in finance? Let&rsquo;s get in touch.
What you&rsquo;ll be doing<ul><li>
Leading local regulatory engagement, ensuring interactions are transparent, professional, and consistent with Revolut&rsquo;s global standards</li><li>
Anticipating regulatory change and expectations, translating these into actionable strategies</li><li>
Ensuring regulatory commitments and remediation actions are tracked to completion</li><li>
Supporting the end-to-end management of regulatory inspections and audits</li><li>
Partnering with Product Owners and the Legal team to launch new features within the UAE's regulatory framework, and proactively engaging with regulators to test innovative solutions</li><li>
Preparing high-quality management information and briefing materials, ensuring regulatory matters are escalated when required</li><li>
Providing strategic regulatory advice and counsel to senior management and the group</li><li>
Building processes and documentation in a scalable and sustainable way</li><li>
Being a champion for conduct and compliance across the business</li></ul>
What you'll need<ul><li>
7+ years of experience in regulatory affairs, compliance, or risk management within a top-tier financial institution, fintech, or a regulatory body</li><li>
An existing professional network within the regulatory environment in the UAE</li><li>
Familiarity with key regulatory compliance regimes</li><li>
An understanding of the payments systems and markets with a focus on technology and mobile applications</li><li>
Excellent stakeholder management, communication, project management, and negotiation skills</li><li>
Knowledge of best practice in regional financial institutions regulations</li><li>
Problem-solving and decision-making skills to analyse complex information and identify the key issue/action to drive resolutions</li><li>
Experience coaching and inspiring people</li></ul>
Nice to have<ul><li>
A solid academic background from a top-tier university, including a degree in law, public policy, business administration, or finance</li><li>
An advanced qualification (LLB/LLM, CA, CS, CFA, etc.)</li></ul>
Building a global financial super app isn&rsquo;t enough. Our Revoluters are a priority, and that&rsquo;s why in 2021 we launched our inaugural D&amp;I Framework, designed to help us thrive and grow everyday. We're not just doing this because it's the right thing to do. We&rsquo;re doing it because we know that seeking out diverse talent and creating an inclusive workplace is the way to create exceptional, innovative products and services for our customers. That&rsquo;s why we encourage applications from people with diverse backgrounds and experiences to join this multicultural, hard-working team.
Important notice for candidates:
Job scams are on the rise. Please keep these guidelines in mind when applying for any open roles.<ul><li>Only apply through official Revolut channels. We don&rsquo;t use any third-party services or platforms for our recruitment.</li><li>Always double-check the emails you receive. Make sure all communications are being done through official Revolut emails, with an @revolut.com domain.</li></ul>
We won't ask for payment or personal financial information during the hiring process. If anyone does ask you for this, it&rsquo;s a scam. Report it immediately.
By submitting this application, I confirm that all the information given by me in this application for employment and any additional documents attached hereto are true to the best of my knowledge and that I have not wilfully suppressed any material fact. I confirm I have disclosed if applicable any previous employment with Revolut. I accept that if any of the information given by me in this application is in any way false or incorrect, my application may be rejected, any offer of employment may be withdrawn or my employment with Revolut may be terminated summarily or I may be dismissed. By submitting this application, I agree that my personal data will be processed in accordance with Revolut's Candidate Privacy Notice
Notice: This is a remote position based in United Arab Emirates.</div>

Regulatory Affairs Manager

EVA pharma

<div>
 
 Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.
 
 
 
 Job Summary
 
 
 
 We are seeking a detail-oriented and driven
 
 Regulatory Affairs Specialist
 
 to join our dynamic team.
 
 
 The&nbsp;ideal candidate will contribute to our mission of enhancing human health and well-being,&nbsp;ensuring that we meet the highest standards of excellence in our industry.
 
 
 
 
 Key Responsibilities:
 
 
 <ul>
 <li>
 Prepare and submit regulatory applications and documentation to the appropriate authorities within Europe
 </li>
 <li>
 Review and assess product labeling, promotional materials, and technical documentation for compliance with regulatory requirements
 </li>
 <li>
 Maintain knowledge of current and evolving regulations in the pharmaceutical sector, particularly within the European Union
 </li>
 <li>
 Act as the liaison between the company and regulatory authorities, facilitating communication and addressing inquiries or issues
 </li>
 <li>
 Support the development of regulatory strategies for new product registrations and life cycle management
 </li>
 
 
 </ul>
 
 Requirements
 
 
 
 <ul>
 <li>
 Bachelor's degree in Pharmacy, Life Sciences, or a related field
 </li>
 <li>
 1-3 years of experience in regulatory affairs within the pharmaceutical or healthcare industry
 </li>
 <li>
 Knowledge of EU regulatory frameworks, guidelines, and procedures
 </li>
 <li>
 Excellent communication skills, both written and verbal, in English; proficiency in additional European languages is a plus
 </li>
 <li>
 Highly organized with the ability to manage multiple projects and deadlines effectively
 </li>
 </ul>
</div>

Regulatory Affairs Specialist - Europe Cluster

Clark Associates

<div><h2 class="jobSectionHeader">Job Summary</h2>
The Senior Manager of Regulatory Affairs plays a critical leadership role in guiding and executing regulatory strategy across Clark Associates&rsquo; product portfolio. Reporting to the Director of Regulatory Affairs, this role is responsible for managing a regulatory team, navigating complex federal and state regulatory frameworks, and supporting process improvement as the team grows. 
 
This role requires deep experience working with U.S. regulatory bodies such as the FDA, FTC, EPA, and CPSC, as well as the judgment and communication skills needed to manage regulatory nuance, ambiguity, and competing business priorities. The ideal candidate brings both technical regulatory expertise and proven people leadership experience, with a strong preference for experience in sustainability and environmental regulations impacting plastics, paper, and disposable products.<h2 class="jobSectionHeader">
Responsibilities</h2><ul><li>
Lead, manage, and develop a team of regulatory professionals, providing coaching, prioritization, performance management, and professional growth support.</li><li>
Oversee regulatory strategy and execution across applicable federal, state, and local requirements, including but not limited to FDA, FTC, EPA, and CPSC obligations.</li><li>
Monitor, interpret, and assess new and emerging regulations, translating regulatory requirements into clear, actionable guidance for cross-functional business teams.</li><li>
Partner closely with Trade, Quality, Sourcing, Merchants and Legal to enable compliant product development, labeling, claims, and commercialization.</li><li>
Lead regulatory impact assessments for changes in law or guidance, including mitigation strategies and recommended business actions.</li><li>
Represent the company in interactions with regulatory agencies, trade associations, and external stakeholders as appropriate.</li><li>
Develop and maintain internal regulatory processes, guidance documents, and training materials to drive consistency and institutional knowledge.</li><li>
Support enterprise compliance initiatives, including audits, investigations, and response to regulatory inquiries.</li><li>
Prepare summaries, briefings, and recommendations to support leadership decision-making.</li><li>
Contribute to the continued development and maturity of the Regulatory Affairs function as the business scales.</li></ul><h2 class="jobSectionHeader">
Physical Requirements</h2><ul><li>
Work is performed while sitting/standing and interfacing with a personal computer.</li><li>
Requires the ability to communicate effectively using speech, vision, and hearing.</li><li>
Requires the regular use of hands for simple grasping and fine manipulations.</li><li>
Requires occasional bending, squatting, crawling, climbing, and reaching.</li><li>
Requires the ability to occasionally lift, carry, push, or pull medium weights, up to 50lbs.</li></ul><h2 class="jobSectionHeader">
Remote Work Qualifications</h2><ul><li>
Access to a reliable and secure high-speed internet connection. Cable or fiber internet connections (at least 75mbps download/10mbps upload) are preferred, as satellite connections often cannot support the technologies used to perform day-to-day tasks.</li><li>
Access to a home router and modem.</li><li>
A dedicated home office space that is noise- and distraction-free. The space should have strong wireless connection or a wired Ethernet connection (wired connection is preferred, if possible).</li><li>
A valid, physical address (apartment, suite, etc.). PO Boxes are not supported, as a physical address is required for you to receive your computer equipment.</li><li>
The desire and ability to work and communicate with other team members via chat, webcam, etc.</li><li>
Legal residents of one of the following states: (AK, AL, AR, AZ, CT, DE, FL, GA, IA, ID, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NM, NV, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WI, WV, or WY). H-1B Visa Sponsorship Not Available, W2 only.</li></ul><h2 class="jobSectionHeader">
Experience</h2><ul><li>
5+ years of experience managing people in a regulatory, compliance, or related function.</li><li>
Demonstrated experience navigating U.S. federal and state regulations, including interaction with agencies such as FDA, FTC, EPA, and CPSC.</li><li>
Experience evaluating and interpreting regulatory requirements across complex or evolving compliance landscapes.</li><li>
Preferred experience with sustainability, environmental, or materials-based regulations impacting plastics, paper, and disposable products.</li><li>
Proven ability to provide practical, business-focused regulatory guidance.</li></ul><h2 class="jobSectionHeader">
Education</h2>
This role does not require a degree. We value relevant skills and experience and alignment with our core values above all else.<h2 class="jobSectionHeader">
Desired Traits &amp; Skills</h2><ul><li>
Strong leadership presence with the ability to influence, mentor, and build high-performing teams.</li><li>
Comfortable navigating nuance, ambiguity, and competing regulatory interpretations.</li><li>
Excellent communication skills, with the ability to translate complex regulatory concepts into clear guidance for non-technical audiences.</li><li>
Highly organized, with the ability to manage multiple priorities in a fast-paced, evolving environment.</li><li>
Collaborative and solutions-oriented approach to cross-functional problem solving.</li><li>
High level of professionalism, discretion, and integrity when handling sensitive regulatory matters.</li></ul><h2 class="jobSectionHeader">
Company Overview</h2>
A rapidly growing, multi-divisional company headquartered in Lancaster, Pennsylvania with services supporting all of Clark&rsquo;s distribution methods in the food service industry.<h2 class="jobSectionHeader">
Benefits</h2><ul><li>
Medical</li><li>
Vision</li><li>
Dental</li><li>
PTO</li><li>
Paid Maternity Leave</li><li>
Paid Parental Leave</li><li>
Life Insurance</li><li>
Disability</li><li>
Dependent Care FSA</li><li>
401(k) matching</li><li>
Employee Assistance Program</li><li>
Wellness Incentives</li><li>
Company Discounts</li><li>
AT&amp;T &amp; Verizon Discount</li><li>
Bonus Opportunities</li><li>
Accident Insurance</li><li>
Critical Illness Insurance</li><li>
Adoption Assistance</li></ul><h3 class="jobSectionHeader">
Available at HQ Locations Only</h3><ul><li>
On-Site Fitness Centers</li><li>
Dog-friendly Offices</li></ul></div>

Senior Manager, Regulatory Affairs

Medichem Enterprises

Regulatory Affairs Officer &mdash; Job DescriptionLocation: Karachi Reports To: Regulatory Affairs ManagerRole OverviewResponsible for maintaining DRAP compliance, supporting regulatory submissions, and providing key documentation and technical support for tenders and commercial operations.Key Responsibilities<ul><li>Prepare &amp; submit DRAP product registration, renewals, variations, and import permissions, NOC's</li><li>Maintain regulatory documents: certificates, technical files, IFUs, CEO declarations, etc.</li><li>Support tender submissions by providing updated DRAP certificates, import history, and compliance forms</li><li>Coordinate regulatory requirements with principals/manufacturers</li><li>Support Sales &amp; Procurement with regulatory status for institutional approvals and import planning</li><li>Maintain compliance to GDP and assist in audits/inspections</li></ul>Qualifications<ul><li>Degree in Pharm-D / Biomedical / Life Sciences</li><li>1&ndash;3 years relevant experience preferred</li><li>Knowledge of DRAP &amp; Medical Devices Rules 2017</li></ul>Skills<ul><li>Strong documentation &amp; communication skills</li><li>Proficient in MS Office</li><li>Detail-oriented and organized</li></ul>Job Type: Full-timePay: Rs40,000.00 - Rs65,000.00 per monthWork Location: In person

Regulatory Affairs Officer

Amgen

<div>HOW MIGHT YOU DEFY IMAGINATION?
You&rsquo;ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Live
What you will do
Let&rsquo;s do this. Let&rsquo;s change the world. In this vital role, you will manage country-specific regulatory affairs for Amgen's molecules, coordinate and implement regulatory submissions, ensure compliance with corporate and local requirements and lead documentation for local submissions under Senior Manager's guidance :<ul><li>
Ensures regulatory submissions are made on time and meet Amgen&rsquo;s corporate and local regulatory requirements</li><li>
Local coordination and execution of regulatory submissions in compliance with corporate standards and local regulatory requirements.</li><li>
Execution of the preparation, delivery, and electronic archiving of documentation for inclusion in local regulatory submissions.</li><li>
Coordination and execution of Regulatory Affairs processes and deliverables in the local office.</li><li>
Reviews promotional and non-promotional materials</li><li>
Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner</li><li>
Partners with international Regulatory Leads (IRL) to support the regulatory development, registration, and lifecycle management of all Amgen molecules</li><li>
Partners with peers to ensure consistency on procedures</li><li>
Assists locally in Healthcare Compliance activities, where applicable</li><li>
Participate in local regulatory process improvements, initiatives, and training</li><li>
Overseas external vendor/contractor relationships, where applicable</li></ul>
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Associate Regulatory Affairs professional we seek is a teammate with these qualifications.
Basic Qualifications:<ul><li>
Bachelor`s degree in Pharmaceutical Science</li><li>
Knowledge of Regulatory Principles</li><li>
Working with policies, procedures and SOP&rsquo;s</li><li>
Comprehensive understanding of regulatory activities and how they impact other projects and/or processes</li><li>
Understanding of drug development</li><li>
Demonstrate ability to work in teams</li><li>
Ability to understand and communicate scientific/clinical information</li></ul>
Preferred Qualifications:<ul><li>
Regulatory experience of the Gulf Markets (1 year experience)</li><li>
Knowledge of legislation and regulations relating to medicinal products in the Gulf Markets.</li></ul>
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates&rsquo; professional and personal growth and well-being.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.</div>

Associate Regulatory Affairs - based in Egypt

Procter & Gamble

<div>Job Location
Riyadh
Job Description
Overview of the job
In this role, you will contribute to advancing P&amp;G Personal Healthcare&rsquo;s growth in the Kingdom of Saudi Arabia by leading regulatory strategies and supporting policy engagement to enable timely product approvals and sustainable market access. You will develop and execute Regulatory Affairs strategies across the product lifecycle from regulatory pathway assessment and submissions to approvals and compliance ensuring alignment with local regulatory requirements.
In parallel, you will support Policy Affairs efforts through engagement with regulatory authorities, government bodies, and industry associations to advocate for science-based policies and contribute to an enabling regulatory environment for innovation and patient access.
The role requires strong regulatory expertise, strategic thinking, and effective stakeholder management to navigate complex regulatory landscapes, ensure compliance, and support improved access for current and future P&amp;G PHC products in the Saudi market.
Your team
This role reports to Director of Research &amp; Development, Regulatory Affairs Middle East &amp; Africa &amp; will look after Saudi Arabia market
How Success Looks Like<ul><li>
You understand regulatory requirements deeply and apply them effectively to ensure compliance for Saudi Arabia market.</li><li>
You develop and implement regulatory strategies that streamline product submissions and registrations, resulting in timely market access.</li><li>
You build and maintain strong relationships with regulatory authorities, leveraging these connections to partnership for faster route to market.</li><li>
You lead and execute training programs for the regulatory team and other departments, ensuring they are informed and up to date on regulatory requirements and best practices.</li><li>
You provide strategic guidance and support to cross-functional teams, ensuring regulatory considerations are integrated into product development and business processes.</li><li>
Designs or sources health economic projects to optimize messaging and favourable perception/adoption of products/technologies/procedures as required.</li><li>
You proactively identify potential regulatory risks and develop strategies to ensure continuous compliance and business continuity.</li><li>
You effectively manage and mentor teams, fostering a culture of excellence, collaboration, and professional growth within the regulatory affairs function.</li></ul>
Responsibilities of the role<ul><li>
Lead and coordinate day-to-day Regulatory Affairs activities for assigned products and initiatives, ensuring alignment with regional and global regulatory strategies.</li><li>
Monitor and assess the evolving regulatory landscape across Saudi Arabia, providing strategic insights on regulatory changes and their impact on business operations and product registrations.</li><li>
Ensure compliance with global, regional, and local regulatory requirements by implementing and maintaining appropriate processes, policies, SOPs, and working instructions.</li><li>
Manage the preparation, compilation, and submission of regulatory dossiers, including responses to health authority queries and regulatory correspondence in accordance with applicable guidelines and country-specific requirements.</li><li>
Collaborate cross-functionally with R&amp;D, Commercial, Quality, Supply Chain, and Legal teams to support regulatory strategies that enable efficient product approvals and lifecycle management.</li><li>
Build and maintain effective relationships with regulatory authorities and relevant external stakeholders to support transparent communication and facilitate regulatory processes.</li><li>
Support the development and execution of Public Policy and advocacy initiatives by engaging with industry associations, government entities, and regulatory bodies to promote science-based, predictable, and innovation-friendly regulatory frameworks.</li><li>
Contribute to shaping policy positions and industry proposals that support improved regulatory pathways, market access, and patient access to healthcare products.</li></ul>
Core Regulatory &amp; Policy Practices:<ul><li>
To prepare &amp; submit registration dossiers and to achieve registration for the specific product portfolio, within agreed timelines.</li><li>
To update and maintain dossiers post registration, to ensure compliance with corporate and health authority legal requirements. This will include the submission of variation documents.</li><li>
To ensure the renewal of registration of products by defining the accurate timelines.</li><li>
To ensure maintenance and update of regulatory files and records including appropriate archiving of all relevant documentation in appropriate system in line with applicable internal company standards</li><li>
To review and ensure the conformity of the product artworks, promotional material and tools with the marketing code and legal requirements.</li><li>
To Liaise with health authorities, distributors, regulatory authorities, and trade associations to achieve and maintain registrations.</li><li>
To develop relationships with regulatory bodies to represent the interests of the organization, gain relevant information and help shape change.</li><li>
Leads, monitors, assesses, and communicates risks on key projects, providing regular updates to Stakeholders and Senior Management</li><li>
Monitors and progress of applications against set timelines, acting where necessary, to minimize delays and anticipate difficulties/challenges.</li><li>
Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested.</li><li>
Affect legislative and executive public policy outcomes by educating, persuading, and negotiating with policy makers; creating political allies; building coalitions; and utilizing the P&amp;G Government Relations resources, policies, and expertise to achieve the company&rsquo;s political and business objectives.</li><li>
Monitor legislative developments and identify emerging issues to the company, and in coordination with management and global government relations and public policy function; develop company positions and priorities on public policy issues which impact P&amp;G&rsquo;s business and position.</li></ul>
Role Requirements
Qualifications &amp; technical skills<ul><li>
Saudi Licensed Pharmacist from Saudi commission for health specialities</li><li>
Years of Experience: 5 Years or more in Pharmaceutical/ Personal Healthcare Regulatory Experience</li><li>
Language: English and Arabic Fluency.</li><li>
Location: Riyadh KSA</li></ul>
Soft skills<ul><li>
Proven ability to effectively negotiate with SFDA on technical and policy matters to drive optimal outcomes.</li><li>
Experience from a multi-national or regional company is required.</li><li>
Experience in Pharma &amp; Consumer Personal Healthcare products</li><li>
Excellent Oral &amp; written communication skills, interpersonal, and influencing skills.</li><li>
Effective communications with different audiences.</li><li>
Negotiations, Coalition, and effective lobbying skills.</li><li>
Team activity, collaborative individual and must have the ability to establish relationships across departments to handle and deliver departmental result</li></ul>
About us
We produce globally recognized brands and we grow the best business leaders in the industry. With a portfolio of trusted brands as diverse as ours, it is paramount our leaders are able to lead with courage the vast array of brands, categories and functions. We serve consumers around the world with one of the strongest portfolios of trusted, quality, leadership brands, including Always&reg;, Ariel&reg;, Gillette&reg;, Head &amp; Shoulders&reg;, Herbal Essences&reg;, Oral-B&reg;, Pampers&reg;, Pantene&reg;, Tampax&reg; and more. Our community includes operations in approximately 70 countries worldwide.
Visit http://www.pg.com to know more.
We are an equal opportunity employer and value diversity at our company. We do not discriminate against individuals on the basis of race, color, gender, age, national origin, religion, sexual orientation, gender identity or expression, marital status, citizenship, disability, HIV/AIDS status, or any other legally protected factor.
Job Qualifications<ul><li>
Saudi Licensed Pharmacist from Saudi commission for health specialities</li><li>
Years of Experience: 5 Years or more in Pharmaceutical/ Personal Healthcare Regulatory Experience</li><li>
Language: English and Arabic Fluency.</li><li>
Location: Riyadh KSA</li></ul>
Job Schedule
Full time
Job Number
R000147983
Job Segmentation
Experienced Professionals</div>

Senior Manager - Regulatory & Policy Affairs

<div>
 HOW MIGHT YOU DEFY IMAGINATION?
 
 
 <ul>
 <li>
 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.
 
 
 </li>
 </ul>
 Job purpose:
 
 
 <ul>
 <li>
 As a member of this fast-pace, complex and dynamic region, MEA Regulatory Affairs Senior Associate will be accountable for labeling and packaging activities management for Middle East North African region for Amgen portfolio for pipeline, inline and biosimilars; as well participating in labeling projects internally and externally for e-labeling implementation; and execution of Regulatory Affairs processes in the local office.
 
 
 </li>
 </ul>
 Job Responsibilities:
 
 
 <ul>
 <li>
 Deliver both strategic and administrative system support for ongoing maintenance with Lifecyle management and updates to our existing platforms and systems, to ensure data standards are 100% accurate, as to enable effective reporting and data analytics
 </li>
 <li>
 Manage Performance Excellence through collection, analyzing &amp; disseminating relevant information to team(s) as appropriate
 </li>
 <li>
 Participate in local regulatory process improvements initiatives
 </li>
 <li>
 Build newsletter, annual Report, data analysis with follow up on Key Performance Indicators and Metrics
 </li>
 <li>
 Ensure delivery of right first time label source text for artwork creation
 </li>
 <li>
 Support efficiently the filing plan of different marketing application submissions and products life cycle management filings by providing regional product information (leaflet and SmPC) source texts and artworks in a timely manner
 </li>
 <li>
 Ensure implementation of master artworks as per Amgen procedures, SKU strategy and timelines with high quality to serve our patients in MENA region
 </li>
 <li>
 Access the translation agency systems to request the label translation and track the job readiness and timelines.
 </li>
 <li>
 Perform regional prescribing information translation review: 100% review of both content and format
 </li>
 <li>
 Perform the role of source text owner/approver and artwork reviewer/approver in the system
 </li>
 <li>
 Trigger the existing label revision when alerted by global RA team.
 </li>
 <li>
 Support in product launch and ensure supply continuity by creating and revising the commercial pack artworks (leaflet, label, blister, outer pack)
 </li>
 <li>
 Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.
 
 
 </li>
 </ul>
 Qualifications:
 
 
 <ul>
 <li>
 Experience +2 years in Regulatory Affairs
 </li>
 <li>
 Current/ previous experience in working as part of an MNC employer
 </li>
 <li>
 Pharmacist, biologist, chemist-medical background
 </li>
 <li>
 Fluent in English and Arabic for translation review purpose ( French is a huge plus)
 </li>
 <li>
 A minimum knowledge of Middle East Africa regulatory requirements
 </li>
 <li>
 Strong communication skills (verbal &amp; written) with ability to understand and communicate the scientific information and anticipate/prevent potential issues
 </li>
 <li>
 Conflict Management skillset &amp; ability to deal with multiple stakeholders simultaneously.
 
 
 </li>
 </ul>
 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>
 <li>
 Vast opportunities to learn and move up and across our global organization
 </li>
 <li>
 Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
 </li>
 <li>
 Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
 
 
 </li>
 </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.
 
 
 We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
</div>

MEA Regulatory Affairs Senior Associate

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