regulatory affairs manager

Delta Pharma

<div>
 
 
 📌 Key Responsibilities:
 
 
 
 
 
 <ul>
 <li>
 Develop and execute regulatory strategies aligned with
 
 Egyptian regulations for human and veterinary products
 
 .
 </li>
 <li>
 Lead preparation, review, and submission of
 
 CTD dossiers
 
 to the Egyptian Drug Authority.
 </li>
 <li>
 Manage full lifecycle activities including
 
 new registrations, variations, renewals, and re-registration
 
 for both sectors.
 </li>
 <li>
 Act as the primary contact with EDA departments handling
 
 human and veterinary dossiers
 
 .
 </li>
 <li>
 Ensure compliance with all
 
 local laws, decrees, and veterinary-specific regulatory requirements
 
 .
 </li>
 <li>
 Oversee
 
 pilot batch production, stability studies, and bio/clinical or veterinary-specific data requirements
 
 .
 </li>
 <li>
 Coordinate with internal teams (R&amp;D, Quality, Production, Supply Chain) to ensure regulatory alignment.
 </li>
 <li>
 Monitor regulatory updates in Egypt and assess impact on both human and veterinary portfolios.
 </li>
 <li>
 Manage timelines, regulatory risks, and mitigation strategies to ensure timely approvals.
 </li>
 <li>
 Support regulatory inspections and ensure audit readiness.
 </li>
 <li>
 Lead, mentor, and develop regulatory team members.
 </li>
 </ul>
 
 
 
 
 
 📌 Qualifications:
 
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Pharmacy.
 </li>
 <li>
 
 13+ years of experience in Regulatory Affairs within Egypt
 
 , covering
 
 both human and veterinary products
 
 .
 </li>
 <li>
 Strong hands-on experience with
 
 EDA systems, submissions, and regulatory pathways
 
 .
 </li>
 <li>
 In-depth knowledge of
 
 CTD structure, lifecycle management, and veterinary regulatory requirements in Egypt
 
 .
 </li>
 <li>
 Proven success in obtaining approvals for both
 
 pharmaceutical and veterinary products
 
 .
 </li>
 <li>
 Excellent leadership, communication, and stakeholder management skills.
 </li>
 </ul>
 
 
 
 
 
 📌 Preferred Skills:
 
 
 
 
 
 <ul>
 <li>
 Strong understanding of
 
 EDA platforms
 
 </li>
 <li>
 Strategic regulatory planning across multiple product categories
 </li>
 <li>
 Advanced project management and risk assessment
 </li>
 <li>
 Strong negotiation and authority interaction skills
 </li>
 <li>
 High attention to detail and compliance-driven mindset
 </li>
 </ul>
 
 
</div>

Regulatory Affairs Manager

Astellas Pharma

<div>
 
 Description
 
 
 
 
 Regulatory Affairs Manager - Levant
 
 
 
 
 About Astellas
 
 
 
 Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com
 
 
 
 Are you driven to make a real difference in the lives of patients?
 
 
 
 We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
 
 
 
 Location and Working Environment
 
 
 
 This position is hybrid and will require you to be onsite 2 days per week/month/quarter in ISTANBUL, TURKEY office
 
 
 Astellas&rsquo; Responsible Flexibility Guidelines Statement- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas&rsquo; Responsible Flexibility Guidelines.
 
 
 
 Purpose &amp; Scope
 
 
 
 <ul>
 <li>
 As the Regulatory Affairs Manager - Levant, you will be reporting directly to the Sub-Regional Lead, Turkey Middle East Africa (TMEA) and be responsible to arrange the provision of regulatory expertise and execution of regulatory strategy &amp; activities for new Marketing Authorizations (MAs) and Life Cycle Management of MAs in the territory.
 </li>
 <li>
 This is an individual contributor position, full time, permanent position.
 
 
 </li>
 </ul>
 
 Role And Responsibilities
 
 
 
 <ul>
 <li>
 Develop national regulatory submission strategy and planning for new MAA and Life Cycle management activities. Advise on optimal regulatory pathway &amp; timelines, dossier content including CMC, Clinical and labelling, EAP/CDx.
 </li>
 <li>
 Initiate, review and approve Product information (SmPC/aPI/PIL/aRMM) &amp; artworks
 </li>
 <li>
 Ensure timely preparation, submission to the HA and follow up of regulatory applications including preparation of regional/local specific documents and other tasks (eg translations).
 </li>
 <li>
 Ensure regulatory compliance &amp; reputation. Develop and maintain professional relationships with relevant external contacts including the Health Authority and Trade Associations
 </li>
 <li>
 Review/approve promotional materials with an in-depth understanding of code
 
 
 </li>
 </ul>
 
 Required Qualifications
 
 
 
 <ul>
 <li>
 Substantial experience within a similar Regulatory Affairs role ideally with a global pharma organization.
 </li>
 <li>
 Experience working with distributor markets &amp; business partners across the Levant and Gulf region would be highly preferred.
 </li>
 <li>
 Knowledge of Regulatory landscape and procedures within the country/region
 </li>
 <li>
 Knowledge of the Regulatory compliance
 </li>
 <li>
 Strong communication skills with the ability to work through change management
 </li>
 <li>
 BA/BS Degree in Pharmacy, Medical or other Life Science, or equivalent
 
 
 </li>
 </ul>
 
 Preferred Qualifications
 
 
 
 <ul>
 <li>
 Good communication, influential, planning and problem-solving skills, along with the ability to build and manage close relationships with all relevant stakeholders.
 
 
 </li>
 </ul>
 
 What awaits you at Astellas?
 
 
 
 <ul>
 <li>
 Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
 </li>
 <li>
 Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
 </li>
 <li>
 Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
 </li>
 <li>
 A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
 
 
 </li>
 </ul>
 
 Our Organizational Values and Behaviors
 
 
 
 <ul>
 <li>
 Impact
 </li>
 <li>
 Innovation
 </li>
 <li>
 Integrity
 </li>
 <li>
 One Astellas
 </li>
 <li>
 Accountability
 </li>
 <li>
 Courage
 </li>
 <li>
 Sense of Urgency
 </li>
 <li>
 Outcome Focus
 
 
 </li>
 </ul>
 
 Benefits
 
 
 
 Careers | Astellas
 
 
 We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
 
 
 Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
 
 
 # LI-Istanbul
 
 
</div>

Regulatory Affairs Manager - Levant

Amgen

<div><div>Egypt - Cairo
<div>JOB ID: R-243855 LOCATION: Egypt - Cairo WORK LOCATION TYPE: Flex Commuter / Hybrid DATE POSTED: Apr. 28, 2026 CATEGORY: Regulatory
</div></div><div><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>
Regulatory Affairs Manager| ELI
Job Responsibilities:<ul><li>
High-quality and timely Regulatory Affairs input to planned filings and approvals of new marketing authorizations (MA) and line-extensions.</li><li>
Maintain established products according to global and local regulatory plans.</li><li>
Update and maintain regulatory databases.</li><li>
Handle Health Authorities requests.</li><li>
Build and keep a highly professional relationship with the Medicines Agency.</li><li>
Support and interact with global regulatory affairs, QA, Market Access, Marketing (projects and product teams) and Sales to best support local and global strategy.</li><li>
Monitor future trends in regulatory affairs which are likely to affect AMGEN interest.</li><li>
Perform or facilitate audits to ensure compliance</li></ul>
Qualifications:
<ul><li>A bachelor&rsquo;s degree in Pharmacy or any relevant field.</li><li>
Minimum of 6 years of regulatory experience in the pharmaceutical industry or with Health Authorities.</li><li>
Excellent current regulatory knowledge understanding of US FDA and EMEA regulatory guidelines.</li><li>
Advanced ability to interpret scientific data and to construct persuasive regulatory documents.</li><li>
Good communication skills, ability to work effectively in a matrix setup.</li><li>
Strong knowledge of regulatory life cycle maintenance.</li><li>
Having People Management experience is critical.</li><li>
An analytical approach balanced with a keen eye for detail demonstrated in all document control and administration undertaken.
</li><li>Strong communication and leadership skills with the ability to select, motivate, train, and develop staff to achieve company goals.</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>
 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></div></div>

Regulatory Affairs Manager| ELI

TAQWA PHARMA

Job Opportunity: Regulatory Affairs ManagerWe are looking for a dynamic and self-driven Regulatory Affairs Manager to spearhead our documentation and compliance department. We need a proactive professional with a sharp eye for detail who can take full ownership of our international dossier pipeline and drive high-stakes projects to completion.Key Responsibilities<ul><li>Dossier Mastery: Lead the end-to-end preparation, compilation, and technical checking of ASEAN Common Technical Dossiers (ACTD).</li><li>Export Compliance: Oversee and verify HOTC export dossiers to ensure seamless international submissions and approvals.</li><li>Quality Leadership: Act as the final authority on technical accuracy, ensuring all documentation is 100% compliant with global Ministry of Health standards.</li><li>Strategic Workflow: Manage timelines with high energy, ensuring that registration goals for international markets are met efficiently.</li></ul>Required Qualifications<ul><li>Experience: Minimum of 5 years of proven experience in Pharmaceutical Regulatory Affairs.</li><li>Technical Expertise: Specialized knowledge in ACTD formats and international export documentation.</li><li>Education: B.Pharm, Pharm.D, or a relevant Master&rsquo;s degree.</li><li>Core Attributes: We are seeking a young and energetic individual who is career-oriented and capable of working with minimal supervision.</li></ul>Compensation &amp; Benefits<ul><li>Salary: Market-competitive salary package based on experience and technical expertise.</li><li>Growth: Opportunities for professional development in a growing international business environment.</li></ul>Job Details<ul><li>Location: Karachi (Office conveniently located near the Karachi Chamber of Commerce and Industry).</li><li>Gender: Open to both Male and Female candidates.</li><li>Type: Full-time.</li></ul>Experience:<ul><li>regulatory manager: 4 years (Required)</li></ul>Work Location: In person

Regulatory Manager - Pharmaceutical

Anekor Pakistan

We are urgently looking for a Manager &ndash; Government Affairs for one of our clients in the manufacturing industry, based in Islamabad.Requirements:<ul><li>Bachelor&rsquo;s or Master&rsquo;s degree in a related field</li><li>5&ndash;8 years of experience in Government Affairs / Regulatory Affairs (manufacturing sector preferred)</li><li>Strong communication, negotiation, and stakeholder management skills</li><li>Good understanding of local laws, policies, and compliance frameworks</li></ul>Location: IslamabadInterested candidates can apply at: prinka.kumari@anekorpakistan.comCC: heena@anekorpakistan.com#Hiring #GovernmentAffairs #PublicAffairs #ManufacturingJobs #IslamabadJobs #RegulatoryAffairsJob Type: Full-timeWork Location: In person

Manager – Government Affairs

anekor

We are urgently hiring a Manager &ndash; Government Affairs for one of our clients in the manufacturing industry, based in Islamabad.Responsibilities<ul><li>Develop and maintain strong relationships with government departments and regulatory authorities</li><li>Ensure compliance with applicable laws, regulations, and government policies</li><li>Liaise with government bodies for approvals, licenses, permits, and documentation</li><li>Monitor policy and regulatory changes and assess their impact on business operations</li><li>Represent the organization in official meetings, forums, and engagements</li><li>Coordinate with internal departments for regulatory alignment and compliance</li><li>Manage government-related correspondence, reporting, and documentation</li><li>Support senior management in handling regulatory and strategic government matters</li></ul>Requirements<ul><li>Bachelor&rsquo;s or Master&rsquo;s degree in Public Administration, Political Science, Law, or a related field</li><li>5&ndash;8 years of experience in government affairs, regulatory affairs, or a similar role (manufacturing industry preferred)</li><li>Strong network with government and regulatory authorities</li><li>Excellent communication, negotiation, and interpersonal skills</li><li>Strong understanding of local laws, policies, and compliance frameworks</li><li>Ability to handle sensitive and confidential matters professionally</li></ul>Salary: 400K To 500K+ BenefitsLocation: IslamabadWork Location: In person

Manager Government Affairs

<div><div>Egypt - Cairo
<div>JOB ID: R-241891 LOCATION: Egypt - Cairo WORK LOCATION TYPE: Flex Commuter / Hybrid DATE POSTED: Apr. 08, 2026 CATEGORY: Regulatory
</div></div><div><div><h2 class="jobSectionHeader">HOW MIGHT YOU DEFY IMAGINATION?</h2><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 achievetogether&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><h2 class="jobSectionHeader">
Job purpose:</h2><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><h2 class="jobSectionHeader">
Job Responsibilities:</h2><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><h2 class="jobSectionHeader">
Qualifications:</h2><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><h2 class="jobSectionHeader">
 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.</h2></div></div></div>

MEA Regulatory Affairs Senior Associate

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