manager of regulatory affairs

Danone

<div>About the job

Danone MENA is looking for a six months Temporary Regulatory Affairs Manager to be based in Cairo, Egypt like you!

In the context of Specialized Nutrition MENA, you will be responsible to drive and contribute to SN brand market share in the assigned area, build productive scientific-based HCP relationships, taking responsibility for HCP satisfaction and loyalty by meeting their health care nutrition needs. 

Key Responsibilities:
<ul><li>Assist in developing and implementing public affairs strategies and campaigns to support the organization's objectives.</li></ul>
<ul><li>Support in engagements with key stakeholders, including government officials, industry associations, and community groups.</li></ul>
<ul><li>Prepare and Review Registration &amp; Variation files for countries within the MENA Region</li></ul>
<ul><li>Follow-Up with the Distributor and Authorities on the status of our submitted dossiers</li></ul>
<ul><li>Participate in the strategic regulatory planning meetings</li></ul>
<ul><li>Prepare briefings, presentations, and written materials for internal and external audiences.</li></ul>
<ul><li>Assist in organizing events, such as roundtables, briefings, and conferences, to engage with stakeholders and promote the organization's interests.</li></ul>
<ul><li>Contribute to the development of advocacy materials, including position papers, submissions to government consultations, and letters to policymakers.</li></ul>
<ul><li>Coordinate with the Communications team to ensure consistent messaging across public affairs and media activities.</li></ul> 

About you

Qualifications:
<ul><li>Bachelor's degree in Science, or a related field.</li></ul>
<ul><li>1-2 years of experience in Regulatory, public affairs, government relations, or a similar role.</li></ul>
<ul><li>Strong understanding of the political and legislative process within MENA.</li></ul>
<ul><li>Excellent verbal and written communication skills Arabic&amp; English</li></ul>
<ul><li>Ability to analyze complex policy issues and develop clear, persuasive arguments.</li></ul>
<ul><li>Strong organizational skills and the ability to manage multiple projects simultaneously.</li></ul>
<ul><li>Team player with the ability to work collaboratively in a fast-paced environment.</li></ul>
<ul><li>Proficiency in Microsoft Office</li></ul>

Personal Attributes:
<ul><li>Strong interpersonal skills with the ability to build and maintain relationships.</li></ul>
<ul><li>High level of initiative and self-motivation.</li></ul>
<ul><li>Attention to detail and accuracy.</li></ul>
<ul><li>Adaptability and flexibility to respond to changing priorities and issues</li></ul>
About us

Danone is a world-leading food company operating in three business divisions: Fresh Dairy Products, Specialized Nutrition, and Waters. 
Danone&rsquo;s mission is Bringing health through food to as many people as possible and we want to invite people to join the movement for a healthier world. We recognize the power people have in impacting the world through their daily choices. Each time we eat and drink, we vote for the world we want to live in. We believe a healthy body needs healthy food. And healthy food needs a healthy planet and this is what our new signature One Planet One Health embodies.

#LI-ME

#LI-EG</div>

Regulatory Affairs Manager – Temporary 6-Months Contract

Omantel

<div>
 
 Role Purpose
 
 
 
 Ensuring a conducive regulatory environment for Omantel's business through proactive coordination and management of data collection, dissemination of reports, and diligent follow-up on regulatory matters
 
 
 
 Position Information
 
 
 
 
 Title: Senior Manager Regulatory Affairs
 
 
 
 <ul>
 <li>
 Unit: Governance, Regulatory &amp; Compliance
 </li>
 <li>
 Division: Regulatory &amp; Legal
 </li>
 <li>
 Location:
 </li>
 <li>
 Grade: L2
 </li>
 <li>
 Line Manager: General Manager Regulatory &amp; Legal
 </li>
 <li>
 Minimum role requirements:
 </li>
 <li>
 Bachelor in relevant discipline
 </li>
 <li>
 Internal Applicants: 6 years of relevant experience with at least 3 years in a management position
 </li>
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 External Applicants: 10 years of relevant experience with at least 3 years in a management position
 
 
 </li>
 </ul>
 
 Key Accountabilities
 
 
 
 <ul>
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 Ensure consistency, completeness, and adherence to standards for all regulatory submissions
 </li>
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 Liaise with the TRA to facilityate regulatory submissions, responding to queries, and ensure timely approvals
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 Develop, implement, review and manage a compliance monitoring programme
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 Manage dissemination of all regulatory circulars, communication, analysis and studies conducted by the TRA
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 Manage and ensure the accuracy and timely submission of regulatory reports
 </li>
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 Evaluate regulatory resource requirements, including but not limited to numbering requests to the TRA (Normal Numbers, Short Codes, Toll-Free Numbers, SPSs, and SMS Short Codes)
 </li>
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 Coordinate with relevant departments on issues related to radio licenses, new/renewal for Microwave, Vsat and WLL systems, Paging system, RRT, GMS 900, GSM 1800, etc
 
 
 </li>
 </ul>
 
 Key Competencies
 
 
 
 
 Leadership
 
 
 
 <ul>
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 Assertiveness and Conflict Resolution
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 Fostering Learning and Development
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 Inspiring and Leading Others
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 Leading Change and Cultivates Innovation
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 Visioning and Alignment
 
 
 </li>
 </ul>
 
 Behavioural
 
 
 
 <ul>
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 Drives Achievements
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 Ethics &amp; Compliance
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 <li>
 Timely Decision - Making
 
 
 </li>
 </ul>
 
 Technical
 
 
 
 <ul>
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 Regulatory Strategy &amp; Liaison
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 Regulatory Strategy Planning and Implementation
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 </ul>
</div>

Senior Manager Regulatory Affairs

Gilead Sciences

<div>
 At Gilead, we&rsquo;re creating a healthier world for all people. For more than 35 years, we&rsquo;ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer &ndash; working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world&rsquo;s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 
 
 Every member of Gilead&rsquo;s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we&rsquo;re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 
 
 We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
 
 
 
 Job Description
 
 
 
 Regulatory Affairs Manager Turkiye; is responsible from managing RA submissions &amp; supporting Clinical Trials applications and will serve as a core member of the affiliate Regulatory Team interacting with local Regulatory Authorities and other stakeholders to ensure that the company complies with country&rsquo;s applicable legislations.
 
 
 
 Knowledge &amp; Details
 
 
 
 <ul>
 <li>
 Manage regulatory submissions to local HA submissions inc. but not limited to Pre-MAA related activities (GMP &amp; prioritization applications), marketing Authorisation (MA) applications &amp; variations and other MA maintenance applications, in line with local HA expectations, Gilead SOPs and business objectives for assigned product(s) or projects.
 </li>
 <li>
 Stay up to date with local and global regulatory requirements (including ICH), internal policies and support the organization in adapting to legislative changes.
 </li>
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 Responsible from ensuring the updates to commercial product packaging and labelling in line with product licenses.
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 Manage clinical trial applications, amendments, and notifications. Collaborate with Clinical Operations and the CT Hub to complete CT submissions to MOH timely and interacts with cross-functional teams internally and externally to ensure submission package fulfils the MoH requirements on time.
 </li>
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 Ensure ongoing clinical trials comply with local legislation and oversee investigational product packaging and labelling approvals.
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 Plan regulatory and clinical timelines and strategies under the guidance of the Regulatory Affairs Director.
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 Ensure good and strong relationships with functional areas of the local organization (Medical Affairs, Commercial, Market Access, Legal, etc.) and with Gilead Sciences Global/Regional RA in order to ensure the success of local and international business results from the regulatory point of view.
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 Build and maintain networks with regulatory stakeholders, including decision-makers and influencers.
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 Develop and implement regulatory and clinical trial strategies, and manage negotiations with health authorities.
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 Actively contribute to local and global initiatives that improve regulatory processes.
 
 
 </li>
 </ul>
 
 Professional Experience / Key Skills
 
 
 
 <ul>
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 Solid experience in total in Regulatory Affairs &amp; Clinical Trials (if possible) related experience in the Pharmaceutical / Biotech Industry. An advanced degree is desirable.
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 Degree in Pharmaceutical Sciences or equivalent discipline is preferred.
 </li>
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 Proven ability to prioritize, conduct, and manage time to meet project deadlines.
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 Good influencing and negotiating skills. Must be capable of developing and implementing regulatory initiatives and managing negotiations with Regulatory Authorities.
 </li>
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 Demonstrates leadership skills with a sphere of influence externally, cross-functionally and within the RA and the affiliate.
 </li>
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 Strong focus on achievement of goals and continuous improvement
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 Solution-oriented and innovative; can identify creative options for resolving issues that respond to multiple stakeholder interests and needs.
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 Having excellence in multiple project management, good communication and interpersonal skills.
 </li>
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 Be an analytical thinker, problem solver, proactive, initiative taker, creative personality
 </li>
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 Team player who actively contributes to the team in order to complete tasks, meet goals or manage projects, actively listen others, respect ideas and aim to improve the process.
 </li>
 <li>
 Fluency in spoken and written English.
 </li>
 <li>
 Good decision-making skills are important.
 </li>
 <li>
 Excellent verbal, written, organization skills and interpersonal communication skills required.
 
 
 </li>
 </ul>
 Equal Employment Opportunity (EEO)
 
 
 It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual&rsquo;s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
 
 
 
 For Current Gilead Employees And Contractors
 
 
 
 Please apply via the Internal Career Opportunities portal in Workday.
</div>

Regulatory Affairs Manager

Qiddiya Investment Company

<div>Qiddiya is Saudi Arabia&rsquo;s future capital of entertainment, sports, and culture &mdash; a 360 km&sup2; mega-project just outside Riyadh. From F1-grade racetracks and theme parks to stadiums and performance venues, we&rsquo;re creating a destination like no other. This is more than a project, it&rsquo;s a national transformation. As construction accelerates, we&rsquo;re hiring ambitious talent to help shape it. If you&rsquo;re driven by scale, impact, and the chance to build something iconic from the ground up, Qiddiya is calling for you.
General Summary:
The Regulatory &amp; Policy team within the Transport Business Unit (TBU) plays a vital role in shaping the transport agenda at Qiddiya by ensuring alignment with national regulatory frameworks, policy environments, and sector-specific mandates. The team leads on regulatory submissions, inter-governmental engagement, policy impact assessments, and supports the TBU&rsquo;s compliance with external approvals and governance protocols. Working cross-functionally, the team serves as the BU&rsquo;s interface with external regulators, government bodies, and internal delivery stakeholders.
The Senior Manager supports the execution of the TBU&rsquo;s regulatory roadmap, manages key relationships with government agencies, and leads the preparation of critical regulatory submissions and position papers. The role ensures that regulatory timelines are met and that Qiddiya&rsquo;s interests are well-represented in external engagements.
Essential Duties and Responsibilities:<ul>
<li>
Support the Associate Director in managing approvals and permits from regulatory authorities.</li>
<li>Coordinate development of regulatory documents and responses to government inquiries.</li>
<li>Track and report on regulatory changes impacting transport projects.</li>
<li>Build working relationships with government officials and regulatory entities.</li>
<li>Support internal project teams with regulatory guidance and interface planning.</li>
</ul>
Requirements
Qualifications:<ul><li>
Bachelor&rsquo;s degree in Public Policy, Law, Political Science, Transport Planning, or related discipline.</li></ul>
Years of Experience:<ul><li>
8+ years in regulatory affairs, permitting, or policy advisory in a transport or infrastructure setting.</li></ul></div>

Senior Manager - Regulatory and Policy (CDU3) - CDUP 2064

Amgen

Associate Regulatory Affairs - based in Dubai Join to apply for the Associate Regulatory Affairs - based in Dubai role at Amgen.You'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-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. What You Will Do Let's do this. Let'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's corporate and local regulatory requirements</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 (IRLs) and Global Regulatory Leads (GRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.</li><li>Partners with peers to ensure consistency on procedures.</li></ul> What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The Regulatory Affairs professional we seek is a teammate with these qualifications. Basic Qualifications <ul><li>Bachelor's degree in Pharmaceutical Science</li><li>Working with policies, procedures and SOPs.</li><li>Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.</li><li>Knowledge of the Gulf legislation and regulations.</li><li>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.</li><li>Knowledge of regional countries legislation and regulations relating to medicinal products in the Gulf Markets.</li><li>Experience interacting with regulatory agency in the Gulf markets.</li></ul> 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' 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 at 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.

Associate Regulatory Affairs - based in Dubai

Live What you will do Let s do this. Let 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 s corporate and local regulatory requirements </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 (IRLs) and Global Regulatory Leads (GRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.</li> <li> Partners with peers to ensure consistency on procedures. </li> </ul> Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Regulatory Affairs professional we seek is a teammate with these qualifications. Basic Qualifications: <ul> <li> Bachelor`s degree in Pharmaceutical Science </li> <li> Working with policies, procedures and SOP s. </li> <li> Comprehensive understanding of regulatory activities and how they impact other projects and/or processes. </li> <li> Knowledge of the Gulf legislation and regulations </li> <li> 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 </li> <li> Knowledge of regional countries legislation and regulations relating to medicinal products in the Gulf Markets. </li> <li> Experience interacting with regulatory agency 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 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.

Associate Regulatory Affairs

Confidential Company

An International pharmaceutical company based in HQ in Dubai is looking to appoint an officer in its regulatory affairs department. The candidate should be a Pharmacist preferably with postgraduate studies in any scientific field, fluent in English and has at 1-2 years’ experience in registration of medicines. MOH license is mandatory and knowledge in Pharmacovigilance would be a plus.

Pharma Regulatory Affairs Officer

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