regulatory affairs coordinator

Peergrowth Consultancy Co.

We are seeking a detail-oriented and proactive Regulatory Affairs Coordinator to support regulatory activities at our UAE-based manufacturing facility. This role is responsible for compiling and coordinating product and site-specific regulatory dossiers for submission to global health authorities, including support for GMP audits. The ideal candidate will collaborate closely with Quality Assurance (QA), manufacturing, and technical teams at the site, as well as regional regulatory teams. Experience with local UAE and GCC regulatory requirements is preferred, with an understanding of global CTD requirements.KEY RESPONSIBILITIES<ul><li>Collate, compile, and review regulatory dossiers for product and site registrations in various international markets, including GMP audit dossiers.</li><li>Ensure accuracy, completeness, and regulatory compliance of all documentation submitted.</li><li>Review and verify the correctness and regulatory alignment of Artwork (AW) prior to submission.</li><li>Act as a key liaison between regional regulatory teams and site-based technical functions (QA, QC, Production, Engineering).</li><li>Coordinate technical responses and ensure timely resolution of queries raised by health authorities during or post submission through regional RA teams.</li><li>Maintain an organized and up-to-date archive of all regulatory submissions made from the site.</li><li>Implement proper version control, submission tracking, and document retrieval protocols.</li><li>Monitor submission timelines and follow up with internal teams to ensure timely completion of deliverables.</li><li>Ensure alignment with both international regulatory expectations and local UAE / GCC requirements.</li><li>Provide regular status updates on submissions and queries to the Head of International Regulatory Affairs.</li><li>Support documentation requests for internal audits, inspections, and compliance reviews.</li></ul>CANDIDATE EXPERIENCE<ul><li>Bachelors or masters degree in pharmacy (preferred)</li><li>2 to5 years of experience in Regulatory Affairs, ideally in a manufacturing or site-based setting within the pharmaceutical industry.</li><li>Preferred : Experience with handling guidelines of UAE Ministry of Health (MoHAP), GCC-DR, Oman, Bahrain, or other Gulf regulatory bodies.</li><li>Practical knowledge of CTD / eCTD dossier formats and GMP audit preparation.</li></ul>Key Skills and Competencies<ul><li>Strong communication, collaboration, and coordination skills across technical and regulatory functions.</li><li>High level of accuracy, attention to detail, and document management capabilities.</li><li>Ability to manage multiple priorities, meet deadlines, and adapt to dynamic regulatory requirements.</li><li>Proficient in Microsoft Office (Word, Excel, PowerPoint) and document control systems.</li><li>Proactive approach to problem-solving and handling regulatory queries.</li></ul>Coordinator • Dubai, United Arab Emirates

Regulatory Affairs Coordinator

Minerva Research Solutions

<div>
 
 Company Overview:
 
 
 
 Minerva Research Solutions is a clinical trial management service provider. We aim to transform the landscape of healthcare and research with our quality clinical services. We support the biotech, medical, and pharma industries through all phases of the clinical trial lifecycle.
 
 
 Our services include Data Operation, Recruitment Services, and Regulatory. Our goal is to speed up the lifecycle of novel therapies through streamlined processes, stringent timelines &amp; real-time solutions. Our clinical trial support services &amp; consultations are tailored to foster your product and requirements.
 
 
 We aim to deliver high-quality data and solutions to make your clinical trials a success. We follow stringent FDA and GCP regulations throughout all phases of the clinical trial process.
 
 
 
 Job Purpose:
 
 
 
 The Coordinator - Regulatory Affairs is responsible for working as a team member of regulatory professionals in ensuring regulatory compliance of company products and activities, including the preparation and submission of regulatory documents, the management of regulatory inspections, and the development and implementation of regulatory strategies.
 
 
 
 Key Responsibilities:
 
 
 
 <ul>
 <li>
 Working as a regulatory professional to ensure effective and efficient regulatory support for the company's products and activities
 </li>
 <li>
 Develop and implement regulatory strategies that support the company's business objectives and ensure compliance with relevant regulations and guidelines
 </li>
 <li>
 Manage the preparation and submission of regulatory documents, including regulatory filings, registrations, and certifications
 </li>
 <li>
 Coordinate and manage regulatory inspections and audits, and ensure appropriate corrective and preventive actions are taken in response to any findings
 </li>
 <li>
 Keep abreast of changes in regulatory requirements and guidelines, and communicate these changes to relevant stakeholders in a timely manner
 </li>
 <li>
 Build and maintain positive relationships with regulatory authorities and other external stakeholders
 </li>
 <li>
 Provide regulatory guidance and support to cross-functional teams, including product development, clinical research, manufacturing, and quality assurance
 </li>
 <li>
 Collaborate with internal and external stakeholders to develop and implement regulatory policies and procedures that support the company's overall goals and objectives
 </li>
 <li>
 Ensure timely and accurate reporting of regulatory activities and metrics
 
 
 </li>
 </ul>
 
 Qualifications:
 
 
 
 <ul>
 <li>
 Bachelor's degree in a scientific discipline, preferably in life sciences, chemistry, or pharmacy
 </li>
 <li>
 01 years of experience in regulatory affairs, fresh graduates will also be preferred
 </li>
 <li>
 In-depth knowledge of global regulatory requirements and guidelines for pharmaceuticals, medical devices, or other regulated products
 </li>
 <li>
 Excellent communication, interpersonal, and problem-solving skills
 </li>
 <li>
 Ability to work independently and manage multiple projects simultaneously
 </li>
 <li>
 Strong attention to detail and accuracy
 </li>
 <li>
 Experience working in a fast-paced, deadline-driven environment
 
 
 </li>
 </ul>
 
 Benefits:
 
 
 
 <ul>
 <li>
 Competitive salary and performance-based bonuses
 </li>
 <li>
 Medical health insurance coverage
 </li>
 <li>
 Employees Old-age benefits coverage
 </li>
 <li>
 Professional learning and development support
 </li>
 <li>
 Generous vacation and paid time off
 </li>
 <li>
 Employee assistance programs for mental health
 </li>
 <li>
 Company-sponsored events and team-building activities
 </li>
 <li>
 Diverse, professional, and inclusive work environment
 </li>
 <li>
 Opportunities for career growth
 </li>
 <li>
 Cutting-edge technology and tools
 </li>
 <li>
 Family-friendly policies, including parental leave
 </li>
 <li>
 Commuter benefits or transportation assistance
 </li>
 <li>
 Social responsibility and community involvement programs
 
 
 </li>
 </ul>
 
 Openings:
 
 
 
 04 positions
 
 
 Full-time
 
 
 On-site job
 
 
 
 Work Schedule Timings:
 
 
 
 Monday to Friday
 
 
 Evening Shift (07 PM to 03 AM)
 
 
 (transport facility provided for female staff only and allowance for male employees, additional night shift allowance)
 
 
 Powered by JazzHR
 
 
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</div>

Regulatory Co Ordinator(Evening Shift)

<div>Company Overview: 
 
Minerva Research Solutions is a clinical trial management service provider. We aim to transform the landscape of healthcare and research with our quality clinical services. We support the biotech, medical, and pharma industries through all phases of the clinical trial lifecycle. 
Our services include Data Operation, Recruitment Services, and Regulatory. Our goal is to speed up the lifecycle of novel therapies through streamlined processes, stringent timelines &amp; real-time solutions. Our clinical trial support services &amp; consultations are tailored to foster your product and requirements. 
 
We aim to deliver high-quality data and solutions to make your clinical trials a success. We follow stringent FDA and GCP regulations throughout all phases of the clinical trial process. 
 
Job Purpose: 
 
The Coordinator - Regulatory Affairs is responsible for working as a team member of regulatory professionals in ensuring regulatory compliance of company products and activities, including the preparation and submission of regulatory documents, the management of regulatory inspections, and the development and implementation of regulatory strategies. 
 
Key Responsibilities:<ul><li>
Working as a regulatory professional to ensure effective and efficient regulatory support for the company's products and activities.</li><li>
Develop and implement regulatory strategies that support the company's business objectives and ensure compliance with relevant regulations and guidelines.</li><li>
Manage the preparation and submission of regulatory documents, including regulatory filings, registrations, and certifications.</li><li>
Coordinate and manage regulatory inspections and audits, and ensure appropriate corrective and preventive actions are taken in response to any findings.</li><li>
Keep abreast of changes in regulatory requirements and guidelines, and communicate these changes to relevant stakeholders in a timely manner.</li><li>
Build and maintain positive relationships with regulatory authorities and other external stakeholders.</li><li>
Provide regulatory guidance and support to cross-functional teams, including product development, clinical research, manufacturing, and quality assurance.</li><li>
Collaborate with internal and external stakeholders to develop and implement regulatory policies and procedures that support the company's overall goals and objectives.</li><li>
Ensure timely and accurate reporting of regulatory activities and metrics.</li></ul>
Qualifications:<ul><li>
Bachelor's degree in a scientific discipline, preferably in life sciences, chemistry, or pharmacy.</li><li>
01 years of experience in regulatory affairs, fresh graduates will also be preferred</li><li>
In-depth knowledge of global regulatory requirements and guidelines for pharmaceuticals, medical devices, or other regulated products.</li><li>
Excellent communication, interpersonal, and problem-solving skills.</li><li>
Ability to work independently and manage multiple projects simultaneously.</li><li>
Strong attention to detail and accuracy.</li><li>
Experience working in a fast-paced, deadline-driven environment.</li></ul>
Benefits:<ul><li>
Competitive salary and performance-based bonuses.</li><li>
Medical health insurance coverage.</li><li>
Employees Old-age benefits coverage.</li><li>
Professional learning and development support.</li><li>
Generous vacation and paid time off.</li><li>
Employee assistance programs for mental health.</li><li>
Company-sponsored events and team-building activities.</li><li>
Diverse, professional, and inclusive work environment.</li><li>
Opportunities for career growth.</li><li>
Cutting-edge technology and tools.</li><li>
Family-friendly policies, including parental leave.</li><li>
Commuter benefits or transportation assistance.</li><li>
Social responsibility and community involvement programs.</li></ul>
Openings:
04 positions 
Full-time 
On-site job 
 
Work Schedule Timings: 
Monday to Friday 
Evening Shift (07 PM to 03 AM) 
(transport facility provided for female staff only and allowance for male employees, additional night shift allowance)
bK2MpLypay</div>

Thermo Fisher Scientific

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, you&rsquo;ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world&rsquo;s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information
This position is located in Austin, Texas, and is part of the Regulatory Affairs group. This position functions within an office setting, following a typical Monday to Friday work schedule. The ability to work in-office in Austin, TX is required for 50% of the time.
Discover Impactful Work
Join us to help build the future of science and healthcare by ensuring regulatory compliance in our innovative Animal Health product lines. The Regulatory Affairs Specialist III will be responsible for defining and implementing regulatory strategy, providing regulatory guidance and support to product development teams for planning, design and development, and post-market surveillance and compliance activities.
A day in the Life<ul><li>
Write, coordinate, compile, and submit regulatory documents to agencies, focusing on the USDA for the Animal Health product portfolio.</li><li>
Engage regulators in oral and written communications to discuss submissions, requirements, and address questions.</li><li>
Serve as RA subject matter expert, staying current on Animal Health regulations, guidance documents, notices, and competitor news.</li><li>
Coordinate regulatory issue resolution using internal resources, agencies, and outside consultants.</li><li>
Conduct trainings and communicate materials to enhance team knowledge of regulated environments.</li><li>
Review and approve labeling, packaging, advertising, and promotional materials for regulatory compliance.</li><li>
Participate in business meetings with internal collaborators and external partners.</li><li>
Collaborate with global regulatory professionals, providing guidance on strategies, submissions, and projects.</li></ul>
Keys to Success
Education<ul><li>
Minimum requirement of a Bachelor&rsquo;s degree in life sciences, bio-engineering or related science.</li></ul>
Experience<ul><li>
A minimum of 2-4 years of proven experience in Animal Health Diagnostic (preferred) or Human IVD Regulatory Affairs. This experience may include a combination of Animal Health VDx as well as US IVD and CE-IVD experience.</li><li>
Demonstrated ability to maintain regulatory permits and licenses.</li><li>
Proficiency in preparing regulatory compliance reports and performing regulatory surveillance.</li></ul>
Knowledge, Skills, Abilities<ul><li>
Experience in regulatory affairs, including strategy creation and development control.</li><li>
Outstanding attention to detail and time management skills.</li><li>
Excellent interpersonal, customer orientation, and presentation skills.</li><li>
Provided regulatory guidance on project teams.</li><li>
Detail-oriented for regulatory reviews.</li><li>
Skilled in multi-tasking and business impact</li><li>
Effective in matrixed environments and conflict resolution.</li></ul>
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!</div>

Regulatory Affairs Specialist - Animal Health (Austin, TX)

Manpower Türkiye

<div>
 
 We are looking for a
 
 "Regulatory Affairs Assistant to Specialist"
 
 on behalf of a client to whom we provide consultancy services, operating in the hearing aids and medical equipment industry.
 
 
 
 
 
 
 Job Definition
 
 
 
 
 
 
 &bull; Support the preparation, review, and submission of regulatory documentation in compliance with local and international requirements.
 
 
 &bull; Assist in maintaining regulatory files and product registration databases.
 
 
 &bull; Support audit and inspection preparation activities as needed.
 
 
 &bull; Collaborate effectively with different business teams to ensure smooth regulatory processes and timely submissions.
 
 
 
 
 
 
 Qualifications
 
 
 
 
 
 
 &bull; Bachelor&rsquo;s degree in Pharmacy, Biomedical Engineering, Chemistry, Biology, or a related life sciences field.
 
 
 &bull; Up to 1 year of professional experience in Regulatory Affairs or related areas in medical device sector.
 
 
 &bull; Strong communication and coordination skills, with the ability to work effectively across departments.
 
 
 &bull; Excellent attention to detail and organizational skills.
 
 
 &bull; Fluency in English (both written and spoken) is required.
 
 
 &bull; Proficiency in MS Office applications.
 
 
 
 
 
 
 
 
 
 Please note that only the candidates that fulfill these requirements will be considered and shortlisted candidates will be contacted. LinkedIN &uuml;zerinden elektronik olarak iletece&gbreve;iniz ki&scedil;isel bilgileriniz, 6698 say&inodot;l&inodot; Ki&scedil;isel Verilerin Korunmas&inodot; Kanunu ve ilgili mevzuat &ccedil;er&ccedil;evesinde, Experis T&uuml;rkiye (Manpower Group T&uuml;rkiye) taraf&inodot;ndan yaln&inodot;zca &Scedil;irketimizden talep etti&gbreve;iniz hizmetlerin sunulabilmesi ve bu hizmetlerin s&uuml;reklili&gbreve;inin sa&gbreve;lanmas&inodot; ama&ccedil;lar&inodot;yla saklanabilecek, i&scedil;lenebilecek ve verilen servisin gerektirdi&gbreve;i hallerde yurti&ccedil;inde ve yurtd&inodot;&scedil;&inodot;nda yerle&scedil;ik 3. ki&scedil;ilerle payla&scedil;&inodot;labilecek olup, ki&scedil;isel verileriniz hi&ccedil;bir &scedil;ekilde hukuka ve d&uuml;r&uuml;stl&uuml;k kural&inodot;na ayk&inodot;r&inodot; &scedil;ekilde ba&scedil;kalar&inodot; ile payla&scedil;&inodot;lmayacak ve i&scedil;leme sebebi d&inodot;&scedil;&inodot;nda ba&scedil;ka ama&ccedil;larla kullan&inodot;lmayacakt&inodot;r. Ki&scedil;isel verileriniz yaln&inodot;zca i&scedil;leme amac&inodot;n&inodot;n gerekli k&inodot;ld&inodot;&gbreve;&inodot; s&uuml;re boyunca saklanacak olup talebiniz &uuml;zerine silinecek veya imha edilecektir. Detayl&inodot; bilgiye https://www.experis.com.tr/site/kisisel-verilerin-korunmasi/39 linkinden ula&scedil;abilirsiniz. Bu i&scedil;e ba&scedil;vurarak, &ouml;zge&ccedil;mi&scedil;inizin veritaban&inodot;m&inodot;zda yer almas&inodot;n&inodot; kabul etmi&scedil; oldu&gbreve;unuzu bildirmek isteriz.
 
 
 
 
</div>

Regulatory Affairs Assistant to Specialist

Venco Imtiaz Contracting Co

Job SummaryThe Assistant NOC Coordinator plays a pivotal role in ensuring seamless coordination with government authorities and utility service providers to secure all necessary permits, approvals, and No Objection Certificates (NOCs) required for construction and operational activities. This role involves managing regulatory compliance, facilitating inspections, and overseeing documentation related to legal, environmental, and labor requirements. The ideal candidate will possess strong organizational skills, a deep understanding of UAE regulatory frameworks, and the ability to liaise effectively with internal teams and external stakeholders.Key Responsibilities<ul><li>Coordinate with local authorities to obtain necessary permits, approvals, and clearances for construction projects.</li><li>Ensure that all projects comply with local regulations, building codes, and standards, including safety and environmental guidelines.</li><li>Handle the entire No Objection Certificate (NOC) process, including application preparation, submission, and follow-up with relevant authorities.</li><li>Communicate with utility companies (e.g., water, electricity, telecommunications) to arrange service connections, disconnections, and relocations.</li><li>Manage and organize documentation for regulatory submissions, including architectural plans, safety reports, and environmental assessments.</li><li>Liaise with government departments to schedule and facilitate inspections, site visits, and certifications during various project stages.</li><li>Track and monitor the status of permits, NOCs, and other regulatory approvals to ensure timely completion and compliance.</li><li>Ensure timely renewal and updates of licenses, permits, and other documentation to prevent project delays.</li><li>Assist in resolving issues, concerns, or disputes with local authorities or utility companies during the project lifecycle.</li><li>Maintain comprehensive records of all NOCs, permits, and regulatory approvals for audit and compliance purposes.</li><li>Manage and process employee visas, work permits, residency applications, and renewals in line with UAE immigration laws.</li><li>Facilitate complex medical and police procedures in the event of an employee or next-of-kin death.</li><li>Coordinate with government authorities for company registrations, trade licenses, and other legal requirements.</li><li>Foster effective communication with government departments, including labor, immigration, and municipal authorities.</li><li>Assist in resolving labor disputes and ensure compliance with labor laws and employee welfare standards.</li><li>Prepare and submit reports and documentation to government authorities as required by law.</li><li>Stay informed on changes in government regulations and ensure organizational compliance with all legal obligations.</li></ul>Qualifications &amp; Skills<ul><li>Bachelor&rsquo;s degree in Business Administration, Public Relations, Law, or a related field.</li><li>3&ndash;5 years of experience in NOC coordination, government relations, or regulatory affairs, preferably within the UAE.</li><li>In-depth knowledge of UAE government procedures, labor laws, and regulatory frameworks.</li><li>Strong communication and interpersonal skills to effectively liaise with authorities and internal teams.</li><li>Proficiency in Arabic and English is highly desirable.</li><li>Excellent organizational and documentation skills with attention to detail.</li><li>Ability to manage multiple tasks and meet tight deadlines.</li><li>Proficient in Microsoft Office Suite and document management systems.</li><li>Problem-solving mindset with a proactive and diplomatic approach.</li></ul>Job Type: Full-timeApplication Question(s):<ul><li>How soon you can join ?</li><li>What is your salary expectation ?</li></ul>

Assistant NOC Coordinator

Acino

<div>Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide. 
This position is based in Cairo, Egypt and will report directly to the Regulatory Affairs Manager, META. The role will be responsible to support on all the assigned Regulatory activities within the Non-Direct Markets (NDM) region (Sudan, Libya, Yemen, Morocco, Jordan and Lebanon). The role will also ensure all Regulatory activities are conducted in compliance with local regulations and company policies and SOPs. Manage Business Partners within the NDM region. 
Your Responsibilities will be: 
<ul>
<li>
Support the Regulatory Affairs Manager on all the assigned Regulatory activities within the NDM.</li>
<li>Keep up-to-date and archive all relevant regulations and Regulatory guidelines (Regulatory Intelligence); inform Global RA on any changes/updates to the local requirements.</li>
<li>Manage the preparation, submission, and follow-up of all regulatory applications in the assigned region (variations, product renewals, site registration renewals, new registrations etc.).</li>
<li>Initiate the preparation and translation of proofread printed artwork ensuring compliance with the registered Product Information.</li>
<li>Responsible of ordering and legalization of local CPP and other module 1 documents for local products.</li>
<li>Perform regulatory due diligence on module 1 for all assigned products for NDM according to internal process/guidance according to EU/local Region regulatory requirements.</li>
<li>Ensure that the regulatory file is complete and available for dispatch to the distributor and timely submitted to the local Health Authorities.</li>
<li>Work closely with Global RA on the submission strategy and the completion of the regulatory dossiers in line with local regulations.</li>
<li>Co-ordinate the responses to requests by the authorities during the evaluation process and check the correct handling of deficiency letters within a specific timeframe.</li>
<li>Create and maintain a full up-to-date database and archiving system for tracking the regulatory activities in the assigned region.</li>
<li>Adhere to Acino internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance training.</li>
<li>Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.</li>
<li>All trainings to be completed as per training plan.</li></ul> 


Your Profile: 
<ul>
<li>
Education in Pharmacy, natural Sciences or relevant discipline.</li>
<li>Minimum of 3 years&rsquo; experience working in the Pharmaceutical industry in Regulatory Affairs and extensive experience in preparation and submission of Regulatory files to local Competent Authorities in the region.</li>
<li>Proven ability to effectively work collaboratively in cross functional teams.</li>
<li>Ability to work in a highly dynamic business environment.</li>
<li>Cross-cultural awareness and ability to work across geographical markets.</li>
<li>Multi-task ability and work well under pressure and tight deadlines.</li></ul> 


This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!</div>

Regulatory Affairs Specialist NDM

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