regulatory affairs specialist

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 passionate and talented Regulatory Affairs Specialist to join our dynamic team.
The ideal candidate will contribute to our mission of enhancing human health and well-being, ensuring that we meet the highest standards of excellence in our industry.
Key Responsibilities: 
 
<ul><li>Regulatory Compliance &ndash; Ensure all products meet the Egyptian regulations.</li>
<li>Product Registration &ndash; Prepare, submit, and manage dossiers for new drugs, renewals, and variations, guiding approvals from start to finish.</li>
<li>Compliance Monitoring &ndash; Stay ahead of evolving regulations, advising internal teams on critical updates to maintain full compliance.</li>
<li>Labeling &amp; Packaging Review &ndash; Ensure all pharma labeling, packaging, and promotional materials adhere to regulatory standards.</li>
<li>Cross-Functional Collaboration &ndash; Partner with R&amp;D, QA, Manufacturing, and Marketing to embed regulatory requirements at every stage.</li>
</ul>
Requirements<ul>
<li>
Bachelor&rsquo;s degree in Pharmaceutical Sciences.</li>
<li>+2 years of experience in Regulatory Affairs in Egypt Market.
</li><li>Fluent in English (written &amp; verbal) &ndash; essential for global collaboration.</li>
<li>Detail-oriented, proactive, and eager to grow in a dynamic regulatory landscape.</li></ul></div>

Regulatory Affairs Specialist

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. 
Main duties 
<ul>
<li>Completes low and medium complexity regulatory assignments and ensures timely execution of tasks.</li>
<li>Plans, prepares, compiles, and submits high-quality regulatory applications for Egypt in compliance with applicable requirements, and prepares electronic submission files using document management tools such as DocuBridge.</li>
<li>Tracks the status of applications under regulatory review, provides updates to internal and external stakeholders, and maintains regulatory documentation and internal databases such as ARCERA.</li>
<li>Revises and approves artwork for product packaging materials in internal systems according to applicable guidelines and ensures adherence to regulatory compliance and standard operating procedures.</li>
<li>Schedules and organizes meetings with internal and external stakeholders, prepares materials for these meetings, and actively participates in discussions.</li>
<li>Communicates regulatory requirements to other departments, provides regulatory support to project teams and stakeholders, and attends internal trainings in due time.</li>
<li>Forwards all received Product Quality Complaints, Adverse Events, and Medical Information Requests to the relevant teams in Quality Assurance, Pharmacovigilance, and Medical Affairs.</li>
<li>Ensures compliance with applicable legislation, maintains internal regulatory information systems, and supports continuous improvement of regulatory processes.</li>
</ul>
Job Requirements
<ul>
<li>Bachelor&rsquo;s degree in pharmacy, chemistry, biology, or another life science.</li>
<li>Minimum of two years&rsquo; experience in Regulatory Affairs within a relevant discipline; prior experience in a similar role is considered an advantage.</li>
<li>Business English at least at intermediate level</li>
<li>Strong understanding of regulatory requirements, processes, procedures, and submission pathways.</li>
<li>In-depth knowledge of regulatory life cycle management for pharmaceutical products.</li>
<li>Proven ability to collaborate effectively within cross-functional project teams.</li>
<li>Demonstrates alignment with ARCERA principles and organizational values in all actions and decisions.</li>
<li>Exhibits strong verbal and written communication skills, with a high level of accuracy and attention to detail.</li>
<li>Possesses excellent interpersonal skills, with the ability to collaborate effectively across diverse functions, cultures, and organizational levels, including external business partners.</li>
<li>Applies sound project management capabilities to plan, organize, and deliver tasks efficiently.</li>
<li>Shows adaptability and a proactive mindset by embracing challenging assignments and pursuing opportunities that foster professional growth and capability development.</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>

Amros Pharmaceuticals

We're Hiring Senior Regulatory Affairs ExecutiveAmros Pharmaceuticals is seeking a detail-oriented and experienced Senior Regulatory Affairs Executive to handle regulatory submissions, ensure compliance with statutory requirements, and coordinate with regulatory authorities for timely approvals.QualificationBachelor&rsquo;s degree in Pharmacy (Pharm-D)Master&rsquo;s degree in Regulatory Affairs or Pharmaceutical Sciences will be considered a plusExperience3&ndash;5 years of experience in regulatory affairs in pharmaceutical industryHands-on experience in regulatory dossier preparation, product registrations, and renewalsKnowledge of DRAP and other statutory guidelinesKey ResponsibilitiesPrepare, review, and submit regulatory dossiers in CTD/ACTD formatHandle product registrations, renewals, variations, and amendmentsCoordinate with regulatory authorities for approvals and responses to queriesMaintain updated regulatory documentation and recordsLiaise with QA, Production, and other departments for regulatory complianceTrack regulatory timelines and ensure timely submissionsAssist during regulatory inspections and auditsEnsure compliance with company policies and statutory requirementsLocation: Ahsanabad, SITE Area II, KarachiTimings: 8:30 AM &ndash; 5:30 PMApply Now: Send your updated profile to hr.recruitment@amrospharma.comJob Type: Full-timeWork Location: In person

Senior Regulatory Affairs Executive

PRANIC DRUG STORE LLC

Job Description: We are seeking a Regulatory Affairs Pharmacist to handle product registration and regulatory activities in the Sultanate of Oman. The ideal candidate will liaise with the Ministry of Health (MOH) and other relevant authorities to ensure our products meet all local regulatory requirements. This is an excellent opportunity for a motivated pharmacist to grow in regulatory affairs and make a meaningful impact in the pharmaceutical industry.Key Responsibilities:<ul><li>Prepare, compile, and submit product registration dossiers to the Omani Ministry of Health.</li><li>Ensure all product documentation, labeling, and packaging comply with local regulations.</li><li>Follow up with MOH on product registration approvals.</li><li>Maintain accurate regulatory records and track progress of submissions.</li><li>Provide guidance on regulatory compliance for internal teams.</li><li>Assist with any audits or inspections as required.</li></ul>Requirements:<ul><li>Bachelor&rsquo;s degree in Pharmacy (BPharm / PharmD).</li><li>0&ndash;5 years of experience in the pharmaceutical industry.</li><li>Valid Sultanate of Oman Pharmacist License is mandatory.</li><li>Knowledge of MOH regulations and product registration processes is a plus.</li><li>Strong organizational and communication skills.</li><li>Ability to work independently and manage multiple tasks.</li></ul>Why Join Us:<ul><li>Opportunity to grow and gain experience in regulatory affairs.</li><li>Work in a dynamic team environment.</li><li>Contribute to bringing quality healthcare products to Oman.</li></ul>How to Apply: Interested candidates should submit their CV and a copy of their valid Sultanate of Oman pharmacist license to pranicdrugstorellc@gmail.com or apply directly via Indeed.Job Type: Full-time

Regulatory Affairs Pharmacist – Oman Experience Mandatory

Julphar

<div></div><div><div><div><div><div>At Julphar, we are on a journey of culture transformation &amp; our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.
Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.

Job Summary/Main Purpose 


The RA Sr Associate must ensure to adhere to the cGMP principles and maintain them in an effective manner. 


The regulatory affairs RA Sr Associate work description entails assisting in obtaining and maintaining government approval for materials such as drugs, medical devices, nutritional products, and several other related materials. Regulatory affairs specialists are also responsible for collecting, gathering, compiling, and preparing the dossier needed for registration and submission to regulatory agencies. 


The regulatory affairs RA Sr Associate will report to Manager &ndash; Regulatory Affairs and efficiently conduct all duties and responsibilities assigned and or delegated by the Team Lead. Must ensure to support RA team members as per the need of the function. 


 Key Responsibilities &amp; Key Result Areas 


 Prepare, review, and submit regulatory dossiers for registrations, renewals, variations, and post-approval changes in CTD/eCTD format.

 Coordinate with health authorities for submissions, deficiency responses, follow-ups, and regulatory meetings.

 Ensure compliance with applicable regulations, guidelines, and internal SOPs; monitor and implement regulatory updates.

 Collaborate with Quality, Clinical, CMC, PV, and Supply Chain teams to support submissions, labelling, and lifecycle activities.

 Maintain regulatory records, submission trackers, and approval documentation.

 Support process improvements and provide guidance to junior regulatory team members. 


Core Competency
<ul>
<li>Strong knowledge of regulatory requirements and submission processes.</li>
<li>Excellent written and verbal communication skills.</li>
<li>Strong organizational skills with the ability to manage multiple priorities.</li>
<li>High attention to detail and compliance mindset.</li>
<li>Ability to work independently and collaboratively in cross-functional teams.</li>
<li>Must have a teamwork attitude &amp; ability to apply common sense understanding to carry out multi-step instructions</li>
</ul><ul><li>Must be highly organized, self-motivated to learn new things and implement them at workplace</li></ul> 


Qualifications,
Key Experiences / Functional Knowledge Requirements 

<ul>
<li>Bachelors (4 years) / master&rsquo;s degree in pharmacy</li>
<li>Minimum 1-2 years of experience working in similar role in pharmaceuticals industry</li>
</ul>
We value people from different backgrounds. Could this be your story? Apply today or visit www.Julphar.net to read more about us and the journey of Julphar</div></div></div></div></div>

Ra Sr. Associate

Job Title: Pharmacist &ndash; GCC Regulatory ExperienceLocation: Office 2116, 21st Floor, The Burjuman Business Tower, Al Mankhool, Sheikh Zayed Road, Dubai, UAE Salary: AED 5,000 &ndash; 10,000 per month Job Type: Full‑timeAbout the Company: Pranic Drug Store LLC is a Dubai‑based pharmaceutical and healthcare product provider with strong regional presence, offering high‑quality medicines, medical kits, OTC products, cosmeceuticals, and regulatory support in the GCC market.Job Description: We are seeking a dedicated Pharmacist with strong regulatory experience within the GCC region to join our team. This role involves ensuring compliance with regulatory authorities, accurate dispensing, and supporting product registration and documentation.Key Responsibilities:<ul><li>Ensure compliance with GCC regulatory requirements for pharmaceutical products.</li><li>Support regulatory submissions and documentation to health authorities.</li><li>Manage pharmacy operations and maintain accurate records.</li><li>Dispense medications and counsel patients on proper usage.</li><li>Coordinate with internal and external regulatory teams.</li></ul>Requirements:<ul><li>Valid MOH (UAE) pharmacist license.</li><li>Driving license (UAE).</li><li>At least 3 years of relevant experience, preferably with GCC regulatory exposure.</li><li>Must hold own UAE visa.</li><li>Excellent communication and organizational skills.</li></ul>Preferred Experience:<ul><li>Experience with regulatory affairs, pharmacovigilance or product compliance within GCC markets.</li><li>Familiarity with UAE &amp; GCC health authority requirements.</li></ul>Job Type: Full-time

Pharmacist – GCC Regulatory Experience

Freight Hub Shipping LLC

Job Title: Dangerous Goods Regulations (DGR) SpecialistLocation: DUBAI Company: FREIGHT HUB SHIPPING LLC Employment Type: Full-time<ul><li>Ensure all shipments containing dangerous goods comply with IATA, IMDG, ADR, and other relevant DGR regulations.</li><li>Review and verify dangerous goods declarations, labeling, marking, and packaging.</li><li>Coordinate with teams to ensure safe and compliant handling of DG shipments.</li><li>Maintain up-to-date knowledge of all DGR regulatory changes and communicate updates internally.</li><li>Provide guidance to staff regarding DG documentation and handling procedures.</li><li>Liaise with airlines, shipping lines, and regulatory authorities for DG shipment approvals and compliance.</li><li>Conduct internal audits and ensure corrective actions are implemented.</li><li>Prepare and maintain DG compliance reports and documentation.</li></ul>Qualifications &amp; Experience:<ul><li>Minimum 1 years of experience handling Dangerous Goods in the freight forwarding or logistics industry.</li><li>Valid IATA DGR Certification (current and up to date) &mdash; mandatory.</li><li>Strong knowledge of IATA DGR, IMDG Code, ADR, and other relevant transport regulations.</li><li>Familiarity with MSDS/SDS documentation and DG classification.</li><li>Excellent communication and coordination skills.</li><li>Attention to detail and strong problem-solving abilities.</li><li>Proficient in MS Office and logistics management systems and to create the DGD as per IATA standard .</li></ul>To Apply: Please send your CV and relevant certifications to [info@freighthub.ae, Hr@freighthub.ae] with the subject line &ldquo;Application &ndash; DGR Specialist. Job Type: Full-time

Dangerous Goods Regulations (DGR) Specialist

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3672 regulatory affairs specialist jobs NEAR_ME

Regulatory Affairs Specialist

Regulatory Affairs Specialist

Senior Regulatory Affairs Executive

Regulatory Affairs Pharmacist – Oman Experience Mandatory

Ra Sr. Associate

Pharmacist – GCC Regulatory Experience

Dangerous Goods Regulations (DGR) Specialist