regulatory affairs specialist

AMICO Group

<div>
 <strong>
  Job Purpose
  <br/>
  <br/>
 </strong>
 Under general direction of the Regulatory Affairs Manager, the RA Specialist will do the required registrations on line and all related job requirements including communication with both teams at the supplier's side and inside Amico.
 <br/>
 <br/>
 <strong>
  Key Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Understanding the registration requirements for several countries
  </li>
  <li>
   Requesting suppliers to provide different documents required for the registration
  </li>
  <li>
   Feeding the different governmental systems with the required registration information and uploading needed documents.
  </li>
  <li>
   Understanding the Comments received from the Authorities on any registration and passing it to the supplier in an easy understandable manner.
  </li>
  <li>
   Attending Conference calls with suppliers, prioritizing the requirements, conveying the needed tasks in an understandable manner
  </li>
  <li>
   Maintaining the Archive system
  </li>
  <li>
   Ability to bridge the communications between Authorities/our local agents in the countries with the supplier
  </li>
  <li>
   Follow the internal regulations in Amico
  </li>
  <li>
   Other regulatory activities such as classification, prequalification and recalls
  </li>
  <li>
   Communicating with the legal department in Amico for all legal concerns.
  </li>
  <li>
   Update the SOPs related to our processes when needed
  </li>
  <li>
   Close follow up for all pending issues
  </li>
  <li>
   Preparing reports related to the progress of work
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Job Requirements
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor&rsquo;s degree or equivalent in Science, Pharmacy, Biomedical Engineering, Business Administration or Legal
  </li>
  <li>
   3 years of experience in Regulatory Affairs with regional company (wide range of products)
  </li>
  <li>
   Worked for Medical Device Registration outside Egypt or to register Egyptian products with other countries
  </li>
  <li>
   Excellent Knowledge of MS Office.
  </li>
  <li>
   Fluent in English language
  </li>
  <li>
   Knowing the Pharmaceutical registration process
  </li>
  <li>
   Previous experience in registrations in the Gulf will be an added value
  </li>
  <li>
   Having a certificate in Quality or Regulatory Affairs will be an added Value
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Why Join Us
  <br/>
  <br/>
 </strong>
 <strong>
  At AMICO, we believe in fostering a diverse and inclusive workplace. We recognize the value that different perspectives and experiences bring to our company.
  <br/>
  <br/>
 </strong>
 <strong>
  As part of our commitment to diversity, we encourage applications from all individuals as part of our inclusive hiring practices.
  <br/>
  <br/>
 </strong>
 <strong>
  This initiative is part of our broader diversity agenda aimed at creating a balanced and innovative workforce
 </strong>
</div>


Regulatory Affairs Specialist

SERVIER

<div></div><div><div><div><div><div><b>Date posted: </b>Sep 10, 2025
</div></div></div></div><div><div><div><div><b>City: </b>Riyadh
</div></div></div></div><div><div><div><div><b>Country/Region: </b>SA
</div></div></div></div><div><div><div><div><b>Type of Contract: </b>Full-time Employment / Unlimited
</div></div></div></div><div><div><div><div><b>Job Requisition ID: </b>9758
</div></div></div></div><div></div><div><div><div><div><p>Regulatory Affairs Specialist - KSA
</p></div></div></div></div><div><div><div><div><div>.</div>
<p><b>
Job Purpose</b></p>
<ul>
<li>The Regulatory Affairs Specialist focuses on ensuring that the organization meets all of the applicable regulations. Their goal is to ensure that new products meet certain requirements as set by Health Authorities.</li>
<li>Regulatory Affairs Specialist ME is responsible for Saudi Arabia activities (KSA).</li>
<li>Identifying all elements and actions necessary for registering and maintaining valid marketing authorizations in KSA.</li>
<li>Collaboration with the local partners, local authorities and WRA in France.</li>
<li>Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals or registrations.</li>
<li>Handle registrations of new products/sites/medical devices, pricing as well as maintaining life cycle of products in KSA, including renewals and variations.</li>
<li>Ensure that all relevant regulations are fully met in dossiers, with the aim of complying with the requirements established by Health Authorities.</li>
<li>Collaborates closely with the Department Head in all department related tasks and activities.</li>
<li>Compile and prepare new products and manufacturing sites registration files for submissions to authorities in KSA as per Regulatory timelines.</li>
<li>Cross functionality &amp; collaboration with Global teams as well as all ME departments, provide regulatory support and guidance whenever required.</li></ul><br>
<p></p>
<p><b>
Role Responsibilities</b></p>
<p><b>
Life-Cycle </b><b>management of products</b></p>
<ul>
<li>Pre-registration coordination with WRA and preparation of documentation for KSA to compile the product and manufacturing site files, Review/ Preparation/Submission of dossiers, fees, inquiries, answers to questions, approvals...</li>
<li>Life-cycle management of products that includes new registrations, renewals/minor variation of both products and sites.</li>
<li>Follow country specific procedures and SFDA guidelines in the KSA market.</li>
<li>Coordination &amp; liaising with WRA teams/distributors for preparation of all types of regulatory dossiers &amp; local documentation.</li>
<li>Preparation of price forms and related documentation for new product registration files.</li>
<li>Liaising with WRA, agents and authorities for documentation submission and follow-up and keep track.</li>
<li>To keep track of the registration status of products with submission, registration, expiry dates.</li>
</ul>
<p><b>Regulatory Tasks</b></p>
<ul>
<li>Closely collaborate with the Head of the Department for all regulatory tasks.</li>
<li>Monthly Reports, Correspondences/Mails, Scientific Office Renewal at the SFDA.</li>
<li>Involved actively in the budget preparation of KSA Regulatory Affairs.</li>
<li>Follow-up on regulatory guidelines and ensure sharing of regulatory information with all concerned.</li>
<li>Reference standard submissions to the authorities.</li>
<li>Helping the Supply Chain Department for tenders - preparation of documentation for institutional tender submissions.</li>
<li>Actively involved in Regulatory Audits.</li></ul><br>
<p></p>
<p><b>
Regulatory Site Management
</b></p><ul><li>For all activities related to KSA -WRA Portal, Ereca, Solaris, LSRIMS, Cosac.</li>
</ul>
<p><b>Other related tasks</b></p>
<ul>
<li>Management/Organizing department supported conferences for Health Authorities in the ME countries.</li>
<li>Liaise closely with agent and Health Authorities in KSA.</li>
<li>Responsible for Change Controls for Variations for the ME region.</li>
<li>Work as a deputy for the local responsible person for advertisement/promotional material.</li>
<li>Deputy Local Responsible person for validation of Packaging Items.</li>
<li>Cross collaboration with other ME departments.</li></ul><br>
<p></p>
<p><b>
Dimensions</b></p>
<ul>
<li>Geographical span: ME - KSA.</li>
<li>Work with the ME Regulatory Lead to develop a detailed understanding of regulatory guidelines and technical requirements in KSA.</li>
<li>Life cycle management of products, understanding of industry-specific regulations, audit procedures, and the ability to ensure compliance with regulatory standards.</li>
<li>Work and support the KSA Regulatory Affairs team.</li>
<li>Cross-functionality with other departments.</li>
<li>Report to the Head of the Department.</li></ul><br>
<p></p>
<p><b>
Requirements</b></p>
<p><b>
Educational</b><b> </b><b>qualifications</b></p>
<ul>
<li>Bachelor&rsquo;s Degree in Pharmacy / Science.</li>
</ul>
<p><b>Relevant Experience</b></p>
<ul>
<li>3+ years of relevant pharmaceutical regulatory experience within a large multinational organization.</li>
<li>Experience working in Saudi Arabia (preferred).</li>
<li>Experience of working within a Global pharmaceutical company would be an advantage.</li></ul><br>
<p></p>
<p><b>
Skills &amp; Personal characteristics</b></p>
<ul>
<li>Good knowledge of the Regulatory environment and procedures in KSA.</li>
<li>Sharp Regulatory Intelligence.</li>
<li>Ability to work cross functional to resolve complex issues.</li>
<li>Strategic thinker, innovative, able to drive multiple-simultaneous initiatives, able to work under pressure, team player.</li>
<li>Multi-tasking, organized, Process &amp; Result oriented, Focused, Problem solving, good judgment and decision-making capability.</li>
<li>Excellent interpersonal, Negotiation and relationship building skills.</li>
<li>Excellent interpersonal, communication &amp; digital skills.</li>
<li>Written and spoken fluency in English &amp; Arabic (French is an added advantage).</li></ul><br>
<div></div>
<div>Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.</div><br>
<div></div>
<div>At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.</div></div></div></div></div></div><p></p>

Regulatory Affairs Specialist - KSA

Zahrawi Medical

<p></p><div><div><div><div><div><h6 class="jobSectionHeader"><b>About Zahrawi Group</b></h6>
<p>Zahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE, KSA, Qatar, Bahrain, &amp; Oman markets. The company supplies and distributes high-quality products and services to Hospitals, Clinics, Laboratories, &amp; Analytical Industries.
</p></div><div><h6 class="jobSectionHeader"><b>job Brief</b></h6>
The incumbent is responsible for all Product Classification/Manufacturing Site Registration and Product Registration and to ensure that all documents required are available and are submitted on time.
</div><div><div><p>They are also responsible for the preparation of the pre- and final permits for the imported items as per the SFDA guidelines.</p><p><b>
ACCOUNTABILITIES</b></p><p><b>
Policies &amp; Procedures:</b></p><ul><li>
Adhere to all Zahrawi Policies &amp; Procedures as applicable.</li></ul><p><b>
Regulatory Affairs:</b></p><ul><li>
Ensure that Zahrawi&rsquo;s products comply with the regulations of the SFDA.</li><li>
Keep up to date with the latest changes in regulatory legislation and guidelines.</li><li>
Liaise and negotiate with regulatory authority to ensure a smooth registration process.</li><li>
Provide advice about regulations to customers/suppliers.</li><li>
Analyze product complaints and make recommendations to solve the problem and to avoid them in the future.</li></ul><p><b>
Product Classification &amp; Registration:</b></p><ul><li>
Ensure that all required documents and actions for Product Classification/Manufacturing Site Registration and Product Registration are available.</li><li>
Prepare all required documents to be submitted for Product Classification under SFDA.</li><li>
Prepare all required documents to be submitted for Manufacturing Site registration under SFDA.</li><li>
Prepare all the Dossiers to be submitted to SFDA for medical, pharmaceuticals and GSL products.</li><li>
Prepare and submit samples to SFDA for product registration completion.</li><li>
Collect all necessary documents from Supplier to submit for SFDA of products under Ghad System.</li><li>
Register reagents with restricted elements through Ghad System.</li></ul><p><b>
Importation Permits:</b></p><ul><li>
Prepare and apply for the pre-permit document as per the SFDA guidelines and verify the items being imported and the documents required.</li><li>
Apply for the MOH Narcotics and Pre-cursor Chemical permits on the SFDA website as per the specified guidelines.</li><li>
Register and submit the permits through Ghad system.</li><li>
Resubmit any permits that have not been approved and make sure all the information provided is correct and attach any new documents if required.</li><li>
Prepare weekly / monthly report regarding the rejections/ delays for SFDA importation permits and reasons related to that.</li><li>
Check and review the safety data sheet of the restricted element to prepare the required documents for obtaining MOI approval.</li></ul><p><b>
Exportation Permits:</b></p><ul><li>
Prepare the required documents necessary for obtaining SFDA approval to export medical products outside KSA.</li></ul><p><b>
Importation Rules &amp; Regulations:</b></p><ul><li>
Communicate with the existing and new suppliers regarding SFDA importation rules and policies.</li><li>
Upload on the SFDA importation system any new classifications or registration certificates.</li><li>
Ensure that all urgent request from the Sales team and suppliers are dealt with in a fast manner and ensure that all documents are in place.</li><li>
Report any deviation from SFDA guidelines of imported shipments and take the corrective and preventive action accordingly.</li><li>
Review on a regular basis the SFDA importation process of distribution agreements.</li><li>
Ensure that the SFDA license is renewed before expiry date to avoid importation disturbance.</li><li>
Segregate the imported products as per HS code in coordination with logistic team and confirm if products are SFDA regulated or not.</li><li>
Coordinate with the Procurement &amp; Logistics Team to update all the required documents in time to avoid importation rejections.</li></ul><p><b>
Audit:</b></p><ul><li>
Prepare any documentation needed for internal and external audits.</li><li>
File all documents in the corresponding files to ensure all are available and are correct.</li><li>
Evaluate the suggestions after the audit and implement them when possible.</li></ul><p><b>
Admin:</b></p><ul><li>
Assist the Warehouse Coordinators with relevant documents when requested.</li><li>
Coordinate with the Procurement team and assist them with any question they or the Suppliers may have related to SFDA importation.</li></ul><p><b>
Note: Zahrawi employees must step into other work assigned to them as business needs arise and are not limited to the above.</b></p><p><b>
REQUIREMENTS</b></p><ul><li><p><b>
Education:</b> Bachelor&rsquo;s degree (Biology/ Pharmacy/ Biomedical or Science related major is an advantage)</p></li><li><p><b>
Experience:</b> 2-3 years of relevant experience in regulatory affairs</p></li><li><b>
Job Specific Skills:</b> Effective Communication skills &amp; Good English - Time management skills - Problem Solving Skills - Good computer skills in Ms. Office (Excel&ndash; ERP/Oracle system) &ndash; Process Management skills &ndash; Detail Oriented &ndash; Knowledge about Saber System &amp; Ghad System - Knowledge in SFDA regulations.</li><li><p><b>
Additional Details:</b> Candidate should be Saudi National and based in Riyadh, KSA.</p></li></ul>
</div></div><p></p><p>Location: KSA - Riyadh
</p><p></p><p>Job Type: FULLTIME
</p><p></p><p>Job Posting Date: 03-09-2025
</p><p>Division/Department: Regulatory Affairs and Pharmacovigilance</p></div></div></div></div><p></p>

Regulatory Affairs Executive/Specialist

Perrigo

<p></p><div><p>At Perrigo, we are driven by our mission to <b><i>Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All</i></b>. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing <b><i>The Best Self-Care for Everyone</i></b>, we are the people behind the brands you trust. We are Opill&reg;, Compeed&reg;, Solpadeine&reg;, NiQuitin&reg;, ACO&reg;, and many more. <b>We Are Perrigo</b>. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.</p><p></p><p><br>
Join us on our One Perrigo journey as we evolve to win in self-care.</p><p></p><div><div><div><h2 class="jobSectionHeader"><b><br>
Description Overview</b></h2></div><div><p>
In this role you will be responsible for the hands on regulatory activities required to maintain existing commercial products, and support in making correct and timely new product applications of Perrigo products on the Turkish market. You will support to ensure compliance with the existing legislation for Medicines, Medical Devices, Biocides and Cosmetics. Another key aspect of the role will be supporting in the achievement of the overall Regulatory, Quality &amp; Safety objectives and timely realization of operational activities. In this position you collaborate closely with the Corporate Regulatory and Turkish Commercial colleagues to strive to help the customer the best.</p></div></div><div><div><h2 class="jobSectionHeader"><b>
Scope of the Role</b></h2></div><div><ul><li>
Support in the management of change by preparing applications and technical files in support of existing commercial product regulatory maintenance;</li><li>
Support in the regulatory activities on new product development (NPD), including artwork approvals, label claims and associated supporting documentation;</li><li>
Develop and approve label specifications (master text and local artwork text) in compliance with SOPs, as well as promotional materials from a regulatory perspective;</li><li>
Maintain regulatory files and data systems in compliance with SOPs;</li><li>
Represent regulatory affairs in project meetings with both Perrigo staff and external contacts;</li><li>
Follow up on changes in (inter)national regulations and legislations, and support in the interpretation, communication and implementation;</li><li>
Liaise with Corporate Regulatory, responding to regulatory queries and providing and review of registration documents as necessary for the Turkish and/or European territory;</li><li>
Support in the communication with local regulatory authorities regarding license applications and notice of change.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Experience Required</b></h2></div><div><ul><li>
University Degree in a Scientific Subject;</li><li>
Minimum of 2 years work experience within Regulatory Affairs required, within at least one of the following categories Medical Devices, Biocides, Cosmetics and Medicines;</li><li>
Excellent communicator in Turkish and English;</li><li>
Proficient computer skills esp. Microsoft (word, excel, powerpoint); experience with Veeva, TVT, Trackwise is an asset;</li><li>
Eye for detail, punctual, well organized;</li><li>
Being flexible and adaptable to change;</li><li>
Ability to support several concurrent projects/products simultaneously;</li></ul></div></div></div><p><b>
Benefits</b><br>
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.</p><p>
Find out more about <b>Total Rewards</b> at Perrigo.</p><p></p><p><b><br>
Hybrid Working Approach</b><br>
We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.</p><p></p><p><br>
We are proud to be included in the Forbes list of &quot;America's Best Employers by State 2024&quot;. Find out more <b>here</b></p><p></p><p><b><br>
Applicants please note:</b> To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.</p><p></p><p><i><br>
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo</i></p></div>

Regulatory Affairs, Associate Specialist

Lucy Electric

<div>
 Internal Job Title:
 <strong>
  Compliance Specialist
  <br/>
  <br/>
 </strong>
 Business:
 <strong>
  Lucy Switchgear Arabia Ltd
  <br/>
  <br/>
 </strong>
 Location:
 <strong>
  Dammam, Saudi Arabia
  <br/>
  <br/>
 </strong>
 Job Reference No:
 <strong>
  4244
  <br/>
  <br/>
 </strong>
 <strong>
  Job Purpose
  <br/>
  <br/>
 </strong>
 The Compliance Specialist &ndash; KSA is responsible for ensuring Lucy Electric&rsquo;s operations in Saudi Arabia comply with applicable laws, regulatory requirements, and internal governance standards. Acting as a critical link between government affairs and corporate compliance teams, the role leads program implementation, monitors regulatory developments, and coordinates cross-functional efforts to maintain a robust, locally tailored compliance framework.
 <br/>
 <br/>
 <strong>
  Job Context
  <br/>
  <br/>
 </strong>
 Operating within the regulated industrial and utility sector, Lucy Switchgear Arabia Ltd. manufactures medium-voltage switchgear and distribution solutions for infrastructure projects across Saudi Arabia. The Compliance Specialist &ndash; KSA ensures regulatory alignment across manufacturing, commercial, and operational functions, requiring 5&ndash;10 years&rsquo; experience in compliance management, policy implementation, audit preparedness, and internal controls.
 <br/>
 <br/>
 <strong>
  Job Dimensions
  <br/>
  <br/>
 </strong>
 The role reports to the General Manager and interfaces with regional and global compliance and wider business teams. It supports Lucy Electric&rsquo;s broader compliance initiatives, engages regularly with KSA government and regulatory authorities, and collaborates cross-functionally&mdash;including with Quality, Contracts, Operations, and Supply Chain&mdash;to promote a culture of compliance and operational discipline.
 <br/>
 <br/>
 <strong>
  Key Accountabilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Oversee all aspects of external regulatory compliance across Lucy Electric&rsquo;s KSA operations, serving as the point of contact for submissions, inspections, and coordination with government bodies
  </li>
  <li>
   Support and embed Lucy Electric&rsquo;s internal compliance framework within local manufacturing and commercial operations, aligned with global governance standards
  </li>
  <li>
   Maintain the Risk &amp; Opportunity (R/O) Register, gathering insights from all functions to surface priority risks and opportunities; review top 10 items regularly with the Site General Manager to inform planning
  </li>
  <li>
   Assist the Site GM in managing the Compliance Register, ensuring cross-functional inputs are consolidated, gaps analysed, and board-level reporting is prepared
  </li>
  <li>
   Track changes in local regulations, assess business impact, and coordinate procedural updates with affected teams
  </li>
  <li>
   Lead compliance audits and readiness checks; ensure complete documentation and corrective action tracking in accordance with audit requirements
  </li>
  <li>
   Collaborate with internal departments to ensure regulatory compliance is integrated into daily operations and project execution
  </li>
  <li>
   Conduct compliance training and awareness programs to foster engagement and accountability across the workforce
  </li>
  <li>
   Escalate unresolved or high-risk compliance issues to legal and global compliance functions and support documentation and remediation processes
   <br/>
   <br/>
  </li>
 </ul>
 Deliver structured compliance reporting to senior management, covering performance trends, key risk indicators, and governance alignment.
 <br/>
 <br/>
 <strong>
  Qualifications, Experience &amp; Skills
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor&rsquo;s degree in Engineering, Business Administration, Law, or related field; certifications in compliance or regulatory affairs preferred
  </li>
  <li>
   5&ndash;10 years&rsquo; experience in regulatory compliance within industrial manufacturing or infrastructure environments, preferably in KSA
  </li>
  <li>
   Proven ability to interpret and apply local regulations and engage effectively with government and regulatory bodies across the Kingdom
  </li>
  <li>
   Strong understanding of corporate governance, internal controls, and compliance frameworks in technical operational settings
  </li>
  <li>
   Skilled in managing compliance registers and documentation, performing gap analyses, and preparing board-facing summaries
  </li>
  <li>
   Experience coordinating audits and regulatory reviews, with an ability to align procedures across departments
  </li>
  <li>
   Effective communicator capable of influencing senior stakeholders and collaborating within matrixed environments
  </li>
  <li>
   Track record of leading compliance awareness and training initiatives across diverse teams
  </li>
  <li>
   Analytical, detail-oriented, and experienced in navigating multi-site or international organizational structures
   <br/>
   <br/>
  </li>
 </ul>
 Good knowledge of ISO requirements ( 9001 ,14001 ,45001,..Etc.)
 <br/>
 <br/>
 <strong>
  Behavioural Competencies
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Takes ownership of deliverables and meets compliance deadlines with precision
  </li>
  <li>
   Build trust and influence across departments and senior leadership
  </li>
  <li>
   Communicates complex requirements clearly and adapts to varied audiences
  </li>
  <li>
   Anticipates risks and proactively drives resolution and improvement
  </li>
  <li>
   Collaborates across functions to integrate compliance into daily workflows
  </li>
  <li>
   Promote awareness and understanding through training and engagement
  </li>
  <li>
   Maintains transparency, consistency, and alignment with governance standards
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Does this sound interesting? We would love to hear from you. Our application process in quick and easy. Apply today!
 </strong>
</div>


Compliance Specialist

RECH INTERNATIONAL

<p><b>Regulatory Affairs Officer - Karachi</b></p><p>The Regulatory Affairs Officer ensures compliance with <b>DRAP regulations</b> for licensing, registration, and marketing of medical devices, acting as the key link between Rech International and regulatory authorities.</p><p><b>Job Type: Full time - Onsite</b></p><p><b>Working hours: 9am - 6pm</b></p><p><b>Working Days: Monday - Saturday</b></p><p><b>Market Competitive Salary &amp; Benefits</b></p><p><b>Key Responsibilities:</b></p><ul><li>Prepare, submit, and follow up on <b>DRAP registration/notification dossiers.</b></li><li>Manage licensing of medical devices (Orthopedic Implants, OMF, Neuro, Spine, Knee &amp; Hip Joints).</li><li>Liaise with DRAP officials and internal stakeholders to ensure timely approvals.</li><li>Monitor and implement changes in DRAP regulations, keeping records updated.</li><li>Ensure compliance of product portfolio with DRAP guidelines and legislation.</li><li>Provide regulatory input, reporting, and support for internal teams and external partners.</li></ul><p><b>Qualifications &amp; Experience:</b></p><ul><li>Bachelors degree in Sciences; Masters preferred.</li><li>3-4 years experience in <b>Regulatory Affairs with DRAP submissions</b>.</li><li>Strong knowledge of DRAP laws and guidelines for medical devices.</li><li>Proficiency in MS Office &amp; Google Apps.</li><li>Excellent communication, analytical, and documentation skills.</li></ul><p>Job Type: Full-time</p><p>Pay: Rs40,000.00 - Rs80,000.00 per month</p><p>Application Question(s):</p><ul><li>What is your current salary ?</li><li>How soon can you join?</li><li>What is your salary expectation?</li><li>Do you have experience of DRAP?</li></ul><p>Education:</p><ul><li>Bachelor's (Required)</li></ul><p>Experience:</p><ul><li>Regulatory affairs: 2 years (Required)</li></ul><p>Work Location: In person</p>

Regulatory Affairs Executive

PRANIC DRUG STORE LLC

<p><b>Job Description</b><br/>We are seeking a <b>Regulatory Pharmacist</b> with strong experience in regulatory affairs and pharmacovigilance to join our team. The candidate must be fluent in <b>Arabic and English</b> and ensure compliance with all regulatory standards throughout the product lifecycle.</p><p><b>Responsibilities</b></p><ul><li>Prepare, review, and submit regulatory documents to authorities.</li><li>Respond to regulatory queries and maintain compliance with regulatory requirements.</li><li>Support product registration, renewals, and variations.</li><li>Ensure pharmacovigilance reporting and documentation are completed accurately and on time.</li><li>Coordinate with internal teams to meet regulatory deadlines.</li></ul><p><b>Requirements</b></p><ul><li>Bachelor&rsquo;s degree in Pharmacy with valid license/eligibility (MOH).</li><li><b>Pharmacovigilance certificate</b> (mandatory).</li><li>Minimum 1 <b>years of experience</b> in regulatory affairs.</li><li>Strong knowledge of regulatory standards and procedures.</li><li><b>Fluency in Arabic (mandatory)</b> and English.</li><li>Preferably with <b>own visa</b>.</li><li>Valid UAE Driving Licence (preferred).</li></ul><p><b>Job Type:</b> Full-time<br/><b>Location:</b> United Arab Emirates</p><p>Job Type: Full-time</p><p>Pay: AED3,000.00 - AED10,000.00 per month</p>

Regulatory Pharmacist (with Pharmacovigilance Certificate)

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