regulatory affairs specialist

Stellar Hunters

<div><h4 class="jobSectionHeader">Job Summary</h4>
We are seeking a detail-oriented and knowledgeable Regulatory Affairs Specialist to ensure that products, processes, and operations comply with applicable regulatory requirements. The successful candidate will support product registrations, maintain regulatory documentation, and liaise with regulatory authorities to ensure timely approvals and ongoing compliance.
This role requires strong understanding of regulatory frameworks, documentation accuracy، and the ability to work cross-functionally in a fast-paced, compliance-driven environment.<h4 class="jobSectionHeader">
Key Responsibilities</h4><h5 class="jobSectionHeader">
Regulatory Submissions &amp; Approvals</h5><ul><li>
Prepare, review, and submit regulatory dossiers and documentation to relevant authorities (e.g., SFDA or other applicable bodies).</li><li>
Track and manage product registration timelines, renewals, and approvals.</li></ul><h5 class="jobSectionHeader">
Compliance &amp; Documentation</h5><ul><li>
Ensure all products and processes comply with local and international regulatory requirements.</li><li>
Maintain up-to-date regulatory documentation, technical files, and records.</li></ul><h5 class="jobSectionHeader">
Regulatory Intelligence</h5><ul><li>
Monitor changes in regulations and guidelines and assess their impact on the business.</li><li>
Communicate regulatory updates to internal stakeholders and recommend necessary actions.</li></ul><h5 class="jobSectionHeader">
Cross-functional Collaboration</h5><ul><li>
Work closely with R&amp;D, Quality, Manufacturing, and Marketing teams to ensure compliance throughout the product lifecycle.</li><li>
Support new product development by providing regulatory guidance and requirements.</li></ul><h5 class="jobSectionHeader">
Audit &amp; Inspection Support</h5><ul><li>
Support internal and external audits, inspections, and regulatory inquiries.</li><li>
Ensure readiness and proper documentation for compliance reviews.</li></ul><h5 class="jobSectionHeader">
Labeling &amp; Claims Review</h5><ul><li>
Review product labeling, packaging, and marketing materials to ensure regulatory compliance.</li><li>
Ensure all product claims are supported and aligned with regulatory standards.</li></ul><h5 class="jobSectionHeader">
Continuous Improvement</h5><ul><li>
Identify opportunities to improve regulatory processes, documentation systems, and submission workflows.</li></ul><h4 class="jobSectionHeader">
Required Qualifications - Skills &amp; Experience</h4><ul><li>
Bachelor&rsquo;s degree in Pharmacy, Life Sciences, Chemistry, or a related field.</li><li>
2&ndash;5 years of experience in regulatory affairs, preferably within pharmaceutical, medical device, or FMCG industries.</li><li>
Strong knowledge of regulatory frameworks and submission processes.</li><li>
Experience with product registration and regulatory documentation.</li><li>
Excellent attention to detail and organizational skills.</li><li>
Strong communication and stakeholder management skills.</li></ul><h4 class="jobSectionHeader">
Preferred Qualifications</h4><ul><li>
Experience with Saudi regulatory bodies such as SFDA.</li><li>
Familiarity with GCC or international regulatory requirements.</li><li>
Experience with electronic submission systems and regulatory databases.</li><li>
Certification or training in regulatory affairs is a plus.</li></ul><h4 class="jobSectionHeader">
Work Environment &amp; Compensation</h4><ul><li>
Full-time position with an onsite model.</li><li>
Competitive salary commensurate with experience and a comprehensive benefits package, including health insurance, retirement plan options, and paid time off.</li><li>
Opportunities for professional development, training, and certification support; clear paths for career growth within IT and cross-functional teams.</li><li>
Inclusive culture that values diversity, equity, work-life balance, and employee well-being.</li></ul></div>

Regulatory Affairs Specialist

Air Products

<div>
 At Air Products, our purpose is to bring people together to reimagine what&rsquo;s possible, collaborate and innovate solutions to the world&rsquo;s most significant energy and environmental sustainability challenges. Grow with us as we embark on building tomorrow together by being the safest, most diverse and most profitable industrial gas company in the world.
 
 
 
 Reimagine What&rsquo;s Possible
 
 
 
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 Liaise with government entities (GAFI, SCzone, Customs and IDA etc..) and service providers, to make sure that we are compliant with local requirements.
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 Manage all licensing process requirements, environmental, operating, etc, and maintaining updates for the same.
 </li>
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 Liaise with functional departments to ensure that all legal documents, CR, tax card, etc, records are issued on time, and keep track of renewal dates, including proper filing and archiving.
 </li>
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 Maintain and organize company records, including files, databases, and correspondence, ensuring confidentiality and security.
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 Support projects team in local admin requirements from initiation to completion.
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 Coordinate with carrier and forwarders to ensure flawless shipping of equipment, and manages the Customs portal, while maintaining effective communication with project and business team&rsquo;s, to update them on shipment statuses..
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 Prepare shipping documentation, shipment invoices, and customs forms as required.
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 Track and resolve shipping-related issues, including delays and damages in coordination with the business teams.
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 Build and maintain relationships with vendors, suppliers, and logistics partners.
 </li>
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 Utilize shipping software/ portal to track shipments efficiently.
 </li>
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 Managing local purchasing requests &amp; supplies, stationery and equipment, furniture, etc. for the entire staff in accordance with company purchasing policies and budgetary restrictions.
 </li>
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 Manage overall company transportation services for staff &amp; visitors when needed to ensure smooth workflow and quality service level.
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 Support accounting teams in monthly closing by ensuring that all the transactions are properly posted on time in company ERP.
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 Laise with functional departments to ensure that all the vendors invoices are paid on time.
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 Coordinate with tax consultant for Filing the taxation.
 </li>
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 Responsible to receive and submit all the banking documents on behalf of the company.
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 Assist with budgeting and expense tracking for projects and shipping activities.
 </li>
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 Maintain effective communication with business team&rsquo;s, to update them on shipment statuses.
 </li>
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 Build and maintain relationships with vendors, suppliers, and logistics partners.
 </li>
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 Responsible for the forecasting and budgeting process for all Admin related items.
 
 
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 </ul>
 We are the world&rsquo;s largest hydrogen producer with over 80 years of industrial gas experience. We are hydrogen and industrial gas experts delivering safe, end-to-end solutions, investing in real, clean energy projects at scale, and driving the industry forward to generate a cleaner future.
 
 
 At Air Products, we work in an environment where we put safety first, diversity is essential, inclusion is our culture, and each person knows they belong and matter. To learn more, visit About Air Products.
 
 
</div>

Nawy

<div>
 The Governmental Affairs Specialist at Nawy Real Estate will play a crucial role in engaging with governmental bodies and regulatory agencies. This position entails monitoring policy developments, advocating for the company's interests, and ensuring compliance with relevant laws and regulations.
 
 
 
 Key Responsibilities:
 
 
 
 <ul>
 <li>
 Monitor and analyze legislative and regulatory developments that may impact Nawy's operations
 </li>
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 Develop and maintain strong relationships with governmental officials, industry associations, and other stakeholders
 </li>
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 Prepare reports and position papers to inform senior management on key issues impacting the business
 </li>
 <li>
 Coordinate with internal teams to ensure consistent messaging and strategic alignment in advocacy efforts
 </li>
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 Assist in the development and execution of governmental affairs strategies and initiatives that align with Nawy's business goals
 </li>
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 Represent Nawy at meetings, conferences, and public hearings to advocate for policies beneficial to the company
 </li>
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 Facilitate communication between Nawy and various governmental entities
 </li>
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 Prepare advocacy materials, policy briefs, and presentations for stakeholders
 
 
 </li>
 </ul>
 
 Requirements
 
 
 
 
 Requirements:
 
 
 
 <ul>
 <li>
 Bachelor's degree in Political Science, Law, Public Affairs, or a related field
 </li>
 <li>
 2-4 years of experience in governmental affairs, public policy, or a similar role, preferably within the real estate industry
 </li>
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 Strong understanding of the legislative process and governmental structures
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 Excellent communication and interpersonal skills, with the ability to build relationships with a variety of stakeholders
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 Proven ability to analyze policy issues and communicate complex ideas effectively
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 Strong organizational and time management skills, with the ability to manage multiple tasks concurrently
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 Proficiency in Microsoft Office Suite and familiarity with CRM systems
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 Ability to work independently and collaboratively within a team
 </li>
 </ul>
</div>

Governmental Affairs Specialist

Nawy Real Estate

<div>The Governmental Affairs Specialist at Nawy Real Estate will play a crucial role in engaging with governmental bodies and regulatory agencies. This position entails monitoring policy developments, advocating for the company's interests, and ensuring compliance with relevant laws and regulations.
Key Responsibilities:<ul>
<li>Monitor and analyze legislative and regulatory developments that may impact Nawy&rsquo;s operations.</li>
<li>Develop and maintain strong relationships with governmental officials, industry associations, and other stakeholders.</li>
<li>Prepare reports and position papers to inform senior management on key issues impacting the business.</li>
<li>Coordinate with internal teams to ensure consistent messaging and strategic alignment in advocacy efforts.</li>
<li>Assist in the development and execution of governmental affairs strategies and initiatives that align with Nawy's business goals.</li>
<li>Represent Nawy at meetings, conferences, and public hearings to advocate for policies beneficial to the company.</li>
<li>Facilitate communication between Nawy and various governmental entities.</li>
<li>Prepare advocacy materials, policy briefs, and presentations for stakeholders.</li> 
</ul> 
 
Requirements 
Requirements:<ul>
<li>Bachelor's degree in Political Science, Law, Public Affairs, or a related field.</li>
<li>2-4 years of experience in governmental affairs, public policy, or a similar role, preferably within the real estate industry.</li>
<li>Strong understanding of the legislative process and governmental structures.</li>
<li>Excellent communication and interpersonal skills, with the ability to build relationships with a variety of stakeholders.</li>
<li>Proven ability to analyze policy issues and communicate complex ideas effectively.</li>
<li>Strong organizational and time management skills, with the ability to manage multiple tasks concurrently.</li>
<li>Proficiency in Microsoft Office Suite and familiarity with CRM systems.</li>
<li>Ability to work independently and collaboratively within a team.</li></ul></div>

Vitra Health

<div>Vitra Health is a mission-driven healthcare organization committed to improving the quality of life for individuals and families across Massachusetts. Through innovative home- and community-based services, Vitra supports aging adults, people with disabilities, and individuals with complex care needs&mdash; supported by a Nurse, and Case Manager, Vitra ensures clients receive compassionate, personalized, and dignified care.
To help share our mission and expand our community impact, Vitra Health is seeking a Compliance Specialist who is passionate about community engagement and helping people access the care and resources they deserve.
The Opportunity
As a Clinical Compliance Specialist with Vitra Health's, you will support the day-to-day operations of the Compliance Department by helping maintain regulatory and accreditation standards across the organization. The role supports clinical quality &amp; compliance by engaging in monitoring and developing activities to enhance healthcare delivery standards.
This role plays a key part in promoting a culture of compliance by ensuring timely communication, accurate documentation, and effective follow-through on compliance initiatives. The ideal candidate is mission-minded, detailed oriented, highly organized, and able to maintain the confidentiality of sensitive information.
Key Responsibilities
Compliance Program Support:
<ul><li>Support the Compliance Officer and Compliance Manager in implementing and maintaining the organization's compliance program and compliance workplan
</li><li>Monitor regulatory changes and assist with updates to policies, procedures, and internal controls
</li><li>Maintain compliance documentation, tracking tools, and audit logs</li><li>
Support internal and external audits, reviews, and regulatory inquiries</li><li>
Track and assist with preparing external compliance reports to regulators, payers, and accreditation bodies.
</li><li>Lead or coordinate compliance-related tasks related to healthcare delivery and field staff including engaging with clients to check quality of care coordination and client visits.
</li><li>Monitoring, Risk Assessment &amp; Review:</li><li>
Execute risk-based monitoring across clinical documentation and service delivery</li><li>
Identify and prioritize regulatory risk areas within AFC, GAFC, and ADH programs
</li><li>Perform periodic and targeted reviews of medical records
</li><li>Maintain clear, organized workpapers to support review activities
</li><li>Performs visits (remote and onsite) to ensure continuity of service and documentation are aligned with compliance and quality standards</li><li>
Engage with caregiver to assess effectiveness and presence of required education</li><li>
Serves as educator to field staff to assess risk and gaps in required education</li><li>
Periodically review care teams files to ensure alignment with program requirements</li><li>
Monitors qualitative and quantitative requirements of client visits and caregiver logs</li><li>
Reviews care teams compliance requirements in alignment with Vitra's compliance plan</li><li>
Document and communicate findings in clear, actionable reports to compliance team and ops management
</li><li>Assess and classify issues based on risk and regulatory impact
</li><li>Escalate significant concerns in accordance with established protocols
</li><li>Maintain training records and assist in developing or updating training materials.
</li><li>Support cross-functional teams in preparing for audits and responding to surveyor requests
</li><li>Foster culture of customer service and commitment to quality care.</li><li>
Serve as a brand ambassador for Vitra reflecting our vision, mission, and values.</li><li>
Show genuine interest and compassion for the communities we serve and commitment to the diversity of our clients and team members.</li></ul>
What we are looking for:
<ul><li>Degree in nursing required. Active RN license in the state of Massachusetts.
</li><li>Certifications in one or more of the following preferred: Certified in Healthcare Compliance (CHC) Certified Professional Coder (CPC), Certified Coding Specialist (CCS), or willingness to obtain in 6 months.</li><li>
Minimum of two years of experience in healthcare compliance, regulatory affairs, or a similar role required.
</li><li>Experience reviewing documentation, claims, or billing processes in a regulated environment</li><li>
Familiarity with healthcare regulations including HIPAA, CMS, NCQA, and OIG guidelines strongly preferred.</li><li>
Experience with electronic medical records, learning management systems, compliance tracking tools, or risk management platforms preferred.
</li><li>Strong command of Microsoft Excel and Microsoft PowerPoint.</li><li>
Strong organizational, analytical, and communication skills.
</li><li>Ability to manage confidential and sensitive information with integrity and discretion.
</li><li>Potential for occasional travel between office locations, especially during external audits or inspections.
</li></ul>Work Environment and Physical Requirements
<ul><li>Office-based work in a clean well-lit environment with fluctuating temperatures near others.</li><li>
Client-facing field staff and community liaisons require frequent travel to client homes or community settings; ability to drive safely; work in client homes may involve varying temperatures, odors, allergens, pets, and other environmental factors.</li><li>
Requires substantial periods of repetitive work utilizing a computer, monitor, keyboard, and mouse.</li><li>
Requires lifting and carrying equipment and supplies weighing up to 35 pounds; requires pushing and pulling equipment and supplies weighing up to 35 pounds; requires walking and standing; requires frequent sitting more than 75% of the workday; requires the ability to negotiate stairs; requires visual acuity and manual dexterity to operate equipment.</li></ul>
Perks and Benefits:
<ul><li>Employer sponsored health Insurance with a generous employer match.</li><li>
Dental and Vision Benefits.</li><li>
Supplemental Benefits</li><li>
Life, Accident, Critical Illness and Disability Insurance.</li><li>
401K with a 5% company match.</li><li>
Accrued Paid-Time-Off.</li><li>
Ten company paid holidays.</li><li>
Wellness Benefits.</li><li>
Tuition Reimbursement.</li><li>
Supportive team structure and company culture with a focus on work/life balance.</li></ul>
Vitra Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.</div>

Clinical Compliance Specialist

Ghrasa Laboratory

We Are Hiring: DRAP Regulatory Affairs OfficerWe are looking for an experienced and detail-oriented DRAP Regulatory Affairs Officer to join our growing team and ensure full compliance with regulatory requirements for medical and laboratory equipment in Pakistan.Key Responsibilities:<ul><li>Manage product registrations with DRAP (Class A, B, C &amp; D devices)</li><li>Ensure compliance with DRAP rules, guidelines, and documentation</li><li>Prepare and submit regulatory dossiers and technical files</li><li>Liaise with DRAP officials and regulatory bodies</li><li>Monitor regulatory updates and implement changes internally</li><li>Support marketing team with compliant product claims and advertisements</li></ul>Requirements:<ul><li>Bachelor&rsquo;s/Master&rsquo;s in Pharmacy or relevant field</li><li>3&ndash;5 years of experience in DRAP regulatory affairs</li><li>Strong knowledge of DRAP regulations and medical device classification</li><li>Experience with product registration and licensing processes</li><li>Excellent documentation and communication skills</li></ul>What We Offer:<ul><li>Competitive salary package with other company benefits</li><li>Career growth in a rapidly expanding company</li><li>Professional and compliance-driven work environment</li></ul>Apply Now: Send your CV to: HR@ghrasa.com Whatsapp: 0317-3172913Only shortlisted candidates will be contactedWork Location: In person

DRAP Regulatory Affairs Officer

ASG management services LLC

Must have MOH LicenseResponsibilities of the Regulatory Affairs Pharmacist (Pharmacist in Charge / PIC)Regulatory Responsibilities<ul><li>Ensure compliance with UAE pharmaceutical regulations and Federal Law related to pharmacy practice.</li></ul><ul><li>Maintain compliance with MOHAP / Emirates Drug Establishment (EDE) licensing conditions.</li></ul><ul><li>Ensure implementation of Good Storage and Distribution Practice (GSDP/GDP).</li></ul><ul><li>Act as the official contact person with health authorities. Operational Responsibilities</li></ul><ul><li>Supervise receipt, storage, and distribution of pharmaceutical products.</li></ul><ul><li>Ensure products are registered and approved before distribution.</li></ul><ul><li>Verify product quality, expiry dates, and batch numbers. Quality Responsibilities</li></ul><ul><li>Establish and implement Quality Management System (QMS).</li></ul><ul><li>Approve and maintain Standard Operating Procedures (SOPs).</li></ul><ul><li>Manage deviations, CAPA, and quality investigations. Warehouse Control Ensure correct storage conditions: &bull; Temperature &bull; Humidity</li></ul><ul><li>Segregation of products</li></ul><ul><li>Oversee cold chain management. Documentation Maintain records including:</li></ul><ul><li>Batch traceability</li></ul><ul><li>Distribution records</li></ul><ul><li>Temperature monitoring</li></ul><ul><li>Product complaints</li></ul><ul><li>Recall records Inspection &amp; Audit</li></ul><ul><li>Prepare the facility for MOHAP/EDE inspections.</li></ul><ul><li>Address inspection observations and implement corrective actions. Product Safety</li></ul><ul><li>Manage product complaints.</li></ul><ul><li>Implement product recall procedures if necessary.</li></ul>Job Type: Full-timePay: Up to AED4,500.00 per monthWork Location: In person

Regulatory Affairs Pharmacist

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