regulatory compliance specialist

Praxis Packaging Solutions

<div><h2 class="jobSectionHeader">Overview
</h2><div><div><div>Responsible for compliance with the requirements of 21CFR Parts 110/111 and 210/211. This position works closely with the Quality Managers and other internal department managers and supervisors at Praxis to ensure Quality Assurance oversite, reviews approvals and releases all assigned products throughout the life cycle of the batch from receipt of PO to reporting PO. This position collaborates with Praxis Leadership and partners to educate, audit and enforce all applicable cGMPs, customer requirements, and Praxis QMS documents. This position works with all supervision and employees to ensure that cGMPs and Praxis SOPs, policies and work instructions are being followed.
</div></div></div><h2 class="jobSectionHeader">Responsibilities
</h2><div><div><div><ul><li>Manages the content and executional effectiveness of the QA Programs, Systems and compliance with all regulatory requirements associated with Praxis.</li><li>
Ensures all Regulatory licensing is maintained, current and compliant per required standards.</li><li>
Manages Internal and External Audit programs.</li><li>
Responsible for operational and facility integrity they relate to facility food safety, pest control, sanitation, cleaning validation and environmental monitoring. Works with company leaders and employees to ensure cGMP, CFR 110, CFR 211 and Praxis Quality Management System compliance.</li><li>
Responsible for internal Quality Audits and Supplier Audits.</li><li>
Manages regulatory filing for Praxis
</li><li>Ensures that Food Safety, production process, cleaning and general Sanitation procedures are established and performed as planned and necessary.</li><li>
Manages Food Defense Plan, including Allergen control and employee education. Establishes and monitors CCPs (critical control points) for HACCP.</li><li>
Oversees all cleaning, sanitation and environmental monitoring (swabbing) activities &ndash; to include communication with partner departments and customers. Improves processes where necessary.</li><li>
Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.</li><li>
Manages Pest Control programs, processes, reporting, records, corrective/preventive actions, and approved contractors (to include their selection and performance review).</li><li>
Ensures insect lights and glue boards are maintained, as directed.</li><li>
Monitors REES system for temperature and humidity performance vs. specified ranges and customer requirements. Takes necessary corrective and/or preventive actions.</li><li>
Monitors and ensures compliance of facility AIR and WATER quality performance testing (and/or vendors), according to Preventive Maintenance schedule.</li><li>
Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints, review and approve deviations and change controls.
</li><li>Performs and Manages APR process and compliance.</li><li>
Manages the QA review of Facility and Equipment documentation.</li><li>
Assist with QA projects.</li><li>
Responsible for adherence to all Company policies and procedures.
</li><li>Works to improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions.</li><li>
Supports a diverse workforce.</li><li>
Addresses complaints and problems, elevates to Leadership when needed.
</li><li>Ensures proper PPE&rsquo;s and Safety procedures are followed.</li><li>
Instill a sense of quality in through modeled quality behaviors and mindset.</li><li>
Flexibly works other shifts, shifts maybe 8, 10 or 12 hours as needed.</li><li>
Responsible for management level of responsibility for reviews and approvals as appropriate.</li></ul>
</div></div></div><h2 class="jobSectionHeader">Qualifications
</h2><div><div><div><ul><li>Bachelor&rsquo;s degree, required or equivalent combination.</li><li>
3-5 years Quality experience required.</li><li>
Supervision experience preferred.</li><li>
Quality System Management (QSM) system design and evaluation, required</li></ul></div></div></div></div>

Quality Regulatory Compliance Specialist

Amazon

<div>
 
 Description
 
 
 
 Compliance Specialist &ndash; Quick Commerce
 
 
 Amazon.com strives to be Earth's most customer-centric company where people can find and discover virtually anything they want to buy online. By giving customers more of what they want - low prices, vast selection, and convenience - Amazon.com continues to grow and evolve as a world-class e-commerce platform. Amazon's evolution from Web site to e-commerce partner to development platform is driven by the spirit of innovation that is part of the company's DNA. The world's brightest technology minds come to Amazon.com to research and develop technology that improves the lives of shoppers and vendors around the world.
 
 
 We have an opportunity for an highly motivated individual to join us in our Quick Commerce in Egypt as a Compliance Specialist for multiple tasks related to municipalities, civil defense, and service providers licenses and permits. 60% travel within the country is expected.
 
 
 
 Key Responsibilities / Deliverables
 
 
 
 Assist compliance lead in managing Amazon Now building and operation compliance to authorities&rsquo; requirements, by ensuring business set up for new launches, timely tracking, reporting, and resolution of regulatory requirements across the country in collaboration with wider AMET markets. The country Compliance Specialist role will:
 
 
 <ul>
 <li>
 Government authorities liaison, including and not limited to Economic Department, Municipalities, Civil Defense, and service providers to issue licenses and permits within an expedited timeline.
 </li>
 <li>
 Compliance permits tracking, monitoring and reporting status to leaders.
 </li>
 <li>
 Effective stakeholder management including consultants, contractors, vendors and internal business functions to ensure permits are obtained and renewed in timely manner.
 </li>
 <li>
 Escalation management for delayed or high-priority permits.
 </li>
 <li>
 Contribute to permits renewal process optimization, digitalization, standardization and improvement across the country.
 
 
 </li>
 </ul>
 
 Basic Qualifications
 
 
 
 <ul>
 <li>
 2+ years of working directly with government officials and regulatory bodies experience
 </li>
 <li>
 Experience with high-level negotiation and successful internal and external relationship management
 </li>
 <li>
 Experience in problem solving and delivering results
 </li>
 <li>
 Bachelor's degree in Engineering or Business Administration or a related field
 </li>
 <li>
 Native Arabic speaker
 
 
 </li>
 </ul>
 
 Preferred Qualifications
 
 
 
 <ul>
 <li>
 Speak, write, and read fluently in English
 
 
 </li>
 </ul>
 Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you&rsquo;re applying in isn&rsquo;t listed, please contact your Recruiting Partner.
 
 
 
 
 Company
 
 - Souq.com for E-Commerce LLC - G32
 
 
 Job ID: A3108982
</div>

Compliance Specialist - Engineering, Quick Commerce

Strides Pharma Inc

<div>POSITION: Process Engineer 
DUTIES:<ul><li>Lead and execute lifecycle activities from start to end for solid oral dosage, liquid, powder filling, soft gel and semi solid form manufacturing including evaluation, validation, scale up, and lifecycle changes.</li><li>Analyze statistical data from qualification, product or functional specifications to determine conformance with standards and established quality requirements.</li><li>Assist with on-site transfer projects and product scale-up activities</li><li>Review and approve protocols that challenge the critical parameters.</li><li>Write and execute experimental and validation protocols as per related SOPs and assure that acceptance criterion related to experimental and validation protocols are met.</li><li>Write and execute experimental and validation reports as per related SOPs and assure that acceptance criterion related to experimental and validation reports are met.</li><li>Assist with initiating change control for new products, site transfer products and changes related to the process improvement with appropriate justification.</li><li>Lead investigations, write investigation reports with appropriate scientific understanding, as required upon failures to meet protocol acceptance criteria.</li><li>Author and review investigation reports, protocols, batch records and CMC documentation.</li><li>Lead projects by use of appropriate project management tools, provide timely updates to management on the status of various projects.</li><li>Lead and execute material changes, process changes and cost reduction projects.</li><li>Provide technical training and assistance to others.</li><li>To develop, execute, and oversee cleaning validation protocols for pharmaceutical solid, semi solid, liquid, cream and gel equipment and processes</li></ul> 
REQUIREMENTS: BS in Pharmacy, Pharmaceutical Science, Chemical Engineering or other related fields and 60 months experience as a as a Process Engineer, Chemical Engineer, Regulatory Compliance Specialist or related
OR
MS in Pharmacy, Pharmaceutical Science, Chemical Engineering or other related fields and 36 months experience as a as a Process Engineer, Chemical Engineer, Regulatory Compliance Specialist or related 
Hours: 40 hours a week, 9:00 a.m. to 5:00 p.m.
Salary: $110000 to 130000 base salary/year + std company benefits
Job site: 1 Ram Ridge Road, Chestnut Ridge, NY 10977</div>

Process Engineer

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.
 
 &nbsp;
 
 
 
 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 - Ensure all products meet the Egyptian regulations
 </li>
 <li>
 Product Registration - Prepare, submit, and manage dossiers for new drugs, renewals, and variations, guiding approvals from start to finish
 </li>
 <li>
 Compliance Monitoring - Stay ahead of evolving regulations, advising internal teams on critical updates to maintain full compliance
 </li>
 <li>
 Labeling &amp; Packaging Review - Ensure all pharma labeling, packaging, and promotional materials adhere to regulatory standards
 </li>
 <li>
 Cross-Functional Collaboration - Partner with R&amp;D, QA, Manufacturing, and Marketing to embed regulatory requirements at every stage
 
 
 </li>
 </ul>
 
 
 
 
 
 Requirements
 
 
 
 
 <ul>
 <li>
 Bachelor'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) - essential for global collaboration
 </li>
 <li>
 Detail-oriented, proactive, and eager to grow in a dynamic regulatory landscape
 </li>
 </ul>
</div>

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>

<div>
 
 Job Description
 
 
 
 
 
 WHAT YOU'LL DO
 
 
 
 
 
 As the Compliance Specialist you ensure that the business goals and actions comply with all applicable laws, rules, regulations, statutory orders, notifications etc. You will be primarily responsible for setting requirements and routines for all products sold by the H&amp;M group, in line with legislation and product safety. You will be required to research and find regulatory information concerning product safety and legal requirements for existing and new products. By supporting several parts of our business with your expertise, you will contribute to the overall customer experience.
 
 
 
 
 Key Responsibilities :
 
 
 
 <ul>
 <li>
 Evaluating the potential impact of current and future legal and regulatory environment for existing and new products of the Company
 </li>
 <li>
 Researching legal requirements impacting the business in specific to existing and new products of the Company.
 </li>
 <li>
 Monitoring existing legal requirements via regular audits and collaborating with relevant stakeholders to drive the required changes.
 </li>
 <li>
 Transforming complex regulatory requirements into user-friendly information and guidelines to enable compliance.
 </li>
 <li>
 Evolving robust legal and compliance SOPs for the organization
 </li>
 <li>
 Cooperate, support and train colleagues and other stakeholders to reach desired results.
 </li>
 <li>
 Dealing with various statutory, regulatory, government and judicial authorities for seeking various approvals, permissions, registrations, licenses etc. Training the stakeholders on various legal and compliance aspects.
 </li>
 <li>
 Supporting the business in driving and achieving its legal and compliance goals in day-to-day operations;
 </li>
 <li>
 Other legal support as per business needs.
 </li>
 </ul>
 
 Please click here for complete role description
 
 
 
 
 
 WHO YOU ARE
 
 
 
 
 
 COMPETENCIES:
 
 
 
 <ul>
 <li>
 A formal education within Legal curriculum is mandatory , LLB or LLM. With at least 5 years of working experience preferable in Retail Regulatory space.
 </li>
 <li>
 Sound understanding of the following areas of law &ndash; Legal Metrology. Drugs and Cosmetics Act, Commercial laws etc.
 </li>
 <li>
 Ability to handle multiple matters concurrently
 </li>
 <li>
 Able to work well both independently and as part of a team.
 </li>
 <li>
 Able to communicate well and work in a cross-functional team to achieve common goals.\
 </li>
 <li>
 You have a strategic and analytical mindset with strong planning and prioritizing skills that blends with legal and business needs.
 </li>
 </ul>
 
 Please click here for complete role description
 
 
 
 
 
 WHO WE ARE
 
 
 &ZeroWidthSpace;&ZeroWidthSpace;
 
 
 
 
 
 
 
 H&amp;M Group is a global company of strong fashion brands and ventures. Our goal is to prove that there is no compromise between exceptional design, affordable prices, and sustainable solutions. We want to liberate fashion for the many, and our customers are at the heart of every decision we make.&ZeroWidthSpace; &ZeroWidthSpace;
 
 
 
 
 We are made up of thousands of passionate and talented colleagues united by our shared culture and values. Together, we want to use our power, our scale, and our knowledge to push the fashion industry towards a more inclusive and sustainable future. &ZeroWidthSpace; &ZeroWidthSpace;
 
 
 
 
 
 
 Additional Information
 
 
 
 
 This is a full-time position, reporting to Legal Counsel in the Legal team for India.
 
 
 
 
 Apply by sending in your applications in English as soon as possible, but no later than December 24th, 2025. Due to data policies, we only accept applications through career page.
 
 
 
</div>

Compliance Specialist

DICETEK LLC

<div>ROLE PURPOSE:
Responsible for obtaining required documents from the customer for keeping up to date customer information in line with global and local regulations around FCC, KYC and customer due diligence. Perform periodic &amp; trigger event reviews and analysing KYC-ODD gaps. Ensure the accuracy of opened and modified accounts and making sure that they&rsquo;re complying with the policies and procedures set. 
 
Specialist Skills / Technical Knowledge Required for this role:
<ul><li>Good knowledge of A KYC, ODD procedures or business unit&rsquo;s functional area or products.
</li><li>Fair Knowledge of UAE banking practices , regulations &amp; risks
</li><li>Good Knowledge of Anti-Money laundering regulations issued by the UAE Central Bank and other regulatory authorities
</li><li>Knowledge of Anti-Money laundering regulations issued by the UAE Central Bank and other regulatory authorities
</li><li>Computer skills
</li><li>Excellent Communication Skills in English
</li><li>Arabic knowledge is not a must but preferable (Written/Read) 
</li></ul> 
Previous experience(If any):
<ul><li>Minimum of 1 year Banking experience is preferable
</li><li>Experience in Regulatory Compliance, FCC teams, Account Opening or KYC teams and/or experience in customer facing roles (ARM, RM) is preferable</li></ul></div>

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