regulatory affairs officer

STAR Human Resource Services (Private) Limited

Pharm.D / Bachelor&rsquo;s or Master&rsquo;s in Pharmacy, Chemistry, or related field.2&ndash;4 years of relevant experience in regulatory affairs. (cosmetics/pharma/personal care preferred)Prepare and process product registration files and renewals.Coordinate with teams for artwork and documentation as per guidelines.Communicate with regulatory authorities and manage queries.Maintain records, track regulatory changes, and ensure compliance.Job Type: Full-timePay: Rs80,000.00 - Rs110,000.00 per monthWork Location: In person

Senior Regulatory Affairs Officer

Besins Healthcare

Key Responsibilities:<ul><li>Acts as responsible Regulatory Team member for assigned regulatory projects.</li><li>Preparation and submit Life-Cycle Maintenance regulatory submissions for Africa (English and French Speaking).</li><li>Prepares and/or reviews regulatory documentation for National applications in line with assigned timelines.</li><li>May support on some R&amp;D regulatory projects.</li><li>Actively participates and employs effective communication practices with internal stakeholder (CMC, Supply Chain, Quality, Legal, Clinical, Medical, Pharmacovigilance, and Globally based Regional Regulatory affairs team</li><li>Understands the Scope of Work, timelines and deliverables for a given project.</li><li>Prepare status reports and metrics for assigned projects.</li><li>Perform assigned work according to current best good regulatory practice/guidelines in compliance with current legislation.</li><li>Any other duties as assigned by your manager.</li><li>Learn, develop, and train.</li></ul>_Technical Skills/ Experience_<ul><li>&gt;4-5 years pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Africa, Middle East, Asia (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions)-Europe/Turkey experience is and advantage.</li><li>Preparation of relevant CTD (Common Technical Dossier) documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling operations.</li><li>Experience of GCC markets/ICH guidelines/MHRA guidelines</li><li>Experience of emerging markets / international RoW markets and regulatory filings.</li><li>Quality control review of technical/ regulatory documents.</li><li>Understanding of Regulatory strategy and determination of documentation requirements. Compliance with SOPs, Change controls and regulatory best practices.</li><li>Publishing: eCTD and or NEES.</li><li>Pharmaceutical artwork review and sign-off.</li><li>Project management experience - an advantage.</li><li>Experience of Women s and/or Men s healthcare an advantage</li></ul>_Soft Skills_<ul><li>Ability to work to tight timelines and manage peaks in workload.</li><li>Good team player with internationally based colleagues in Global Pharmaceutical Affairs team.</li><li>Positive can-do attitude in growing company with expanding range of therapeutic product range.</li><li>Good negotiating skills and the ability to identify and resolve issues with external stakeholders.</li><li>Excellent verbal and written communication skills.</li><li>Excellent computer skills e.g. Word, Excel, data and document management systems.</li><li>Cultural awareness for global ways of working.</li><li>Able to act as a mentor to junior colleagues and to assist in their training and development as appropriate.</li><li>Desire to grow regulatory operational and regulatory strategy experience.</li><li>Languages: Speaking &amp; Writing French is a Must- Fluent Arabic/English Required as well.</li></ul>_Minimum required education and experience_<ul><li>Degree in Pharmacy or life science-related degree plus at least 4-5 year s relevant human pharmaceutical experience with focus on filing and lifecycle maintenance of marketed products in Middle East/ Africa/Asia</li></ul>

Regulatory Affairs Officer

Boutiqaat

<div>
 
 Do you speak fluent &ldquo;regulation&rdquo;?
 
 
 
 
 
 Are you the type of person who reads the fine print for fun and loves making sure every "I" is dotted, and "T" is crossed?
 
 
 If keeping a business complaint, audit-ready, and ahead of regulations sounds like your kind of challenge, we want you on our team.
 
 
 
 
 
 At Boutiqaat, we're growing fast but never at the expense of integrity. That&rsquo;s why we&rsquo;re looking for a detail-obsessed, policy-savvy Regulatory Affairs &amp; Compliance Specialist to ensure our operations meet local and global standards without missing a beat.
 
 
 
 
 
 
 What You&rsquo;ll Be Doing:
 
 
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 Monitor and interpret regulatory requirements, standards, and legislation relevant to our industry
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 Develop, implement, and maintain compliance policies, procedures, and controls
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 Prepare and submit regulatory filings, documentation, and reports to authorities
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 Act as the internal expert on compliance and regulatory risk
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 Liaise with regulatory agencies, legal advisors, and third-party auditors
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 Train and support teams on compliance procedures and updates
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 Assist in audits, inspections, and risk assessments
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 Identify and mitigate compliance gaps or risks before they become issues
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 Ensure we&rsquo;re not just compliant but confident
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 </ul>
 
 
 
 
 
 What You Bring to the Table:
 
 
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 Bachelor&rsquo;s degree in Regulatory Affairs, Law, Life Sciences, or related field
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 3+ years&rsquo; experience in regulatory compliance or affairs.
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 Deep knowledge of local and international regulations and industry standards
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 Meticulous attention to detail and documentation skills
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 Strong communication, both written and verbal
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 Integrity-driven, analytical thinker with a proactive mindset
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 Comfortable working independently and cross-functionally
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 </ul>
 
 
 
 
 Why Boutiqaat?
 
 
 
 
 
 
 At Boutiqaat, you won&rsquo;t just join a company you&rsquo;ll join a movement redefining e-commerce beauty and lifestyle retail. Here, every day offers new challenges, learning opportunities, and a chance to help build a smarter, more efficient operation from the ground up.
 
 
 
 
 
 
 Ready to Grow with Us?
 
 
 
 Kickstart your career with hands-on experience, expert mentorship, and real impact.
 
 
 
 
 
 Apply now and be part of something exciting!
 
 
 
</div>

Regulatory Affairs & Compliance Officer- Product Registration

Rawaj - Human Capital Management

<div>Leverage your abilities and join a leading medical device manufacturer driving compliance and innovation across Saudi Arabia.
The Regulatory Affairs Manager ensures all medical devices comply with SFDA and international standards by managing product registrations, renewals, and documentation.<h3 class="jobSectionHeader">
Key Accountabilities</h3><ul><li>
Prepare, review, and submit regulatory files, technical documentation, and ESTD to SFDA.</li><li>
Manage communication with SFDA authorities for product approvals and renewals.</li><li>
Track and interpret new regulations impacting medical device compliance.</li><li>
Maintain product registration database and ensure documentation accuracy.</li><li>
Collaborate with QA, R&amp;D, and Production to ensure regulatory alignment.</li></ul><h3 class="jobSectionHeader">
Knowledge, Skills, and Experience</h3><ul><li>
Bachelor&rsquo;s degree in Pharmacy, Biomedical Engineering, or Science.</li><li>
8+ years of experience in Regulatory Affairs for medical devices.</li><li>
Solid knowledge of SFDA requirements, ISO 13485, and MDSAP.</li><li>
Strong documentation and submission management skills.</li><li>
Excellent English communication.</li></ul></div>

Regulatory Affairs Manager| Officer – Medical Devices | Saudi Arabia

Cigalah Gulf Medical

Job Opening: Regulatory Affairs Officer / CoordinatorLocation: Kingdom of BahrainWe are looking for a Regulatory Affairs Officer / Coordinator to join our growing pharmaceutical team. The ideal candidate will play a key role in ensuring our company&rsquo;s full compliance with NHRA regulatory requirements, supporting product registrations, renewals, and quality-related operations.Qualifications &amp; Requirements:<ul><li>Bachelor&rsquo;s Degree in Pharmacy (BS Pharmacy)</li><li>Must possess a valid NHRA license (Bahrain)</li><li>4&ndash;5 years of proven experience in Regulatory Affairs within the pharmaceutical industry</li><li>Solid understanding of NHRA and GCC regulatory guidelines and procedures</li><li>Experience in Quality Assurance (QA), Quality Systems, and Regulatory Compliance</li><li>Excellent knowledge of dossier preparation, submission, and tracking</li><li>Strong organizational and documentation skills with keen attention to detail</li><li>Good communication and interpersonal skills</li><li>Must be currently residing in Bahrain</li><li>Able to join immediately</li></ul>Key Responsibilities:<ul><li>Prepare, compile, and review regulatory dossiers for product registration, renewals, and variations in compliance with NHRA/GCC requirements</li><li>Liaise effectively with NHRA officials and other health authorities to ensure timely approvals</li><li>Maintain and update product licenses, certificates, and technical documentation</li><li>Ensure regulatory compliance for all marketed pharmaceutical products</li><li>Support internal and external audits, quality reviews, and inspection readiness activities</li><li>Collaborate with cross-functional departments (QA, Supply Chain, Production, etc.) to ensure adherence to company and regulatory standards</li><li>Stay up to date with changing regulations, guidelines, and industry trends affecting product registration and compliance</li></ul>Job Type: Full-time

Regulatory Coordinator

Allmed Solutions

Job descriptionWe are seeking a highly motivated and detail-oriented professional to join our Regulatory Affairs team. The Senior Officer &ndash; Regulatory Affairs will be responsible for overseeing all regulatory activities related to medical devices, ensuring full compliance with local and international regulatory standards.Key Responsibilities:<ul><li>Develop and implement effective regulatory strategies for product approvals.</li><li>Manage product registration and documentation processes.</li><li>Ensure compliance with regulatory requirements .</li><li>Coordinate and communicate with regulatory agencies for submissions and approvals.</li><li>Maintain ongoing regulatory compliance throughout the product lifecycle.</li><li>Support cross-functional teams with regulatory insights and updates.</li></ul>Requirements:<ul><li>Master&rsquo;s degree (MSc.) in a relevant field.</li><li>1&ndash;2 years of experience in regulatory affairs, preferably in medical devices.</li><li>Excellent communication, documentation, and analytical skills.</li><li>Proven ability to multitask, prioritize, and meet strict deadlines in a fast-paced environment.</li></ul>Job Type: Full-timePay: Rs50,000.00 - Rs120,000.00 per monthWork Location: In person

Senior Officer – Regulatory Affairs

UTOPIA INDUSTRIES PVT LTD

Regulatory Compliance Officer/ Specialist &ndash; Dietary SupplementsEducation: Bachelor&rsquo;s/Master&rsquo;s degree in Pharmacy, Food Science, Nutrition, Biotechnology, or Regulatory Affairs.Experience: Minimum 3&ndash;5 years in product regulatory compliance, preferably in dietary supplements, cosmetics, or nutraceuticals.KeyResponsibilities:<ul><li>Ensure all dietary supplements comply with U.S. FDA Dietary Supplement regulations under the FD&amp;C Act and 21 CFR 111 (cGMP).</li><li>Review and verify supplier documentation, including Certificates of Analysis (COA), GMP certificates, NDI notifications, product dossiers, permitted ingredients, prohibited or restricted ingredients and formulation specifications.</li><li>Ensure scientific substantiation of ingredient functions and claims.</li><li>Review all product labels, claims and Amazon listings for compliance with FDA labeling guidelines (identity statement, net quantity, Supplement Facts, ingredient declaration, warnings).</li><li>Communicate with suppliers to ensure documentation completeness, GMP certification, facility registration, and FDA establishment listing and product conformity.</li><li>Evaluate supplier test data for microbial, heavy metals, and purity compliance.</li><li>Ensure all required premarket notifications (e.g., NDIN, if applicable) are filed or confirmed by the supplier, manage product listing on Amazon and FDA notification (via SPL) if needed.</li><li>Oversee post-market vigilance, including consumer complaint tracking, recall coordination, and adverse event reporting.</li><li>Work closely with QA/QC, Procurement, and Marketing teams to integrate regulatory compliance early in product selection.</li><li>Support packaging and labeling approval cycles before production.</li></ul>Job Type: Full-timeWork Location: In person

Regulatory Affairs Specialist

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