regulatory affairs officer

Sanofi

<div>EM&amp;S Turkey Regulatory Affairs Officer<ul><li>
Location: Istanbul</li></ul>
About the job
Reporting to the EM&amp;S Middle East Quality Manager, the Regulatory Affairs Officer supports regulatory compliance and lifecycle activities related to External Manufacturing &amp; Supply operations. The role ensures alignment between regulatory dossiers and industrial practices at CMO, in compliance with local regulations and Sanofi standards, and acts as a key interface between Affiliate Regulatory Affairs and CMO.
This position contributes to the implementation of Sanofi&rsquo;s Quality and Regulatory policies within External Manufacturing &amp; Supply activities, ensuring regulatory compliance of manufactured products, supporting product lifecycle management, and enabling timely execution of regulatory-impacting changes and transfers.
Main responsibilities:<ul><li>
Regulatory Compliance &amp; Lifecycle Management<ul><li>
Ensure regulatory compliance between CMC dossiers / Marketing Authorizations and manufacturing practices at CMOs</li><li>
Coordinate the regulatory compliance exercise with the assigned Hub</li><li>
Maintain regulatory compliance of manufactured products throughout their lifecycle (variations, renewals, annual updates)</li><li>
Support the preparation, maintenance, and update of CMC dossiers for assigned products</li><li>
Assess the regulatory impact of proposed changes (change controls) originating from CMO or internal sites</li><li>
Support Product Registration Renewals and periodic regulatory submissions (Annual Reports, PQRs&hellip;)</li><li>
Contribute to the implementation of Sanofi Quality policy across External Manufacturing activities</li></ul></li><li>
Regulatory Interface &amp; Submissions Support<ul><li>
Act as the regulatory interface between Affiliate Regulatory Affairs, site Regulatory teams, CMOs, and the Hub</li><li>
Consolidate industrial and technical data required for local and regional registrations and variations</li><li>
Support responses to Health Authority requests (RFI, deficiency letters)</li><li>
Monitor submission and approval status and ensure appropriate communication of regulatory approvals and implementation timelines</li><li>
Perform regulatory review and approve documentation provided by the Hub prior to submission while ensuring documentation management within Sanofi systems (Veeva Vault)</li><li>
Manage regulatory activities in Veeva Vault (Regulatory Objective, SCP&hellip;)</li><li>
Participate in Quality System activities, including Change Control, CAPA, PQR, training, and documentation management</li><li>
Support regulatory aspects of technology transfers, product transfers, and site projects in collaboration with Quality, Supply Chain, and Project teams</li><li>
Prepare the Variation Record Card (VRC) for product divestments</li></ul></li><li>
Site Compliance &amp; Regulatory Maintenance<ul><li>
Compile and maintain product specification files and support updates of the Site Master File (SMF)</li><li>
Support the maintenance of manufacturing licenses, GMP certificates, site registrations, and renewals</li><li>
Participate in internal audits, external audits, and regulatory inspections, supporting preparation and follow-up activities</li><li>
Contribute to continuous improvement initiatives related to Regulatory Affairs processes and procedures</li></ul></li><li>
HSE &amp; Compliance Awareness<ul><li>
Ensure compliance with applicable HSE rules and procedures</li><li>
Report accidents and incidents occurring in the workplace in line with internal requirements</li><li>
Support site and Quality initiatives promoting compliance and quality culture (Quality Day)</li></ul></li><li>
Compliance &amp; Ethics<ul><li>
Comply with the Company's Code of Ethics, upholding high professional standards of conduct</li><li>
Demonstrate a commitment to protecting and enhancing the Company's reputation</li><li>
Maintain comprehensive knowledge of regulatory guidance, technical developments, ethics, and governance requirements relevant to the role</li><li>
Apply ethical principles and governance standards to all work activities</li></ul></li></ul>
About you
<ul><li>Education: Bachelor&rsquo;s degree or higher in Pharmacy, Chemistry, Microbiology, Quality, or a related scientific field</li><li>
Experience: At least 5 years&rsquo; experience in the pharmaceutical industry, preferably with 2 years+ in a similar role, working in a regulatory team.<ul><li>
Proven ability to manage multiple priorities effectively</li><li>
Experience in management of change control with regulatory impact</li></ul></li><li>
Skills:
<ul><li>Good knowledge of pharmaceutical regulatory requirements (EU and local regulations)</li><li>
Understanding of CMC dossiers, variations, and product lifecycle management</li><li>
Familiarity with External Manufacturing / CMO environments is a plus</li><li>
Working knowledge of Quality Systems (Change Control, CAPA)</li><li>
Ability to compile, review, and manage technical and regulatory documentation</li><li>
Comfortable using digital tools (Excel, PowerPoint, and regulatory document management systems)</li></ul></li><li>
Languages: Fluency in English is required, knowledge of other languages is an asset</li></ul>
Why choose us?<ul><li>
Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.</li><li>
Be part of an organization that invests in people, technology, and sustainability, leading the industry in low-carbon manufacturing and digital transformation.</li></ul>
#LI-EUR
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EM&S Turkey Regulatory Affairs Officer

Tibbi Pvt LTD

Position Title: Compliance Officer Company: Aesthetics Lab by Tibbi Location: Garden townJob Overview:Aesthetics Lab by Tibbi is seeking a detail-oriented and ethical Compliance Officer to ensure that our operations, procedures, and services meet legal and regulatory standards. The ideal candidate will help maintain internal controls, support audits, and promote a culture of compliance across all departments particularly within the aesthetics and wellness sectors.Key Responsibilities:<ul><li>Monitor and enforce compliance with regulatory and legal requirements relevant to the aesthetics industry.</li><li>Develop, review, and update internal policies and procedures to ensure alignment with national and local laws.</li><li>Conduct regular audits and risk assessments across operations.</li><li>Stay up-to-date with industry regulations, especially those relating to health, safety, and data privacy.</li><li>Train staff on compliance procedures, code of conduct, and best practices.</li><li>Investigate and document compliance breaches, and recommend corrective actions.</li><li>Act as the point of contact for regulatory agencies and support during inspections or investigations.</li><li>Maintain accurate records of compliance activities, including complaints and audit results.</li><li>Collaborate with management to resolve compliance issues proactively.</li></ul>Qualifications:<ul><li>Bachelor&rsquo;s degree in Law, Business Administration, Healthcare Management, or a related field.</li><li>Proven experience (2+ years) in compliance, auditing, or regulatory affairs&mdash;preferably within healthcare or aesthetics.</li><li>Strong knowledge of relevant laws, standards, and ethical practices</li><li>Familiarity with health and safety standards, data protection regulations and clinical practice guidelines.</li></ul>Preferred Skills:<ul><li>Excellent attention to detail and analytical thinking.</li><li>Strong communication and interpersonal skills.</li><li>Ability to manage sensitive situations with confidentiality and professionalism.</li><li>Proficient in compliance management software and Microsoft Office tools.</li><li>Ability to train, mentor, and influence others regarding compliance standards.</li></ul>Job Type: Full-timeApplication Question(s):<ul><li>How much experience do you have in Aesthetics ?</li><li>what is your salary expectations ?</li><li>what is you current/last salary ?</li></ul>Education:<ul><li>Bachelor's (Preferred)</li></ul>Work Location: In person

Compliance Officer

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

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

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>

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>

Minapharm Pharmaceuticals

<div>
 
 
 
 
 About Minapharm:
 
 
 
 
 
 Minapharm Pharmaceuticals is a leading pharmaceutical company in Egypt and the Middle East and the largest end-to-end manufacturer of biological therapies in MEA with over 20 years of experience in cellular and bioprocess engineering.
 
 
 
 
 
 Headquartered in Cairo, Minapharm commercializes over 100 life-saving and life-enhancing products ranging from small molecules to complex bioengineered proteins and viral vectors, with an impressive immunotherapy pipeline.
 
 
 
 
 
 Together with its wholly-owned Berlin-based subsidiary, ProBioGen AG - a world-leading CDMO; Minapharm has established an integrated business model making it the only gene-to-market company in the region.
 
 
 
 
 
 Consolidating its international platform of intelligent biopharmaceutical technologies with the longstanding process development and manufacturing expertise in the MEA, Minapharm, together with ProBioGen, have incorporated MiGenTra GmbH headquartered in Berlin and manufacturing in Cairo, to enhance the accessibility to critical healthcare transforming medicines through product development and commercialization of Biosimilar mABs, Cell, and Gene Therapies and vaccines, at affordable prices in Egypt, and MEA.
 
 
 
 
 
 Minapharm Group of Pharmaceutical Companies employ a collective workforce of more than 1400 individuals &amp; continue to expand their workforce with Talented Human Capital
 
 
 
 
 
 
 
 
 Our Core Values:
 
 
 
 
 
 &middot; Diversity &amp; Respect
 
 
 &middot; Integrity &amp; Accountability
 
 
 &middot; Collaboration
 
 
 &middot; Leadership &amp; Empowerment
 
 
 &middot; Innovation &amp; Continuous Learning
 
 
 
 
 
 
 Job Mission :
 
 
 
 Successful job Holder will handle all related new registration/re-registration/variation files of Minapharm/MiGenTra products, ensuring compliance with Egyptian Drug Authority (EDA) guidelines to secure marketing authorizations. Key missions include preparing and submitting registration dossiers &amp; handling renewals and variations.
 
 
 
 
 
 
 Duties &amp; Responsibilities
 
 :
 
 
 Regulatory Affairs - Manufacturing Sector
 
 
 &bull; Plan EDA Visits and communicate with EDA inspector(S).
 
 
 &bull; Ensure compliance with regulations set by EDA.
 
 
 &bull; Prepare and submit all documents and reports requested by the EDA.
 
 
 &bull; Prepare requirement to be ready on time; from QC Department in the Preparation of COAs and reference standards needed to be submitted with finished products samples to center lab NODCAR(&amp;or) Bio - inn
 
 
 &bull; Follow with validation department the submitting of the first three batches for any newly registered product.
 
 
 &bull; Follow Raw Materials upcoming RMs and their documents to facilitate EDA release process.
 
 
 &bull; Archive all the registration documents, EDA reports, samples &amp; COAs for products submitted to NODCAR (&amp;/OR) Bio-Inn.
 
 
 &bull; Follow all NODCAR (&amp;/OR) Bio-Inn requirements for samples submitted to Central lab (EDA)
 
 
 &bull; Handle EDA audits.
 
 
 &bull; Prepare a complete file for each product to contain all documents sent by Registration department
 
 
 &bull; Perform any additional tasks as requested and review Master Files, Drawings, Files related to EDA requirements.
 
 
 
 
 
 
 Qualifications (Educational Background &amp; Preferred work Experience)
 
 :
 
 
 -Not less than 6-9 years in relevant experience.
 
 
 -Education Background : Bachelor&rsquo;s degree in Pharmaceutical sciences is a must.
 
 
 -Training: Training workshops held by EDA or external parties dealing with new/existing law or guidelines related to registration in Egypt.
 
 
 
 
 
 -
 
 Functional / Technical Competencies
 
 : Strong Expertise in the following:
 
 
 &bull;Guidelines of registration process.
 
 
 &bull;Inspection/licensing procedures/ different registration ministerial decree/procedures of different registration submission (stability/pharmacology/naming/variation)
 
 
 
 
 
 -
 
 Behavioral Competencies
 
 :
 
 
 &bull; Business Acumen
 
 
 &bull;Good Communication Skills
 
 
 &bull; Previous proven previous close interaction with Egyptian Drug Authority (EDA)
 
 
 
 
 
 
 Additional Skills:
 
 
 
 &bull; Computer Skills Literacy (familiar with word/excel/PP).
 
</div>

Regulatory Affairs Expert

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