senior regulatory affairs specialist

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

confidentiial

Position Title: Senior Executive &ndash; Regulatory Affairs Location: United Arab Emirates Industry: Perfume &amp; CosmeticsRole Summary:We are seeking a detail-oriented and experienced Senior Executive-Regulatory Affairs to ensure that all our perfume products comply with local and international regulations. The role involves managing regulatory submissions, monitoring legal changes, and liaising with government authorities and certification bodies to ensure seamless compliance and market access.Key Responsibilities:<ul><li>Ensure all perfume and cosmetic products meet UAE regulatory requirements (MOHAP, ESMA, Dubai Municipality, etc.) and international standards (GCC, EU, IFRA, etc.).</li><li>Manage product registration, label approvals, and documentation for existing and new products.</li><li>Maintain updated knowledge of regulatory changes and proactively assess their impact on the business.</li><li>Liaise with local authorities, labs, and certification bodies for product assessments, safety reports, and regulatory clearances.</li><li>Collaborate with R&amp;D, QA/QC, production, and marketing teams to ensure compliance from formulation to packaging.</li><li>Oversee the creation and maintenance of SDS (Safety Data Sheets), product dossiers, and technical files.</li><li>Manage audits and inspections by authorities and provide timely corrective actions if required.</li><li>Train internal teams on regulatory procedures and compliance updates.</li><li>Ensure that advertising and product claims meet the legal and regulatory standards.</li></ul>Requirements:<ul><li>Bachelor's or Master's degree in Chemistry, Pharmacy, Regulatory Affairs, or related field.</li><li>Minimum 5&ndash;7 years of experience in regulatory affairs in the perfume, cosmetics, or FMCG industry.</li><li>Strong understanding of UAE and GCC regulatory frameworks, especially Dubai Municipality (Montaji system), ESMA, and SFDA.</li><li>Familiarity with IFRA standards, REACH, and international labeling norms.</li><li>Excellent communication and coordination skills.</li><li>Proficient in technical writing and regulatory documentation.</li></ul>Job Types: Full-time, PermanentPay: AED6,500.00 - AED9,500.00 per monthWork Location: In person

Senior Executive- Regulatory Affairs

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>

Hologic

<div>Why Hologic:

Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence. 
What to expect:

Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications.

The position has primary responsibility for compliance with US, EU and Canadian regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide for medical devices and includes support of product changes to ensure that regulatory requirements continue to be met, documenting regulatory decisions, submissions to agencies, reviewing US promotional materials, and ensuring that documentation is current and accurate from a regulatory perspective. Responsibilities are performed through the collaboration with various functions across the business, including but not limited to Regulatory Affairs, Research and Development, Clinical, Quality, and Marketing.

Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.

A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is a fully qualified, career-oriented, journey-level position. Normally receives little instruction on day-to-day work, general instructions on new assignments.

Or:

Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Supports product release process.

The position has primary responsibility for compliance with international registrations to support worldwide product commercialization or continued market access for medical devices. Works to ensure that regulatory requirements continue to be met and ensuring that documentation is current and accurate from a regulatory perspective. Responsibilities are performed through collaboration with various functions across the business, including but not limited to Regulatory Affairs, Research and Development, Clinical, Quality, and Marketing.

Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.

A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is a fully qualified, career-oriented, journey-level position. Normally receives little instruction on day-to-day work, general instructions on new assignments.

What we expect:
<ul>
<li>Responsible for the preparation and compiling of document packages for regulatory submissions, audits and inspections. Participates in technical review of data or reports that will be incorporated.</li>
<li>Manage and maintain regulatory databases and technical files.</li>
<li>Participate in internal and external audits and investigations.</li>
<li>Reviews materials such as labeling, marketing materials or user manuals to ensure compliance with regulatory agency requirements and laws.</li>
<li>Manage labeling and unique device identification requirements. Recommends changes for labeling, manufacturing, marketing and clinical protocols for regulatory compliance.</li>
<li>Provides high-level regulatory support on projects and cross functional teams. Provides technical guidance on design reviews and regulatory strategies for product approval.</li>
<li>Contribute to developing or improving processes, procedures and standards that contribute to meeting internal SOP&rsquo;s, regulatory and industry regulations.</li>
<li>Maintains current knowledge of existing and emerging regulations, standards and laws.</li>
</ul>
Education
<ul>
<li>Preferred Minimum Non-Technical Degree: College Degree</li>
<li>Preferred Minimum Technical/Advanced Degree: Technical Bachelor&rsquo;s Degree</li>
</ul>
Experience
<ul><li>Preferred Minimum Non-Technical Degree: 5-8 Years</li>
<li>Preferred Minimum Technical/Advanced Degree: 2-5 Years with Technical Bachelor&rsquo;s Degree, 1-3 Years with Master&rsquo;s Degree, 0-1 Years with PhD
<ul><li>Experience with the creation of technical files and documentation</li>
<li>Experience working in regulated medical device industry.</li>
</ul></li></ul>Skills
<ul>
<li>Excellent communication, including verbal, technical writing, interpersonal and presentation skills.
<ul><li>Proficient with technology applications such as MS Office,</li>
<li>Knowledge of ISO 13485, ISO 9001, FDA, and foreign regulatory requirements</li>
</ul></li><li>Strong data and statistical analysis skills and ability to use data to make informed recommendations.
<ul><li>High degree of attention to detail</li>
</ul></li><li>Regulatory Affairs Certification (RAC) is beneficial.</li>
<li>Project Management Experience is beneficial.</li>
</ul>
The annualized base salary range for this role is $92,000 to $144,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand..

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

 Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

#LI-PR1 


Must follow all applicable FDA regulations and ISO requirements.

Hologic is an equal opportunity employer inclusive of female, minority, disabled and veterans, (F/M/D/V)</div>

Regulatory Affairs Specialist 3

PRANIC DRUG STORE LLC

Job Description: We are seeking a Regulatory Affairs Pharmacist to handle product registration and regulatory activities in the Sultanate of Oman. The ideal candidate will liaise with the Ministry of Health (MOH) and other relevant authorities to ensure our products meet all local regulatory requirements. This is an excellent opportunity for a motivated pharmacist to grow in regulatory affairs and make a meaningful impact in the pharmaceutical industry.Key Responsibilities:<ul><li>Prepare, compile, and submit product registration dossiers to the Omani Ministry of Health.</li><li>Ensure all product documentation, labeling, and packaging comply with local regulations.</li><li>Follow up with MOH on product registration approvals.</li><li>Maintain accurate regulatory records and track progress of submissions.</li><li>Provide guidance on regulatory compliance for internal teams.</li><li>Assist with any audits or inspections as required.</li></ul>Requirements:<ul><li>Bachelor&rsquo;s degree in Pharmacy (BPharm / PharmD).</li><li>0&ndash;5 years of experience in the pharmaceutical industry.</li><li>Valid Sultanate of Oman Pharmacist License is mandatory.</li><li>Knowledge of MOH regulations and product registration processes is a plus.</li><li>Strong organizational and communication skills.</li><li>Ability to work independently and manage multiple tasks.</li></ul>Why Join Us:<ul><li>Opportunity to grow and gain experience in regulatory affairs.</li><li>Work in a dynamic team environment.</li><li>Contribute to bringing quality healthcare products to Oman.</li></ul>How to Apply: Interested candidates should submit their CV and a copy of their valid Sultanate of Oman pharmacist license to pranicdrugstorellc@gmail.com or apply directly via Indeed.Job Type: Full-time

Regulatory Affairs Pharmacist – Oman Experience Mandatory

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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Regulatory Affairs Pharmacist – Oman Experience Mandatory

EM&S Turkey Regulatory Affairs Officer