regulatory specialist

Proservartner

Regulatory Specialist &ndash; Food &amp; Beverage (SFDA-aware)About Proservartner Proservartner is a leading management consulting firm specialising in strategic advisory, market assessments, and transformation projects across FMCG, beverage, manufacturing, and financial sectors. We partner with clients to deliver actionable insights, investment-grade analyses, and implementation-ready strategies. We are currently staffing a 14&ndash;16 week consulting engagement in Saudi Arabia focused on the water-products market and are seeking experienced professionals with FMCG, beverage, and financial modelling expertise.Duration: 6&ndash;8 weeks Rate: USD 560&ndash;720/dayRole Overview: The Regulatory Specialist will ensure compliance with Saudi Food &amp; Drug Authority (SFDA) regulations, including product classification, labelling, and claims.Key Responsibilities:<ul><li>Classify products and ensure regulatory compliance.</li><li>Advise on labelling, claims limits, and risk mitigation.</li><li>Support project team with regulatory insights and approvals.</li><li>Maintain up-to-date knowledge of KSA F&amp;B regulations.</li></ul>Requirements:<ul><li>SFDA or KSA food &amp; beverage regulatory experience.</li><li>Knowledge of labelling, claims limits, and compliance risks.</li><li>Strong analytical and documentation skills.</li></ul>Job Type: Full-timePay: From ﷼2,100.00 per day

Regulatory Specialist - Food & Beverage (SFDA-aware)

<div>Site Name: Poznan Grunwaldzka, Bengaluru Luxor North Tower, Egypt - Cairo, Warsaw Rzymowskiego 53 
Posted Date: Mar 3 2026 
Senior Regulatory Specialist, CMC Renewals
Renewals CMC Team (Chemistry, Manufacturing, and Controls) plays a crucial role in ensuring that Pharma and Vaccines products are safe, effective, and of high quality for patient use. Team is responsible for authoring, compiling, and checking regulatory submissions related to drug manufacturing and quality control. While the science is our main area we are also working with technology to perform at our best as we operate in a fast-paced and evolving environment.
Key Responsibilities:<ul><li>
Independently manages multiple CMC (Chemistry, Manufacturing and Control) renewals assignments for Pharma and Vaccines products including response to questions from Agency; assignments will range in complexity but more complex work is expected;</li><li>
Independently and confidently defines and agrees on regulatory strategy, completes data assessment to ensure CMC dossier is authored in compliance with Company regulatory processes and external requirements for international markets;</li><li>
Identifies risks associated with submission data and information packages;</li><li>
Escalates issues with line manager that have business impact, suggesting possible solutions;</li><li>
Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications;</li><li>
Identifies improvement opportunities for regulatory processes, policies and systems;</li><li>
Serves as dossier reviewer (peer review and/or quality check);</li><li>
Provides consultation and solutions being the subject matter expert in specific areas of expertise. Acts as mentor/trainer for new staff;</li><li>
Effectively communicates also in a digital context, including virtual meetings and digital platforms;</li><li>
Works with colleagues in Global Manufacturing &amp; Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time;</li><li>
Understands internal/external regulatory environment;</li><li>
Monitors regulatory intelligence and acts proactively on identified changes to regulatory requirements;</li><li>
Supports digital transformation through active participation in building digital skills.</li></ul>
Why You?
Basic qualifications:<ul><li>
Min. bachelor's degree in Life Sciences, Chemistry, Health Sciences, or related fields;</li><li>
Min. 3 years of relevant experience in regulatory affairs, pharmaceutical industry (familiarity with post-approval CMC regulatory procedures and ICH CTD documentation is required);</li><li>
Understanding of the pharmaceutical industry, drug development environment, and regulatory processes;</li><li>
Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner;</li><li>
Mindset that embraces digital transformation and innovation through adaptability, forward-thinking, and exploring new possibilities in the ever-evolving digital landscape;</li><li>
Good team worker, ready to lead initiatives when needed (project management skills would be an asset);</li><li>
Excellent interpersonal skills; communication and influencing skills with the ability to work in a diverse environment and build relationships across a large organization;</li><li>
Excellent time management skills to handle multiple assignments, prioritize and schedule work to meet business needs;</li><li>
Detail-oriented, with emphasis on accuracy, completeness and consistency;</li><li>
Agile and analytical thinking to independently provide solutions to issues or propose process/ways of working changes;</li><li>
Adaptability and Learning: A commitment to ongoing professional development with proven ability to learn and apply new concepts;</li><li>
Veeva Vault knowledge would be an asset.</li></ul>
What we offer
You will join a supportive and inclusive team where your voice matters. You will get development opportunities that match your ambitions. You will do work that contributes to meaningful outcomes for patients and communities.
#LI-GSK
#LI-HYBRID
The annual base salary in Poland for new hires in this position ranges from PLN 144,750 to PLN 241,250 gross, taking into account a number of factors including the candidate&rsquo;s skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non-discretionary criteria) and/or awards for exceptional performance (granted at the employer&rsquo;s discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave &amp; care of family member leave. 
More detailed information on the total reward package applicable to your role will be supplied during the recruitment process. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the market rate for the role.
As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases &ndash; to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we&rsquo;re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK&rsquo;s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/</div>

Senior Regulatory Specialist, CMC Renewals

SEGULA Technologies

<div>Company Description 
Do you want to shape the world of tomorrow and work on innovative projects? Then you're a good fit for us! We are a global engineering group with 15,000 employees and 140 locations worldwide. With our services, we are driving the topics of energy efficiency, climate protection and decarbonization and developing tech industries into new dimensions.
The world of SEGULA Technologies Experts revolves around industries such as automotive, software, energy and life sciences. As an independent player, we support OEMs and suppliers with personal engineering services. Take advantage of new opportunities and take on exciting tasks and attractive positions with direct customer assignment. 
Job Description 
Job Title: Local PRO (Permitting &amp; Regulatory Specialist &ndash; Construction) 
Location: Saudi Arabia (KSA) 
Industry: Automotive / Industrial Construction Projects 
Experience: 10&ndash;12+ years (KSA civil/industrial projects mandatory) 
Languages: English (required). Arabic (strong advantage)
Job Summary
We are looking for an experienced Local PRO / Permitting &amp; Regulatory Specialist to support an automotive industrial construction program in Saudi Arabia. You will advise the project owner on local regulations, permitting, utilities connections, importation processes, schedule baselines, and cost assumptions, while identifying project risks and mitigation actions.
Key Responsibilities
Local regulatory &amp; administrative processes<ul><li>
Lead and advise on KSA construction administrative processes and local regulations (building permits, environmental permits, site servicing approvals).</li><li>
Provide and manage a clear list of required procedures and step-by-step process including timelines, documentation, submissions, and approvals.</li><li>
Support interfaces with local authorities and stakeholders for permits, certifications, and compliance.</li></ul>
Permitting &amp; environmental approvals<ul><li>
Building permit process: dossier content, submission process, typical review duration, and conformity certification.</li><li>
Environmental approvals: impact studies and operational agreements (classified installations, hazardous studies), including process, timelines, and certification.</li><li>
Site servicing approvals: water, gas, electricity, wastewater/rainwater discharge authorizations.</li><li>
Owner responsibility controls and measurements (water/air discharges, waste, electrical/pressurized/lifting equipment compliance).</li></ul>
Construction execution support<ul><li>
Advise on KSA local standards for workplace design and typical construction practices (project organization, Design &amp; Build, GC management).</li><li>
Assess major risks for industrial construction in KSA (location, climate, organization, technical, schedule, cost, quality, HSE) and propose mitigation plans.</li><li>
Provide guidance on free zone-specific construction processes (if applicable).</li></ul>
Cost intelligence &amp; market inputs<ul><li>
Provide construction cost benchmarks and ratios for buildings, roads, and utilities items (engineering + construction).</li><li>
Estimate labor cost benchmarks for key roles (PM, design engineers, draftsman/technicians, site manager, works leader, skilled workers, workers).</li><li>
Monitor construction inflation and provide forward-looking cost assumptions.</li><li>
Advise on material availability (imported vs locally available) and cost impact.</li><li>
Identify potential savings on local taxation (subsidies, exemptions, reductions) where applicable.</li></ul>
Importation of equipment<ul><li>
Define procedures and cost impacts for importation of new or modified (&ldquo;carry-over&rdquo;) equipment from Europe and other regions (e.g., China, Brazil).</li></ul>
Planning &amp; schedule management<ul><li>
Build/validate detailed schedules for design, procurement, documentation, preliminary works, site installation (life base, temporary utilities).</li><li>
Provide macro/micro schedules by lot for platform, buildings, facilities, and infrastructure (roads, parking, utilities).</li><li>
Provide local standard work calendar (week/year), including typical holiday periods and special events (e.g., Ramadan).</li></ul> 
Qualifications 
Qualifications &amp; Requirements<ul><li>
10+ years&rsquo; experience (12+ preferred) supporting civil/industrial construction projects in Saudi Arabia.</li><li>
Strong knowledge of KSA permitting, utilities connections, and authority processes.</li><li>
Proven ability to build accurate schedule baselines and cost benchmarks for industrial construction.</li><li>
Strong stakeholder management and communication skills (client-facing).</li></ul> 
Additional Information 
Preferred<ul><li>
Prior experience on large industrial/automotive plants, logistics hubs, or infrastructure-heavy projects in KSA.</li><li>
Arabic language skills.</li></ul>
Please note that only shortlisted candidates will be contacted</div>

Local PRO (Local Permitting & Regulatory Specialist) — KSA

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>

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

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>

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