regulatory affairs analyst

BioMarin Pharmaceutical

<div>Who We Are
 
 
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. 
 
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. 
 
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best &ndash; people with the right technical expertise and a relentless drive to solve real problems &ndash; and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we&rsquo;ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
 
 
About Worldwide Research and Development
 
 
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
Regulatory Affairs Associate - Turkey<ul><li>
Fixed Term Temporary position for up to 7 months (Maternity Leave Cover)</li><li>
Bachelors degree in Pharmacy, Chemical Engineering, Chemistry.</li><li>
Minimum 1 years of Regulatory Affairs experience in a pharmaceutical company,</li><li>
Excellent command of English (both written and spoken),</li><li>
Strong commitment to compatibility, scientific quality and integrity</li><li>
Analytical thinking</li><li>
Good communication and teamwork collaboration</li><li>
Good detail-capturing skills while working in a fast-moving environment</li><li>
Role is based in Turkey</li></ul><div>
JOB DESCRIPTION</div><ul><li>
Submission of Health Authority applications for registered and non-registered products and follow approval process. (GMP applications, new Marketing Authorization (MA) application, renewal submissions, lifecycle activities etc.)
</li><li>Compile all required documents received from Global Headquarters and prepare submission dossiers according to local requirements and make timely applications.
</li><li>Conduct the correspondences for all registered/non-registered products and follow up the Health Authority processes.</li><li>
Assist in managing global/local projects.</li><li>
Ensure the databases are updated on a timely basis.</li><li>
Evaluate local regulations/guidance for impact to any complex submission (e.g., MA, GMP) while ensuring that elements, quality, accuracy and format of regulatory submissions comply with applicable laws and regulatory standards.</li></ul>
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled 
 
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.</div>

Regulatory Affairs Associate - (Fixed Term Maternity Cover)

GlaxoSmithKline

Overview Position Summary: We are inviting UAE Nationals to join our Regulatory Affairs team in the United Arab Emirates as a Regulatory Affairs Associate. This role is crucial in ensuring compliance with local regulations while supporting product lifecycle management and regulatory submissions. You'll collaborate with cross-functional teams to align regulatory strategies with business goals and contribute to meaningful work that improves lives. Key Responsibilities <ul><li>Preparing, coordinating, and submitting regulatory documents in compliance with local regulations and GSK standards.</li><li>Ensuring timely submissions and approvals to support product launches and lifecycle maintenance.</li><li>Collaborating with internal teams and external stakeholders to align regulatory strategies with business objectives.</li><li>Maintaining regulatory databases and ensuring accurate record-keeping in line with compliance requirements.</li><li>Monitoring changes in local regulations and ensuring adherence to applicable laws and guidelines.</li><li>Providing regulatory guidance to cross-functional teams to support business operations.</li></ul> Basic Qualifications <ul><li>UAE National.</li><li>Bachelor's degree in pharmacy, Medicine, or a related field.</li><li>Proficiency in Microsoft Office tools (Word, Excel, PowerPoint).</li><li>Strong attention to detail and organizational skills.</li><li>Effective communication skills, both written and verbal.</li><li>Ability to work collaboratively in a team environment.</li></ul> Preferred Qualifications <ul><li>Previous experience in regulatory affairs or a related field.</li><li>Familiarity with regulatory submission processes and local guidelines.</li><li>Strong problem-solving skills and the ability to prioritize tasks effectively.</li><li>Interest in the pharmaceutical industry and regulatory compliance.</li><li>Ability to adapt to a fast-paced and dynamic work environment.</li><li>Commitment to continuous learning and professional development.</li></ul> Additional Information This role is based on-site in the United Arab Emirates. GSK is an equal opportunity employer and values diversity, equity, and inclusion. We welcome applications from UAE Nationals who are passionate about improving lives and ensuring compliance with local regulations. Application Process If you're ready to grow your skills, make a positive impact, and contribute to GSK's mission, apply today! 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 - to impact health at scale.People and patients around the world count on the medicines and vaccines we make, so we'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. Contact information You may apply for this position online by selecting the Apply now button. 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.<img src="https://www.jobg8.com/Tracking.aspx?GNl9oJpztr%2bFZiP5ZjITpj8ABsc%2f7ueRk" width="0" height="0" />

Regulatory Affairs Associate

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

<div>Site Name: UAE - Dubai 
Posted Date: Oct 23 2025 
Position Summary: 
We are inviting UAE Nationals to join our Regulatory Affairs team in the United Arab Emirates as a Regulatory Affairs Associate. This role is crucial in ensuring compliance with local regulations while supporting product lifecycle management and regulatory submissions. You&rsquo;ll collaborate with cross-functional teams to align regulatory strategies with business goals and contribute to meaningful work that improves lives.
Key Responsibilities: 
In this role, you will have the opportunity to develop your career while leading key activities such as:<ul><li>
Preparing, coordinating, and submitting regulatory documents in compliance with local regulations and GSK standards.</li><li>
Ensuring timely submissions and approvals to support product launches and lifecycle maintenance.</li><li>
Collaborating with internal teams and external stakeholders to align regulatory strategies with business objectives.</li><li>
Maintaining regulatory databases and ensuring accurate record-keeping in line with compliance requirements.</li><li>
Monitoring changes in local regulations and ensuring adherence to applicable laws and guidelines.</li><li>
Providing regulatory guidance to cross-functional teams to support business operations.</li></ul>
Basic Qualifications: 
To be successful in this role, you should have the following qualifications:<ul><li>
UAE National.</li><li>
Bachelor&rsquo;s degree in pharmacy, Medicine, or a related field.</li><li>
Proficiency in Microsoft Office tools (Word, Excel, PowerPoint).</li><li>
Strong attention to detail and organizational skills.</li><li>
Effective communication skills, both written and verbal.</li><li>
Ability to work collaboratively in a team environment.</li></ul>
Preferred Qualifications: 
We value candidates who bring additional skills and characteristics, such as:<ul><li>
Previous experience in regulatory affairs or a related field.</li><li>
Familiarity with regulatory submission processes and local guidelines.</li><li>
Strong problem-solving skills and the ability to prioritize tasks effectively.</li><li>
Interest in the pharmaceutical industry and regulatory compliance.</li><li>
Ability to adapt to a fast-paced and dynamic work environment.</li><li>
Commitment to continuous learning and professional development.</li></ul>
Additional Information: 
This role is based on-site in the United Arab Emirates. GSK is an equal opportunity employer and values diversity, equity, and inclusion. We welcome applications from UAE Nationals who are passionate about improving lives and ensuring compliance with local regulations.
Application Process: 
If you&rsquo;re ready to grow your skills, make a positive impact, and contribute to GSK&rsquo;s mission, apply today!
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.
Contact information:
You may apply for this position online by selecting the Apply now button.
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.</div>

SEPHORA

Get AI-powered advice on this job and more exclusive features. Reporting to: Compliance & Master Data Director At Sephora, beauty is about feeling seen, valued, and empowered, individually and collectively. It is connecting deeply with others, celebrating diversity and inclusivity, unlocking your potential and making a difference every day. Together, we belong to something beautiful. Since its inception in 1969 in Limoges, France, and as part of the LVMH Group since 1997, Sephora has been disrupting the prestige beauty retail industry. Today, Sephora continues to break with convention to drive its mission: champion a world of inspiration and inclusion where everyone can celebrate their beauty. With 56,000 employees in 35 countries, we connect customers and beauty brands within the world's most passionate beauty community. With a curation of nearly 500 brands, and our own label, Sephora Collection, we offer the most unique and diverse range of products: fragrances, makeup, hair care, skincare and much more. You will excel and enjoy this position if you are ready to actively handle the following missions: <ul> <li>To enter data from various source documents into the computer system for processing, here on the Authorities online system related to suppliers and products.</li> <li>Notification of Sephora Own Brand and Exclusive brands- prepares source data for computer entry by compiling and sorting information from regulatory documents such as ingredients lists / excel sheets prepared by the brands.</li> <li>Establishing entry priorities from brands and suppliers.</li> <li>Enters data in the online systems by inputting alphabetic and numeric information on keyboard according to screen format of the online system.</li> <li>Maintains data entry requirements/complies with data integrity.</li> <li>Check completed work for accuracy.</li> <li>Lead times for product notifications.</li> <li>Store completed documents in designed locations.</li> <li>Maintain the registration tracking files with certificates numbers and validity dates.</li> <li>Help and Support on the labelling Back and Forth exchanges with the brands and creation of artworks.</li> </ul> Do not hesitate to apply if you have: <ul> <li>Bachelor's degree in science, pharmacy, regulatory affairs.</li> <li>1 to 2 years in regulatory affairs and cosmetic industry, preferably in retail or FMCG.</li> <li>Proficiency in planning tools (RELEX, SAP, Oracle, etc.) and Microsoft Excel/Power BI.</li> <li>Strong communication, cross-functional collaboration, and stakeholder management.</li> <li>Data input, Ownership & Execution Focus.</li> </ul> Here, you will find: <ul> <li>Community. In which authenticity is embraced, and the strength of our differences fuels our collective spirit.</li> <li>Culture of Empowerment. Learning & growth, that offers you the tools, space and opportunity to learn, innovate and lead.</li> <li>Work that Brings Fulfilment. From delighting clients every day, to inspiring our industry at large, every action makes a difference.</li> </ul> Join us and belong to something beautiful Seniority level <ul> <li>Internship</li> </ul> Employment type <ul> <li>Internship</li> </ul> Job function <ul> <li>Quality Assurance, Supply Chain, and Accounting/Auditing</li> </ul> Industries <ul> <li>Retail Apparel and Fashion, Retail Luxury Goods and Jewelry, and Retail</li> </ul><img src="https://www.jobg8.com/Tracking.aspx?2BLAx2Vk0CYck5gk%2fUkgz11tC%2bGacsqdg" width="0" height="0" />

Regulatory Affairs Trainee

<div>
 
 
 Reporting to:
 
 Compliance &amp; Master Data Director
 
 
 
 Location:
 
 Dubai, United Arab Emirates
 
 
 
 
 
 At Sephora, beauty is about feeling seen, valued, and empowered, individually and collectively. It is connecting deeply with others, celebrating diversity and inclusivity, unlocking your potential and making a difference every day. Together, we belong to something beautiful.
 
 
 
 
 
 Since its inception in 1969 in Limoges, France, and as part of the LVMH Group since 1997, Sephora has been disrupting the prestige beauty retail industry. Today, Sephora continues to break with convention to drive its mission: champion a world of inspiration and inclusion where everyone can celebrate their beauty.
 
 
 
 
 
 With 56,000 employees in 35 countries, we connect customers and beauty brands within the world&rsquo;s most passionate beauty community. With a curation of nearly 500 brands, and our own label, Sephora Collection, we offer the most unique and diverse range of products: fragrances, makeup, hair care, skincare... and much more.
 
 
 
 
 
 
 You will excel and enjoy this position if you are ready to actively handle the following missions:
 
 
 <ul>
 <li>
 To enter data from various source documents into the computer system for processing, here on the Authorities online system related to suppliers and products.
 </li>
 <li>
 Notification of Sephora Own Brand and Exclusive brands- prepares source data for computer entry by compiling and sorting information from regulatory documents such as ingredients lists / excel sheets prepared by the brands.
 </li>
 <li>
 Establishing entry priorities from brands and suppliers.
 </li>
 <li>
 Enters data in the online systems by inputting alphabetic and numeric information on keyboard according to screen format of the online system.
 </li>
 <li>
 Maintains data entry requirements/complies with data integrity.
 </li>
 <li>
 Check completed work for accuracy.
 </li>
 <li>
 Lead times for product notifications.
 </li>
 <li>
 Store completed documents in designed locations.
 </li>
 <li>
 Maintain the registration tracking files with certificates numbers and validity dates.
 </li>
 <li>
 Help and Support on the labelling Back and Forth exchanges with the brands and creation of artworks.
 </li>
 </ul>
 
 
 
 
 
 Do not hesitate to apply if you have:
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in science, pharmacy, regulatory affairs.
 </li>
 <li>
 1 to 2 years in regulatory affairs and cosmetic industry, preferably in retail or FMCG.
 </li>
 <li>
 Proficiency in planning tools (RELEX, SAP, Oracle, etc.) and Microsoft Excel/Power BI.
 </li>
 <li>
 Strong communication, cross-functional collaboration, and stakeholder management.
 </li>
 <li>
 Data input, Ownership &amp; Execution Focus.
 </li>
 <li>
 Collaborative Communication.
 </li>
 </ul>
 
 
 
 
 
 Here, you will find:
 
 
 <ul>
 <li>
 
 Community.
 
 In which authenticity is embraced, and the strength of our differences fuels our collective spirit.
 </li>
 <li>
 
 Culture of Empowerment
 
 . Learning &amp; growth, that offers you the tools, space and opportunity to learn, innovate and lead.
 </li>
 <li>
 
 Work that Brings Fulfilment.
 
 From delighting clients every day, to inspiring our industry at large, every action makes a difference.
 </li>
 </ul>
 
 
 
 
 
 Join us and belong to something beautiful
 
 
 
 
</div>

Valencia Technologies

<div>Position/Title: Post-Market Analyst
Department: Quality Assurance
Supervisor: Quality Systems Specialist
FLSA Status: Exempt
About the Company: Valencia Technologies is a neuromodulation company transforming the standard of care for urgency urinary incontinence with the development of our revolutionary eCoin technology. Valencia Technologies is ramping up all aspects of business to deliver effective therapy and impact the lives of millions. Join our mission to become the market leader in overactive bladder care as we bring patients and physicians a better therapy now and beyond, put patients first, and be a place of respect, excellence, and honesty for our employees and clients.
Job Summary: The Post Market Analyst is responsible for maintaining the VTC complaint system, as well as performing an analysis/trending of complaint data, and driving quality improvements to address customer complaints.
Responsibilities/Tasks: As the Post-Market Analyst, you will be responsible for:<ul><li>Ensure that complaints are accurately, concisely, and appropriately captured in the VTC complaint system.</li><li>Process the complaints according to established complaint procedures. This includes determining of a reported issue is an actual complaint, ensuring complaints are thoroughly investigated, and ensuring complaints are closed in a timely and compliant manner.</li><li>Review customer complaints, determine reportability based on regulatory standards, and categorize complaints according to severity and potential safety concerns.</li><li>Analyze complaint data to identify trends, patterns, and potential safety signals, including using statistical methods to assess the significance of findings.</li><li>Prepare and submit necessary regulatory reports to relevant authorities like the FDA, including Medical Device Reports (MDRs) and Vigilance Reports, ensuring timely and accurate reporting.</li><li>Train new employees on the complaint process and the complaint system</li><li>Collaborate with other departments like customer service, engineering, and sales to gather information, share findings, and implement corrective actions.</li><li>Other duties as assigned</li></ul>
Qualifications:<ul><li>Bachelor's degree</li><li>Excellent attention to detail and critical thinking skills</li><li>Understanding of relevant regulatory standards (e.g., FDA QSR Part 820, ISO 13485)</li><li>Experience with complaint handling systems is desirable</li><li>Excellent analytical and problem-solving skills</li><li>Strong written and verbal communication skills to effectively document findings and communicate with stakeholders</li><li>Proficiency in Microsoft Office Suite, particularly Excel &amp; Access</li></ul>
Benefits:<ul><li>
Medical Insurance</li><li>
Dental Insurance</li><li>
Vision Insurance</li><li>
401K with Employer Matching</li><li>
Paid Time Off</li><li>
Paid Holidays</li><li>
Professional Development Reimbursement</li><li>
Annual Bonus Eligibility</li></ul>
Valencia Technologies is proud to be an equal opportunity workplace and is an affirmative action employer</div>

Post-Market Analyst

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