regulatory affairs consultant

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)

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>

IQVIA

No visa or accommodation sponsorshipYou will be responsible for regulatory activities required at a country level for pharmaceutical products including maintenance and approvals, marketing authorization transfers, communication with the Health Authority, artwork approval, etc., ensuring regulatory compliance in the applicable market(s).As part of the IQVIA Global Regulatory Affairs department, you will be working with our clients, global pharmaceutical companies.JOB OVERVIEWEssential Functions<ol><li>Manage the local regulatory submission preparation in collaboration with internal and external stakeholders based on the agreed strategy for designated countries.</li><li>Submit submissions such as renewals, variations, new applications, filings, MAH transfers to the local Health Authority and EMA, and follow up on the local regulatory approval process for designated countries.</li><li>Preparation of local Product Labelling (e.g., SmPC, PIL) in local language for designated countries.</li><li>Artwork review and approval in client systems.</li><li>Manage multiple pharmaceutical products.</li><li>Act as subject matter expert in regulatory processes.</li><li>Acts as a Regulatory Team Leader on more complex projects which may include authoring of regulatory documentation and filling application forms.</li><li>Establishes relationships with customers; may meet face to face to discuss regulatory issues, present lessons learned, and discuss customer comments.</li><li>Acts as a Subject Matter Expert in Regulatory knowledge in Chemistry Manufacturing and Controls or Lifecycle Maintenance / Marketing Authorization Transfers/ Labeling/ Publishing.</li><li>Project budget management.</li><li>Give guidance to junior colleagues including feedback on the quality of technical documents and may assist in their training and development.</li><li>Possible exposure to present to clients on complex regulatory processes and bid defense meetings.</li><li>Act as reviewer for regulatory standard operating procedures.</li><li>Prepare and deliver internal regulatory training if required.</li></ol>MINIMUM REQUIRED EDUCATION AND EXPERIENCEExperience: Typically requires 8-10 years of prior relevant experience.Education: Masters Degree in Life Sciences or related discipline.Skills and Abilities:<ul><li>Good understanding of the Research and Development process (Chemistry Manufacturing & Controls) relevant regulatory guidelines.</li><li>Possesses specific regulatory or technical expertise.</li><li>Interpersonal communication (oral and written) and organization skills.</li><li>Ability to establish and maintain effective working relationships with coworkers, managers, and clients.</li><li>Demonstrates self-motivation and enthusiasm.</li><li>Ability to adapt quickly to a rapidly changing environment.</li><li>Knowledge of Maintenance of Marketing Authorization.</li><li>Experience of preparing variation renewal packages and artwork approvals.</li><li>Fluent in English and able to effectively communicate complex business language to those who speak English as a second language.</li><li>Must be fluent in Arabic.</li></ul>IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world. Learn more at<img src="https://www.jobg8.com/Tracking.aspx?%2fh34g3pSz%2f5vcg4ahaTk8lEKzSlsbq%2f%2bp" width="0" height="0" />

Global Regulatory Affairs Manager homebased

ANRA Technologies

Overview ANRA Technologies is seeking a Stakeholder Engagement and Regulatory Expert to support a strategic aviation project in the UAE in collaboration with DAEP, DANS, and the local civil aviation authority, alongside other civil and military airspace stakeholders. This is a dual-role position responsible for managing stakeholder engagement across government, regulatory, and operational bodies, while also providing technical regulatory guidance and compliance support for the project's successful execution. The ideal candidate will have a strong background in aviation regulation - particularly in U-space, UTM, and drone operations - with experience in working alongside both civil and military aviation authorities.Employment: Project-Based On-SiteCity: Dubai, United Arab EmiratesSchedule: Full TimeExperience: Min 7 yearsAbout ANRA: ANRA Technologies, with offices in Washington DC, London, New Delhi and Estonia, is an international provider of drone operations and traffic management solutions for unmanned aircraft systems (UAS) operators and airspace managers. We offer intelligent Machine Learning and AI driven traffic management software capabilities for UAS Traffic Management (UTM) and Urban Air Mobility (UAM) operations. Key Responsibilities <ul><li>Act as ANRA's primary liaison with the General Civil Aviation Authority (GCAA) and other relevant stakeholders including DAEP, DANS, defense entities, and airport operators</li><li>Build and maintain strong working relationships with civil and military authorities, attending coordination meetings and facilitating productive dialogue</li><li>Represent ANRA in stakeholder engagements, working groups, and regulatory consultations</li><li>Support joint planning sessions, workshops, and status reviews, ensuring alignment between technical teams and stakeholder expectations</li><li>Manage formal and informal communications with key government and regulatory counterparts</li></ul> Regulatory Support <ul><li>Provide regulatory interpretation and guidance for UTM/U-space implementation, including compliance with local drone regulations and airspace rules</li><li>Contribute to the development and submission of required documentation, such as Concept of Operations (ConOps), Letters of Agreement (LoA), safety assessments, and operational approvals</li><li>Track and interpret evolving UAE regulatory policies and frameworks, offering strategic input on how they impact project implementation</li><li>Coordinate with internal teams to ensure solution deployment aligns with applicable aviation, data protection, and cybersecurity regulations</li><li>Support the development of regulatory briefings, reports, and decision memos for internal and external stakeholders</li></ul> Required Qualifications <ul><li>Bachelor's or Master's degree in Aviation, Aerospace Engineering, Air Traffic Management, or related field</li><li>Minimum of 7 years of experience in the aviation industry with a focus on regulatory affairs, UTM/U-space, or air traffic management</li><li>Prior experience working with or liaising with civil aviation authorities, air navigation service providers, or defense entities in the UAE or GCC region</li><li>Deep knowledge of drone operations, U-space/UTM regulations, and manned aviation procedures</li><li>Strong stakeholder management and negotiation skills, especially in multicultural and high-level regulatory environments</li><li>Familiarity with international frameworks (e.g., ICAO, EASA, GCAA) and national regulatory processes</li><li>Excellent written and verbal communication skills</li></ul> Preferred Attributes <ul><li>Prior experience supporting aviation projects in the UAE or Middle East</li><li>Arabic language proficiency is a plus</li><li>Certification or training in aviation regulation, risk assessment, or safety management systems (SMS) is advantageous</li><li>Understanding of airspace modernization, C2/C3 frameworks, or joint civil-military operations</li></ul> What We Offer <ul><li>Competitive compensation and local benefits package</li><li>Opportunity to lead stakeholder engagement for a first-of-its-kind UTM/U-space project in the region</li><li>Exposure to high-impact aviation innovation in collaboration with major UAE aviation authorities</li><li>A dynamic, hands-on, and collaborative environment within a fast-paced global aviation software company</li></ul><img src="https://www.jobg8.com/Tracking.aspx?cVAb9OF4hnpBEW1GShW07%2fUTjwp%2brOYUz" width="0" height="0" />

Stakeholder Engagement and Regulatory Expert

Yordas Group

<div><h3 class="jobSectionHeader">Description</h3><div> 
Yordas Group is a leading international provider of scientific and consultancy services, regulatory advice and training to industry in sustainability, chemicals management and risk assessment. We help ensure companies are compliant and up-to-date with the regulations affecting their supply chains and product portfolios. Yordas is headquartered in the UK, with offices and representation across the globe.</div><div>
 
Job title: Associate Consultant</div><div>
Grade: Associate</div><div>
Location: Lancaster / Remote UK, Remote Canada, Remote Turkey, Remote Bulgaria</div><div>
 
Summary</div><div> 
</div><div>
We are looking for an Associate Consultant to join our growing Global Regulatory Data team.</div><div>
As a member of the Global Regulatory Data team, the successful candidate will undertake client-driven activities in one or more of the Yordas Global Regulatory Data service areas, including:</div><ul>
<li>Monitoring and researching of global chemicals regulations</li>
<li>Providing consultancy services to clients</li>
<li>Preparation and submission of dossiers to the EU SCIP database</li>
<li>Maintaining chemical databases including for our software Yordas Helix</li>
<li>Scripting regulatory summaries and impact assessments</li>
<li>Supporting the delivery of client projects</li></ul> 
<h3 class="jobSectionHeader">
Roles and Responsibilities</h3><div> 
Candidates would provide support on:</div><ul>
<li>Regulatory data compilation and management</li>
<li>Delivery of technical services and consultancy</li>
<li>Liaising with internal divisions to ensure client needs are fulfilled effectively</li>
<li>Project management and client liaison</li>
<li>Presenting to prospective clients and at industry</li>
<li>Building client relationships and scripting proposals and quotations</li></ul> 
<h3 class="jobSectionHeader">
Profile and Qualifications</h3><div> 
Essential:</div><ul>
<li>A degree in a STEM (Science, Technology, Engineering, Mathematics) discipline would be preferred or any degree which provides skills of research, analytical thinking, strong written communication and creative problem solving.</li>
<li>Excellent written and verbal communication skills</li>
<li>Logical and analytical with the ability to solve problems quickly</li>
<li>Ability to turn round work efficiently and to a high standard with excellent attention to detail</li>
<li>Good at working well on your own and as part of a growing dynamic team</li>
<li>Ability to successfully manage a fluctuating workload and work well under pressure</li>
</ul><div>Desirable:</div><ul>
<li>Experience with interpretation of chemicals legislation</li>
<li>Experience with client-driven work in a commercial setting</li>
<li>Experience with databases or with managing large datasets</li>
<li>Strong interpersonal skills and an ability to build rapport with clients</li></ul> 
<h3 class="jobSectionHeader">
Staff Benefits</h3><div> 
Dependent on location, we offer an excellent range of staff benefits, including:</div><ul>
<li>Pension Scheme and Medical Benefits</li>
<li>Generous holidays</li>
<li>Professional Development</li>
<li>Social Culture</li>
<li>Flexible working</li></ul> 
<h3 class="jobSectionHeader">
About Yordas Group</h3><div>
 
Yordas Group is a leading provider of scientific, environmental, human health, and global regulatory consulting services. We offer chemical regulatory support, expert scientific services and support on chemicals management and product stewardship, global hazard communication, hazard and risk assessment, analytical and (eco)tox testing. 
 
Our international client base includes chemical producers, manufacturers, formulators, importers, distributors, retailers as well as trade associations. Yordas serves various industry sectors such as Aerospace, Biocides, Cleaning, Electronics, Lubricants, Nanomaterials, Oil, Gas &amp; Mining, Plastics or Textiles. 
 
We are an equal opportunity employer and welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation, gender reassignment or age. 
 
Yordas Group embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.</div></div><div></div>

Associate Consultant - Global Regulatory Data

S.S. Industries

Details of the requirement are given below for your reference:1) Client Company : Pharmaceuticals Industry 2) Position : Regulatory Affairs 3) Experience Required : 3+ years 4) Salary Negotiable : Rs. 20000 PM to 50000 PM 5) Job Location : Ahmedabad 6) Job Description :A) To review dossier prepared by executives and trainees and submit to client along with artworks for countries like ASIA, LATAM &amp; ROW Market.B) To work on Renewals of Registration Certificate for countries.C) Ensure that a companys products comply as per current ICH and Country Guidelines. D) Courier of Legalized Documents such as COPP, FSC, POA, ManufacturingAgreement, Declaration letters for updation of artworks, GMP certificate to respective clients and countries.E) Courier of Samples for New registration and Renewal Purpose as per client requirements for reanalysis and first commercial batch analysis purpose.F) Arrangement of Sample and Legals required as per new registration and Renewal purpose from Legal team, Production department and FRD.G) Follow up with FRD and Microbiology department for test requirements by client on batch FPCOA.H) Arrangement and courier of Working Standards from QC department to Client or country as required for testing purpose.I) Resolving queries from client regarding new registration and renewals as per country requirements.J) Updation and maintenance of Country Specific Global Status sheets for New registration, Renewals and Query Status.K) Follow up for Review and corrections of Artworks required for New registration and Renewals with Artwork department as per client and company requirements.L) Follow up and arrangements of Documents required for Dossier Preparation with QA, QC, ARD and Micro Department as per country guidelines.Interested candidates can apply immediately.With Regards, Gopi (HR) 7777981967 - gopi.ssindustries04@gmail.comJob Type: PermanentPay: &#8377;20,000.00 - &#8377;49,276.02 per monthWork Location: In person

Regulatory Affairs - Pharmaceuticals - Ahmedabad

Search 10000+ Regulatory affairs consultant jobs near you this October. New roles added regularly across leading industries. Apply today.

10000 regulatory affairs consultant jobs NEAR_ME

Regulatory Affairs Associate - (Fixed Term Maternity Cover)

Regulatory Affairs Trainee

Regulatory Affairs Trainee

Global Regulatory Affairs Manager homebased

Stakeholder Engagement and Regulatory Expert

Associate Consultant - Global Regulatory Data

Regulatory Affairs - Pharmaceuticals - Ahmedabad