regulatory affairs associate

Perrigo

<div>At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill&reg;, Compeed&reg;, Solpadeine&reg;, NiQuitin&reg;, ACO&reg;, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. 
Join us on our One Perrigo journey as we evolve to win in self-care.<div><div><div><h2 class="jobSectionHeader"> 
Description Overview</h2></div><div>
In this role you will be responsible for the hands on regulatory activities required to maintain existing commercial products, and support in making correct and timely new product applications of Perrigo products on the Turkish market. You will support to ensure compliance with the existing legislation for Medicines, Medical Devices, Biocides and Cosmetics. Another key aspect of the role will be supporting in the achievement of the overall Regulatory, Quality &amp; Safety objectives and timely realization of operational activities. In this position you collaborate closely with the Corporate Regulatory and Turkish Commercial colleagues to strive to help the customer the best.</div></div><div><div><h2 class="jobSectionHeader">
Scope of the Role</h2></div><div><ul><li>
Support in the management of change by preparing applications and technical files in support of existing commercial product regulatory maintenance;</li><li>
Support in the regulatory activities on new product development (NPD), including artwork approvals, label claims and associated supporting documentation;</li><li>
Develop and approve label specifications (master text and local artwork text) in compliance with SOPs, as well as promotional materials from a regulatory perspective;</li><li>
Maintain regulatory files and data systems in compliance with SOPs;</li><li>
Represent regulatory affairs in project meetings with both Perrigo staff and external contacts;</li><li>
Follow up on changes in (inter)national regulations and legislations, and support in the interpretation, communication and implementation;</li><li>
Liaise with Corporate Regulatory, responding to regulatory queries and providing and review of registration documents as necessary for the Turkish and/or European territory;</li><li>
Support in the communication with local regulatory authorities regarding license applications and notice of change.</li></ul></div></div><div><div><h2 class="jobSectionHeader">
Experience Required</h2></div><div><ul><li>
University Degree in a Scientific Subject;</li><li>
Minimum of 2 years work experience within Regulatory Affairs required, within at least one of the following categories Medical Devices, Biocides, Cosmetics and Medicines;</li><li>
Excellent communicator in Turkish and English;</li><li>
Proficient computer skills esp. Microsoft (word, excel, powerpoint); experience with Veeva, TVT, Trackwise is an asset;</li><li>
Eye for detail, punctual, well organized;</li><li>
Being flexible and adaptable to change;</li><li>
Ability to support several concurrent projects/products simultaneously;</li></ul></div></div></div>
Benefits 
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.
Find out more about Total Rewards at Perrigo. 
Hybrid Working Approach 
We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles. 
We are proud to be included in the Forbes list of &quot;America's Best Employers by State 2024&quot;. Find out more here 
Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you. 
We are 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, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo</div>

Regulatory Affairs, Associate Specialist

Safeway

<div><div>Prior to applying it is required that you inform your manager of your desire to post for a new position.
Why choose us?
Are you ready to take the next step in your career? Join us for an exciting opportunity at Albertsons Companies, where innovation and customer service go hand-in-hand!
At Albertsons Companies, we are looking for someone who&rsquo;s not just seeking a job, but someone who wants to make an impact. In this role, you&rsquo;ll have the opportunity to lead, innovate, and contribute to the growth of a company that values great service and lasting customer relationships. This position offers the chance to work in a fast-paced, dynamic environment that&rsquo;s constantly evolving.
Main responsibilities:
As part of the Regulatory Affairs team, the Senior RA Associate will be responsible for ensuring faultless compliance of product labeling for several brands within the Albertsons Own Brands. Interact regularly with many other functions including but not limited to Product Development, Food Safety and Quality, Product Management, Sourcing, and Legal. Conduct daily regulatory activities related to product development such as identification, interpretation, and implementation of all applicable federal, state and local regulations. These include but are not limited to standards of identity, package label requirements, claims identification and validation, preparation and submission of USDA label approval requests and records preparation and retention to comply with regulatory requirements. These activities include oversight and review of regulatory activities for in house developed and manufactured products and regulatory activities conducted by contract manufacturers of consumer brands products. This position is critical to ensuring regulatory compliance and avoidance of the product retrievals and recalls that can result from noncompliance to product and package regulations.
<ul><li>Provide regulatory expertise on cross functional project teams for the Own Brands categories assigned to them and ensure all consumer brands packaging is in compliance with federal, state and local regulations. This involves daily interactions with marketing, graphic design, sourcing and outside design agencies to ensure that all existing, new and revised packaging graphics and placements are in compliance with labeling regulations.</li>
<li>Create Label copy with ingredient statements, nutrition facts, substantiating complex claims and approving graphics and ensuring the accuracy of the regulatory information in Albertsons databases, on final artwork and in specifications. This interaction is required from the beginning of the design process to review of final artwork prior to package production.</li>
<li>Lead RA taskforce for various state regulation impacting the products in Own Brands portfolio</li>
<li>Support commercialization process and ensure timely execution of regulatory related tasks&ndash; including co-packer and self-manufactured product label copy review, claims substantiation, maintenance of Checklists, Consumer Brands Style Guide and SOPs. Provide input on nutrition labeling, defining new claim territories and managing packaging timelines.</li>
<li>Lead compliance systems requirements and testing, RA Manual updates and continuous improvement initiatives for the RA team as part of the RA core team</li>
<li>Partner with cross functional team members including PD, SI and Legal in partnership with the RA manager to develop guardrails for competitive claims as the Subject Matter Expert (SME) to support food and non-food products in new and competitive claims space</li>
<li>Require an excellent understanding and application of US labeling regulations (USDA, FDA, EPA) to assure the accuracy of ingredient statements, nutrition facts, allergen declarations and claims.</li>
<li>Ability to think strategically as well as independently monitor, interpret and ensure compliance with US regulations today and into the future.</li>
<li>Prepare regulatory training materials for labeling, claims, regulatory systems, and certifications and presenting to OB Technical Services and category teams</li>
<li>Responsible for onboarding new Regulatory Affairs (RA) team members and cross-training within Technical Services team</li>
</ul>We are looking for candidates who possess the following:
<ul><li>Bachelor&rsquo;s degree in food science or related field</li>
<li>Minimum of 5 years combined regulatory affairs, compliance, product development, nutrition or technical related experience required, with strong knowledge of FDA and USDA food regulations.</li>
<li>Proven knowledge with consumer-packaged goods labeling experience.</li>
<li>Proficiency working with regulatory on labeling, product development on formulation requirements, marketing and graphics design personnel on package graphics.</li>
<li>Must have strong written and verbal communication skills and ability to prioritize multiple projects across multiple categories with competing timelines.</li>
<li>Strong sense of urgency, time management, and commitment to meet aggressive timelines.</li>
<li>Must be comfortable with asking questions and having direct discussions of project requirements with peers, supervisors, and product development personnel up to the VP level.</li>
<li>Ability to think both strategically and tactically and have experience in project management, multi-tasking, meeting tight deadlines and shifting work focus based on shifting business and technical priorities.</li>
<li>Excellent computer skills and attention to detail, and experience with online specification systems.</li>
<li>Strong communication and organizational skills.</li>
<li>Must be able to communicate cross functionally between directors, managers, technical staff and vendor community daily.</li>
</ul>We also provide a variety of benefits including:
<ul><li>Competitive wages paid weekly</li>
<li>Associate discounts</li>
<li>Health and financial well-being benefits for eligible associates (Medical, Dental, 401k and more!)</li>
<li>Time off (vacation, holidays, sick pay). For eligibility requirements please visit myACI Benefits</li>
<li>Leaders invested in your training, career growth and development</li>
<li>An inclusive work environment with talented colleagues who reflect the communities we serve</li>
</ul>Our Values &ndash; Click below to view video: ACI Values
Base Salary Template Language (CA, CO, WA &amp; IL): The salary range is $72,100 to $93,640 annually. Starting salary will vary based on criteria such as location, experience, and qualifications. There may be flexibility for exceptional candidates.
A copy of the full job description can be made available to you.
#LI-JB2
</div>
Albertsons Companies is at the forefront of the revolution in retail. &amp;Committed to innovation and fostering a culture of belonging, our team is united with a unique purpose: to bring people together around the joys of food and to inspire well-being. &amp;We want talented individuals to be part of this journey! Locally great and nationally strong, Albertsons Companies (NYSE: ACI) is a leading food and drug retailer in the U.S.&amp; We operate over 2,200 stores, 1,732 pharmacies, 405 fuel centers, 22 distribution facilities, and 19 manufacturing plants across 34 states and the District of Columbia. Our well-known banners include Albertsons, Safeway, Vons, Jewel-Osco, ACME, Shaw&rsquo;s, Tom Thumb, United Supermarkets, United Express, Randalls, Albertson&rsquo;s Market, Pavilions, Star Markets, Market Street, Carrs, Haggen, Lucky, Amigos, Andronico&rsquo;s Community Markets, King&rsquo;s, Balducci&rsquo;s, and Albertson&rsquo;s Market Street. Our vision is to be a retail leader admired for national strength with deep local roots, offering an easy, fun, friendly, and inspiring experience, no matter how customers choose to shop with us. We celebrate the rich diversity of the communities we serve, and strive to create a workplace where everyone has equal access to opportunities and resources, and can fully contribute to their and our company&rsquo;s success. Bring your flavor Building the future of food and well-being starts with you. Join our team and bring your best self to the table. &amp; &amp; Disclaimer The above statements are intended to describe the general nature of work performed by the employees assigned to this job and are not the official job description for the position. All employees must comply with Company, Division, and Store policies and applicable laws. The responsibilities, duties, and skills of personnel may vary within store and/or from store to store and the official job description will be provided during the application process. Albertsons is an Equal Opportunity Employer This Company is an Equal Opportunity Employer, and does not discriminate on the basis of race, gender, ethnicity, religion, national origin, age, disability, veteran status, gender identity/expression, sexual orientation, or on any other basis prohibited by law. Consistent with applicable state and local law, the Company will consider for employment qualified applicants with arrest and conviction records.&amp; We endeavor to make this site accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact us at 1-888-255-2269(option #4).</div>

Senior Food Regulatory Affairs Associate

Associate III - Business Analysis

Amgen

Associate Regulatory Affairs - based in Dubai Join to apply for the Associate Regulatory Affairs - based in Dubai role at Amgen.You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. What You Will Do Let's do this. Let's change the world. In this vital role, you will manage country specific regulatory affairs for Amgen's molecules, coordinate and implement regulatory submissions, ensure compliance with corporate and local requirements and lead documentation for local submissions under Senior Manager's guidance:<ul><li>Ensures regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements</li><li>Reviews promotional and non promotional materials.</li><li>Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.</li><li>Partners with International Regulatory Leads (IRLs) and Global Regulatory Leads (GRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.</li><li>Partners with peers to ensure consistency on procedures.</li></ul> What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The Regulatory Affairs professional we seek is a teammate with these qualifications. Basic Qualifications <ul><li>Bachelor's degree in Pharmaceutical Science</li><li>Working with policies, procedures and SOPs.</li><li>Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.</li><li>Knowledge of the Gulf legislation and regulations.</li><li>Understanding of regulatory activities and how they impact other projects and/or processes.</li><li>Understanding of drug development.</li><li>Demonstrate ability to work in teams.</li><li>Ability to understand and communicate scientific/clinical information.</li></ul> Preferred Qualifications <ul><li>Regulatory experience of the Gulf Markets.</li><li>Knowledge of regional countries legislation and regulations relating to medicinal products in the Gulf Markets.</li><li>Experience interacting with regulatory agency in the Gulf markets.</li></ul> What You Can Expect Of Us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well being. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply now at Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Associate Regulatory Affairs - based in Dubai

Peergrowth Consultancy Co.

We are seeking a detail-oriented and proactive Regulatory Affairs Coordinator to support regulatory activities at our UAE-based manufacturing facility. This role is responsible for compiling and coordinating product and site-specific regulatory dossiers for submission to global health authorities, including support for GMP audits. The ideal candidate will collaborate closely with Quality Assurance (QA), manufacturing, and technical teams at the site, as well as regional regulatory teams. Experience with local UAE and GCC regulatory requirements is preferred, with an understanding of global CTD requirements.KEY RESPONSIBILITIES<ul><li>Collate, compile, and review regulatory dossiers for product and site registrations in various international markets, including GMP audit dossiers.</li><li>Ensure accuracy, completeness, and regulatory compliance of all documentation submitted.</li><li>Review and verify the correctness and regulatory alignment of Artwork (AW) prior to submission.</li><li>Act as a key liaison between regional regulatory teams and site-based technical functions (QA, QC, Production, Engineering).</li><li>Coordinate technical responses and ensure timely resolution of queries raised by health authorities during or post submission through regional RA teams.</li><li>Maintain an organized and up-to-date archive of all regulatory submissions made from the site.</li><li>Implement proper version control, submission tracking, and document retrieval protocols.</li><li>Monitor submission timelines and follow up with internal teams to ensure timely completion of deliverables.</li><li>Ensure alignment with both international regulatory expectations and local UAE / GCC requirements.</li><li>Provide regular status updates on submissions and queries to the Head of International Regulatory Affairs.</li><li>Support documentation requests for internal audits, inspections, and compliance reviews.</li></ul>CANDIDATE EXPERIENCE<ul><li>Bachelors or masters degree in pharmacy (preferred)</li><li>2 to5 years of experience in Regulatory Affairs, ideally in a manufacturing or site-based setting within the pharmaceutical industry.</li><li>Preferred : Experience with handling guidelines of UAE Ministry of Health (MoHAP), GCC-DR, Oman, Bahrain, or other Gulf regulatory bodies.</li><li>Practical knowledge of CTD / eCTD dossier formats and GMP audit preparation.</li></ul>Key Skills and Competencies<ul><li>Strong communication, collaboration, and coordination skills across technical and regulatory functions.</li><li>High level of accuracy, attention to detail, and document management capabilities.</li><li>Ability to manage multiple priorities, meet deadlines, and adapt to dynamic regulatory requirements.</li><li>Proficient in Microsoft Office (Word, Excel, PowerPoint) and document control systems.</li><li>Proactive approach to problem-solving and handling regulatory queries.</li></ul>Coordinator • Dubai, United Arab Emirates

Regulatory Affairs Coordinator

Amros Pharmaceuticals

Regulatory Affairs Officer.We seek a highly motivated individual with a Doctor of Pharmacy (PharmD) degree and 6 months to 1 year of experience in the pharmaceutical industry (Regulatory Affairs or a related function preferred).Key ResponsibilitiesAssist in compiling and submitting CTD/eCTD dossiers to health authorities.Support the coordination of responses to regulatory agency queries.Research and monitor global regulatory guidelines (ICH, FDA, EMA) for compliance.Maintain accurate regulatory documentation and archives.RequirementsPharmD degree.6-12 months of relevant pharma industry experience.Strong attention to detail and excellent communication skills.Job Type: Full-timeWork Location: In person

Regulatory Affairs Officer

Manpower Türkiye

<div>
 
 We are looking for a
 
 "Regulatory Affairs Assistant to Specialist"
 
 on behalf of a client to whom we provide consultancy services, operating in the hearing aids and medical equipment industry.
 
 
 
 
 
 
 Job Definition
 
 
 
 
 
 
 &bull; Support the preparation, review, and submission of regulatory documentation in compliance with local and international requirements.
 
 
 &bull; Assist in maintaining regulatory files and product registration databases.
 
 
 &bull; Support audit and inspection preparation activities as needed.
 
 
 &bull; Collaborate effectively with different business teams to ensure smooth regulatory processes and timely submissions.
 
 
 
 
 
 
 Qualifications
 
 
 
 
 
 
 &bull; Bachelor&rsquo;s degree in Pharmacy, Biomedical Engineering, Chemistry, Biology, or a related life sciences field.
 
 
 &bull; Up to 1 year of professional experience in Regulatory Affairs or related areas in medical device sector.
 
 
 &bull; Strong communication and coordination skills, with the ability to work effectively across departments.
 
 
 &bull; Excellent attention to detail and organizational skills.
 
 
 &bull; Fluency in English (both written and spoken) is required.
 
 
 &bull; Proficiency in MS Office applications.
 
 
 
 
 
 
 
 
 
 Please note that only the candidates that fulfill these requirements will be considered and shortlisted candidates will be contacted. LinkedIN &uuml;zerinden elektronik olarak iletece&gbreve;iniz ki&scedil;isel bilgileriniz, 6698 say&inodot;l&inodot; Ki&scedil;isel Verilerin Korunmas&inodot; Kanunu ve ilgili mevzuat &ccedil;er&ccedil;evesinde, Experis T&uuml;rkiye (Manpower Group T&uuml;rkiye) taraf&inodot;ndan yaln&inodot;zca &Scedil;irketimizden talep etti&gbreve;iniz hizmetlerin sunulabilmesi ve bu hizmetlerin s&uuml;reklili&gbreve;inin sa&gbreve;lanmas&inodot; ama&ccedil;lar&inodot;yla saklanabilecek, i&scedil;lenebilecek ve verilen servisin gerektirdi&gbreve;i hallerde yurti&ccedil;inde ve yurtd&inodot;&scedil;&inodot;nda yerle&scedil;ik 3. ki&scedil;ilerle payla&scedil;&inodot;labilecek olup, ki&scedil;isel verileriniz hi&ccedil;bir &scedil;ekilde hukuka ve d&uuml;r&uuml;stl&uuml;k kural&inodot;na ayk&inodot;r&inodot; &scedil;ekilde ba&scedil;kalar&inodot; ile payla&scedil;&inodot;lmayacak ve i&scedil;leme sebebi d&inodot;&scedil;&inodot;nda ba&scedil;ka ama&ccedil;larla kullan&inodot;lmayacakt&inodot;r. Ki&scedil;isel verileriniz yaln&inodot;zca i&scedil;leme amac&inodot;n&inodot;n gerekli k&inodot;ld&inodot;&gbreve;&inodot; s&uuml;re boyunca saklanacak olup talebiniz &uuml;zerine silinecek veya imha edilecektir. Detayl&inodot; bilgiye https://www.experis.com.tr/site/kisisel-verilerin-korunmasi/39 linkinden ula&scedil;abilirsiniz. Bu i&scedil;e ba&scedil;vurarak, &ouml;zge&ccedil;mi&scedil;inizin veritaban&inodot;m&inodot;zda yer almas&inodot;n&inodot; kabul etmi&scedil; oldu&gbreve;unuzu bildirmek isteriz.
 
 
 
 
</div>

Regulatory Affairs Assistant to Specialist

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