regulatory affairs officer

Transmed

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 Transmed Turkiye is a full-service distributor company across 13 countries, managing distribution, sales, and marketing for 35 leading brands. We strongly believe in putting people first &ndash; our customers, our teams, our partners.
 
 
 We are seeking a
 
 Regulatory Affairs Officer
 
 .
 
 
 
 Responsibilities
 
 
 
 
 JOB DESCRIPTION:
 
 
 
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 Conducting preliminary evaluations of imported and planned-to-be-imported products for compliance with local and international regulations,
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 Managing the regulatory approval processes for food, food supplements, cosmetics, cleaning products, and animal-origin products,
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 Following up on official correspondence with the Ministry of Agriculture and Forestry, Ministry of Health, and Ministry of Environment, Urbanization and Climate Change,
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 Registering and archiving products in the relevant ministry systems (e.g., GGBS, HBS),
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 Continuously monitoring regulatory updates and inform relevant departments in a timely manner,
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 Managing the follow-up and renewal processes of supplier quality certificates,
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 Collaborating with Demand Planning, Category, and Business Development teams during new product launches,
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 Working in cooperation with consultancy firms during permit and approval processes.
 
 
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 Qualifications
 
 
 
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 This position does not offer a hybrid / remote option.
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 Bachelor&rsquo;s Degree in Food Engineering or in a related field,
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 Minimum 2 years of experience in regulatory affairs for food, non-food, and cosmetic products,
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 Preferably experienced in regulatory processes at consultancy or import companies,
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 Advanced MS Office skills,
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 Proficient in English,
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 Proactive in following regulations, detail and result-oriented,
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 Strong communication skills and a good team player,
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 Completed military service for male candidates.
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 </ul>
</div>

Regulatory Affairs Officer

MBHHC

<ul><li>Bachelor&rsquo;s degree in Pharmacy, Biotechnology, Chemistry, or a related field</li><li>Postgraduate qualification or certification in Regulatory Affairs (preferred)</li><li>Knowledge of national and international regulatory guidelines (e.g., drug, medical device, or cosmetic regulations)</li><li>Familiarity with regulatory authorities and submission processes</li><li>Training in Good Regulatory Practices (GRP), GMP, or GDP is an advantage</li></ul>Technical &amp; Professional Skills<ul><li>Preparation, review, and submission of regulatory dossiers</li><li>Experience with product registration, renewal, and variations</li><li>Understanding of labeling, artwork, and packaging compliance</li><li>Ability to interpret regulatory laws, guidelines, and updates</li><li>Documentation management and regulatory tracking systems</li><li>Coordination with internal departments and external authorities</li></ul>Job Type: Full-timePay: QAR6,000.00 - QAR10,000.00 per monthEducation:<ul><li>Bachelor's (Preferred)</li></ul>Experience:<ul><li>Same role: 2 years (Preferred)</li></ul>License/Certification:<ul><li>QCHP (Preferred)</li></ul>

Registration and Regulatory Affairs Officer

Protectol Health

<div>
 
 Job Summary:
 
 
 We are seeking an experienced and detail-oriented Regulatory Affairs Officer to join our team in Oman. The ideal candidate will be responsible for managing regulatory submissions, ensuring product compliance with local health authority regulations, and maintaining up-to-date knowledge of evolving regulatory requirements, particularly with the Oman Ministry of Health (MOH).
 
 
 
 
 
 
 
 Key Responsibilities:
 
 
 
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 Prepare, compile, and submit product registration dossiers to the Oman Ministry of Health and other relevant regulatory bodies.
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 Maintain current knowledge of regulations, guidelines, and standards relevant to pharmaceutical, medical device, or healthcare product registration in Oman.
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 Ensure timely renewals, variations, and updates of licenses and product registrations.
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 Liaise with internal departments (Quality, Manufacturing, R&amp;D) to gather technical documents and support regulatory submissions.
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 Communicate and coordinate with regulatory authorities to ensure smooth submission processes and resolve any queries.
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 Monitor post-market regulatory requirements, including adverse event reporting, labeling compliance, and batch notification.
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 Track and maintain accurate records of all regulatory activities and ensure compliance documentation is up to date.
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 Support internal and external audits and inspections.
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 </ul>
 
 
 
 
 Requirements:
 
 <ul>
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 Bachelor's degree in pharmacy, Life Sciences, or a related field (master&rsquo;s preferred).
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 Minimum 5 years of experience in Regulatory Affairs within the pharmaceutical, medical device, or healthcare sector.
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 Strong knowledge of Oman MOH regulations and submission processes.
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 Oman MOH License preferred.
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 Excellent written and verbal communication skills in English (Arabic is an advantage).
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 Strong organizational skills, attention to detail, and the ability to manage multiple projects.
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 Proficient in MS Office applications and regulatory databases.
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 </ul>
</div>

Regulatory Affairs Executive

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

Viatris

<div>
 
 At VIATRIS&trade;, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
 
 
 
 
 
 Viatris empowers people worldwide to live healthier at every stage of life.
 
 
 
 
 
 We do so via:
 
 
 
 
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 Access
 
 &ndash; Providing high quality trusted medicines regardless of geography or circumstance.
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 Leadership
 
 &ndash; Advancing sustainable operations and innovative solutions to improve patient health; and
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 Partnership
 
 &ndash; Leveraging our collective expertise to connect people to products and services.
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 Every day, we rise to the challenge to make a difference and here&rsquo;s how the (Regulatory Affairs Senior Associate) role will make an impact:
 
 
 
 
 
 
 Key responsibilities for this role include:
 
 
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 Support the local regulatory team in the development of regulatory strategies to support the registration of new products, line extensions, major variations, and lifecycle management.
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 Develop strong partnerships with in-country and above country teams to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.
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 Responsible for enhancing relationships with key external agencies (Egyptian Drug authority EDA). Manage the EDA interface throughout the development and lifecycle of a product.
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 Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP&rsquo;s and systems are followed.
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 Ensure a submission planning and forecasting tool is utilized to update timelines, when necessary, communicate changes to relevant partners.
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 Capable of authoring some local submission components in relevant databases.
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 Ensure submission packages are reviewed against local CMC requirements for consistency and completeness.
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 Liaise with the manufacturing sites for obtaining supporting documents as needed.
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 Participate in local and regional regulatory initiatives promoting a culture aligned with Viatris values and which supports compliance, innovation and talent development and retention.
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 Maintain compliance with the regulatory systems, processes and procedures.
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 The minimum qualifications for this role are:
 
 
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 2-3 years of experience in regulatory affairs, preferably in human medicines.
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 Demonstrate regulatory experience with a pharmaceutical company with proven examples of contribution.
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 Proven ability to manage Regulatory issues and consistently deliver to time, cost and quality standards.
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 Demonstrate experience of effective delivery in a matrix environment.
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 Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks.
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 Knowledge of drug development, regulations, and guidelines.
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 Knowledge and understanding of quality systems and processes.
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 Ability to influence peers in the organization.
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 Team player.
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 Act independently with less supervision.
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 Analytical thinking.
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 At Viatris, we offer competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
 
</div>

Regulatory Affairs Senior Associate

Snibe

<div>
 
 
 Key Responsibilities:
 
 
 
 * DRAP registration of IVD kits and analyzers
 
 
 * Renewal, variation, and post registration submissions
 
 
 * Review of IFU, labels, and artwork
 
 
 * Response to DRAP observations and regulatory correspondence
 
 
 
 
 
 
 Requirements:
 
 
 
 
 1.Education (HEC recognized):
 
 
 
 * Doctor of Pharmacy (Pharm D)
 
 
 * Bachelor of Pharmacy (B Pharm)
 
 
 * MPhil in Medical Sciences, Biochemistry, or Pharmaceutical Sciences
 
 
 
 
 
 
 2.Professional Registration:
 
 
 
 * Valid Pharmacy Council registration (mandatory for Pharm D and B Pharm)
 
 
 
 
 
 
 3.Experience:
 
 
 
 * Minimum 3 years experience in regulatory affairs
 
 
 * Hands on experience with IVD, immunoassay, and clinical chemistry product portfolios, including diagnostic kits, analyzers, and reagents
 
 
 
 
 
 
 4.Skills:
 
 
 
 * Strong knowledge of DRAP IVD regulations
 
 
 * Good written English and documentation skills
 
 
 * Ability to manage multiple registrations independently
 
 
 
 
 
 
 Work location:
 
 
 
 Islamabad (Close coordination with DRAP HQ)
 
 
 
</div>

Regulatory Affairs Specialist-Pakistan

Perrigo Company plc

<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.
 
 
 
 Description Overview
 
 
 
 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.
 
 
 
 Scope of the Role
 
 
 
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 Support in the management of change by preparing applications and technical files in support of existing commercial product regulatory maintenance;
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 Support in the regulatory activities on new product development (NPD), including artwork approvals, label claims and associated supporting documentation;
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 Develop and approve label specifications (master text and local artwork text) in compliance with SOPs, as well as promotional materials from a regulatory perspective;
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 Maintain regulatory files and data systems in compliance with SOPs;
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 Represent regulatory affairs in project meetings with both Perrigo staff and external contacts;
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 Follow up on changes in (inter)national regulations and legislations, and support in the interpretation, communication and implementation;
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 Liaise with Corporate Regulatory, responding to regulatory queries and providing and review of registration documents as necessary for the Turkish and/or European territory;
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 Support in the communication with local regulatory authorities regarding license applications and notice of change.
 
 
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 </ul>
 
 Experience Required
 
 
 
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 University Degree in a Scientific Subject;
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 Minimum of 2 years work experience within Regulatory Affairs required, within at least one of the following categories Medical Devices, Biocides, Cosmetics and Medicines;
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 Excellent communicator in Turkish and English;
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 Proficient computer skills esp. Microsoft (word, excel, powerpoint); experience with Veeva, TVT, Trackwise is an asset;
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 Eye for detail, punctual, well organized;
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 Being flexible and adaptable to change;
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 Ability to support several concurrent projects/products simultaneously;
 
 
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 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 "America's Best Employers by State 2024". 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

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