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We are looking for an experienced freelance Regulatory Affairs Specialist to support our company with the registration of medicinal products in European countries. The specialist will be expected to assist with the full registration process, including but not limited to: Preparation and review of registration dossiers Submission procedures for medicinal products Communication with regulatory authorities Support with variations, renewals, and lifecycle maintenance Compliance with EU regulatory requirements and guidelines Coordination of documentation and responses to authority questions Assistance with local regulatory procedures in different European markets Requirements: Proven experience in medicinal product registration in Europe Strong knowledge of EU pharmaceutical regulatory procedures Experience with CTD/eCTD documentation Ability to work independently and meet deadlines Excellent communication skills in English Experience with multiple European markets and different registration pathways will be considered an advantage. Please share your experience, countries/markets you are working with and prices for you services.
Project ID: 40437350
6 proposals
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Active 7 days ago
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6 freelancers are bidding on average $66 USD/hour for this job

Hello, my name is Attorney Umar Ghazalli. I provide professional legal support tailored to your specific requirements. You may search “Attorney Umar Ghazalli” online to review my professional background and experience. My areas of specialization include legal research, legal writing, legal drafting, contract and agreement preparation, IP work, and court-related document work. With nearly 20 years of professional experience, I focus on accuracy, clarity, and well-reasoned legal analysis. I would be pleased to discuss your project in detail. Regards.
$75 USD in 40 days
7.9
7.9

With over a decade of extensive experience in diverse legal capacities, including drafting various agreements and engaging with regulatory affairs, I'm confident that I can provide the EU Pharmaceutical Regulatory Affairs Support your company needs. My work as an attorney has equipped me with skills in research, meticulous documentation and a thorough understanding of the EU pharmaceutical regulatory procedures. I have successfully taken on complex Legal Regulatory projects involving different countries and markets similar to the task you've described. For example, I've effectively handled registration processes for medicinal products in multiple European markets ensuring compliance with EU regulatory requirements and guidelines. My knowledge of CTD/eCTD documentation and experience in the full registration process from preparation to submission and coordination of responses will be crucial as I assist you with variations, renewals, lifecycle maintenance, and local regulatory procedures. By selecting me for this role, your company can rest assured knowing that they have a highly organized professional on their team. My excellent communication skills in English guarantee effective and efficient communication with regulatory authorities, clients, and other stakeholders.
$50 USD in 40 days
6.4
6.4

Having over 16 years of experience, I have an impeccable understanding of the legal and documentation aspects crucial for EU Pharmaceutical Regulatory Affairs. With my proficiency in Regulatory Affairs, particularly in the European markets, I am confident in delivering high-quality work within your desired timeframe. My proven track record of successfully registering and maintaining medicinal products across various European countries will be an invaluable asset to your project. I possess a deep knowledge of EU pharmaceutical regulatory procedures and have hands-on experience with CTD/eCTD documentation - ensuring compliance with both local and pan-European standards. Recognizing that effective communication is vital to this task, I assure you of my excellent English-language skills, which extend beyond comprehension to articulate negotiations that yield desired results with regulatory authorities. Moreover, my versatile skill set stretches beyond just regulatory affairs; it encompasses contexts that align beneficially with your project’s goals. For instance, I am well-versed in translation services, and this offers an added advantage when dealing with multiple languages across European markets. I promise not just to meet but to exceed your expectations throughout the entire registration process—ensuring your medicinal products are given top priority for marketing authorization in the European Union.
$50 USD in 40 days
6.2
6.2

Hello, I reviewed your project and it aligns well with my experience in pharmaceutical regulatory documentation and compliance-support workflows. I have previously assisted with medicinal-product registration support, CTD/eCTD document organization, regulatory-response preparation, lifecycle-maintenance coordination, and compliance documentation aligned with European regulatory frameworks. I understand you are seeking an experienced Regulatory Affairs Specialist to support medicinal-product registrations across European markets, including dossier preparation, authority communication, submission management, variations, renewals, and ongoing regulatory maintenance. I can help coordinate regulatory documentation, review submission packages, organize authority-response workflows, and support compliance activities aligned with EU pharmaceutical regulations and procedural requirements. My approach focuses on regulatory accuracy, organized submission management, efficient documentation coordination, and timely communication throughout the registration lifecycle. I am familiar with CTD/eCTD structures, variation and renewal workflows, and multi-market coordination processes involving European regulatory pathways and authority interactions.
$50 USD in 40 days
4.1
4.1

Hello, we’re seeking EU Pharmaceutical Regulatory Affairs Support, and I’d be glad to assist your team end-to-end with medicinal product registrations across Europe. I have proven experience supporting dossier preparation and review under EU requirements, including CTD/eCTD documentation and compliant submission practices. I can coordinate responses to authority questions, maintain clear communication with regulators, and support variations, renewals, and ongoing lifecycle maintenance to keep your submissions on track. I’m comfortable working independently, performing legal/regulatory research, and ensuring documentation aligns with current EU guidelines and submission expectations. To tailor the approach, which countries/markets are highest priority for your registration (e.g., DE, FR, NL, ES, Nordics, UK/EU5), and are you targeting centralized or national/MRP/DCP pathways? Also, what stage is the product currently in, gap assessment, dossier compilation, or pre-submission review?
$50 USD in 17 days
0.0
0.0

Baku, Azerbaijan
Member since May 12, 2026
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