#NMDPharma is #hiring! We’re looking for a Senior Associate of Regulatory Affairs preferably based in Denmark (Aarhus or Copenhagen), the USA (East Coast) or remotely based in Europe. If you have experience in regulatory affairs management, and global regulatory health authorities, we’d love to hear from you. As a growing #biotech with three ongoing Phase 2 trials underway we are looking to expand our team with a Senior Associate of Regulatory Affairs. Key responsibilities include coordinating the content and drafting of regulatory documentation, assisting in the development of regulatory strategy, and preparing routine submissions and related activities. Find out more about this position and apply online through the link below: https://lnkd.in/d58AhiXv #NeruomuscularDisease #Innovation #Biotech #Research #Jobs #Recruitment #RareDisease
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🚀 Awesome position alert 🚀 Oxford Nanopore Technologies is hiring a Senior Director of Regulatory Affairs, and I can't help but feel a little envious—wishing I had regulatory experience commensurate to this role: https://lnkd.in/gwPj53fD The upcoming launch of the Q-Line sequencing portfolio (kicking off with the GridION™ Q in 2025) represents the cusp of real-time, on-demand nanopore sequencing in a clinical-grade format, and it's poised to be the backbone for routine, long-term workflows in clinical and applied settings by mid-2025. 🌐 I see tremendous potential in the third generation of genome-sequencing technologies - in particular when built on a foundation that's ISO 9001:2015 compliant and adheres to 21 CFR Part 11 & EU GMP Annex 11 standards. OK, but *why* is this so exciting? It's not just the ability to bring epigenomics and epitranscriptomics into clinical practice, or to revolutionize pharmacogenomics ... Rather, as just one example, I'll offer this: there are good reasons to suspect that adaptive sequencing can streamline (clinical) genome-slicing protocols in ways that NGS-based assays cannot ... Finally, if none of that is exciting enough, the rapid evolution of the US and European regulatory landscapes promises a stimulating environment for those capable of navigating the intersection of technological innovation and regulatory frameworks. Can't wait to see who #ONT chooses for this role to maximize clinical impact! #Genomics #CareerOpportunity #RegulatoryAffairs #QLine #ISO9001 #ClinicalSequencing
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Biopharma Regulatory Affairs: A World of Opportunities! Embarking on a career in Biopharma Regulatory Affairs is both challenging and rewarding. Here’s a brief guide to navigating this path, 1. Scientific Knowledge: It’s our foundation. Understand the science behind what we regulate. It’s like having a map in an unfamiliar place. 2. Clear Communication: Break down complex regulations into clear, actionable advice. It’s about making the complex simple. 3. Stay Updated: The biopharma world is ever-evolving. Continuous learning through certifications and workshops is crucial. Think of it as constantly updating your software to the latest version. 4. Network: Every person you meet is a potential treasure trove of knowledge. Attend industry events, engage in forums, and never underestimate the power of a coffee chat. 5. Persistence: Challenges are inevitable. Each one is a stepping stone towards growth. Keep climbing, the view from the top is worth it. In a nutshell, build a strong base, communicate clearly, keep learning, network, and stay persistent. Together, we can make a difference. #Hrushikeshbelappurkar #Biopharma #RegulatoryAffairs
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Opportunity
Join us as a Technical Lead for Drug Development & Regulatory Processes! Lead market-shaping initiatives, work closely with CHAI, and drive impactful change in healthcare. Apply now: Vacancy24@wrhi.ac.za #JobOpening #TechnicalLead
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🔷 People overcomplicate looking for an entry level regulatory affairs role🔷 Listen, if you are trying to break into regulatory affairs Avoid: • Sending your general CV out • Not applying for enough roles • Not understanding what you are applying to • Applying for regulatory roles that require experience • Obtaining a qualification that doesn't enhance your career prospects • Gaining experience not relevant to regulatory affairs or the pharmaceutical industry Instead: • Sign up to a regulatory affairs introductory course • Obtain regulatory affairs work experience • Tailor your CV towards regulatory affairs • Start applying to many roles Focus on this for two months You will see the difference. 🔷 Get FREE regulatory resources and find out how you can get an entry level job in regulatory affairs🔷 https://lnkd.in/eiS5ft3m 🎁 To get £200 off the Introduction to Regulatory Affairs Course: • Like • Comment 'regulatory' • Connect with me Registration for the November cohort will end this Saturday,16th November #regulatoryaffairs #regulatorytrainingcourses #regulatorycourses #regulatoryworkexperience #entrylevelregulatoryaffairsjobs #regulatoryaffairscertification #regulatoryaffairstraining #Howtogetajobinregulatoryaffairs
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A young student in my LinkedIn circle recently asked me what are key behaviours or skill set that can help to make a successful career in Regulatory affairs. Sharing my response below - Advancing in Drug Regulatory Affairs requires a comprehensive skill set. Key skills include a deep understanding of regulatory guidelines and global regulations, strong communication and negotiation abilities, and meticulous attention to detail. Project management skills are essential for coordinating submissions and managing timelines. The ability to interpret and analyze scientific data is crucial, along with critical thinking and problem-solving skills. Familiarity with regulatory submission processes and proficiency with relevant software tools are also important. Staying updated with industry trends and continuing education in regulatory policies will further enhance your expertise. #regulatoryaffairs #careeradvancement
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Our commitment for top quality and maximal safety is deeply rooted in the work of our dedicated Regulatory Affairs Department. It’s time we take an inside look into the whole process. The department is first and foremost a full partner to all the processes we conduct, including management of our regulatory strategy, involvement in improvement projects and risk management. Expertly led by Nelly Sebban-Schwob the department deals with submission of applications - for both new and existing medicinal products. The projects are divided between two teams headed by Yana Aisen and Tamir Kanush and for each submission or change, a variety of factors is examined before a decision is made in collaboration with other departments. The leading principle for medicine assessment is a matter of risk vs benefit. This assessment is based on quality, safety, efficacy and risk management. The medicinal product dossier consists of 5 modules. Module 1 is the administrative module, including the leaflet for the medicinal product. Module 3 is CMC (Manufacturing and controls). The preclinical studies are the 4th module, and the 5th one includes the clinical studies. Module 2 is a summary of all the other modules. There is a huge responsibility here, as well as a great sense of purpose. In fact, now you can take part in this meaningful work as a Senior Regulatory Affairs Specialist. You can submit your CV right here >> https://lnkd.in/djDfqPcC Nelly Sebban-Schwob Tamir Kanush Yana Aisen #development #growthmindset #inspiring #teamworksuccess
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🎙️Meet Hrabrina Hristova, Global Head of Regulatory & Safety Services at #ComacMedical. In this exclusive interview, Hrabrina shares a glimpse into her dynamic role, from leading regulatory projects to collaborating with cross-functional teams such as project management and business development to ensure alignment with company goals. She also offers her expert advice for anyone aspiring to start a career in Regulatory Affairs & Pharmacovigilance. If you have a keen eye for detail and a passion for safeguarding global health, this might just be the career path for you! 🌟 Watch Now 👉 Discover key insights from a leading expert in the clinical trial industry. #CareerGrowth #RegulatoryAffairs #Pharmacovigilance #HealthcareCareers #ComacMedical
Expert Spotlight: Hrabrina Hristova - Global Head of Regulatory and Safety Services
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Thrilled to share I have earned my clinical research, clinical data management, Regulatory affairs, Pharmacovigilance .this program heared me to develop my skills in Pharmacovigilance, clinical research, clinical data management, Regulatory affairs domains and i am excited to appling my new knowledge in healthcare industry and gain more knowledge and experience. thankful to my instructor to guidence my skill are include #CRFDESGIN #Protcolguidline #Querymanagement #SAERECOSULATION #Labrecosulation
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🔍 Top Skills Every Regulatory Affairs Pharmacist Should Master 💼 In the dynamic world of pharmaceuticals, the role of a Regulatory Affairs Pharmacist is crucial to ensuring that products comply with all regulatory requirements. Here are the most important skills that set successful professionals apart in this field: Attention to Detail 🧐 Regulatory documentation requires meticulous accuracy. The ability to spot even the smallest errors can make a big difference in compliance and approval processes. Analytical Thinking 🧠 Evaluating scientific data and interpreting complex regulations necessitates strong analytical skills. A clear understanding of guidelines and the ability to apply them practically is essential. Communication Skills 🗣️ Effective communication, both written and verbal, is key. Regulatory pharmacists must liaise with regulatory bodies, cross-functional teams, and stakeholders, conveying information clearly and concisely. Project Management 📊 Managing multiple projects and deadlines requires exceptional organizational skills. Being able to prioritize tasks and coordinate with different departments is critical for timely submissions. Regulatory Knowledge 📚 A thorough understanding of local, regional, and international regulations is fundamental. Keeping abreast of changing regulations and industry standards ensures compliance and competitive advantage. Problem-Solving 🛠️ Navigating regulatory challenges and finding compliant solutions demands creative and strategic problem-solving abilities. Ethical Judgement ⚖️ Upholding the highest standards of ethics and integrity is paramount in regulatory affairs. Ensuring that all practices meet legal and moral standards protects public health and the company’s reputation. Technological Proficiency 💻 Familiarity with regulatory software and digital tools is increasingly important. Proficiency in these technologies enhances efficiency and accuracy in regulatory submissions. Collaboration 🤝 Working closely with R&D, marketing, quality assurance, and other departments requires strong interpersonal skills. Building good relationships facilitates smoother processes and better outcomes. Continuous Learning 📖 The regulatory landscape is ever-evolving. A commitment to continuous learning and professional development ensures that skills and knowledge remain current and relevant. Mastering these skills not only enhances your effectiveness as a Regulatory Affairs Pharmacist but also significantly contributes to the success and compliance of your organization. What skills do you think are essential for a career in regulatory affairs? Share your thoughts and experiences in the comments! #RegulatoryAffairs #Pharmacy #PharmaceuticalIndustry #CareerSkills #ProfessionalDevelopment #Pharmacist
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Toxicologist and Animal Welfare Officer
1moA great opportunity to come and join me and my other excellent colleagues at NMD Pharma 🤩