Hartmann Young’s Post

How to get a regulatory affairs job? You should know the 3 basic things mentioned in the video. #job #career #pharmaceuticalindustry

#hiring Regional Regulatory Affairs Officer, Vifor Singapore, Singapore, fulltime #opentowork #jobs #jobseekers #careers #GovernmentDefence Apply: https://lnkd.in/gfAXQxMh Main AccountabilitiesRepresent Regulatory Affairs on various cross-functional teamsContribute to the development of project plans and other deliverablesDocument ControlCreate and revise procedures as neededReview and approve change orders and evaluate for submission requirementsInternal Audits coordination and supportKey Measures of SuccessAligned and compliant regulatory preparations and on time submission on assigned productsEffective monitoring and follow up on products submission progressProper and in time documentation and filing of regulatory records and data with efficient access to relevant stakeholdersClose collaboration with distributors to ensure up to date knowledge sharing and distributors' capabilities in regulation activitiesTasksPerform the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirementsCompile all dossiers required in submissions, license renewal and GMP clearance renewalMonitor and maintain database of registration and status - ensure proper filing and records of regulatory documentation are keptKeep abreast of regulatory procedures and changesRecommend strategies for earliest possible approvals of applicationsEffective communication between global, HQ RA to ensure implementation of all strategic plansLead and drive RA activities in accordance with local requirements to ensure the Company's products are registered on time or life cycle management in the markets are in scope of responsibility, and post marketing surveillance risks are minimizedResponsible for Regulatory monitoring and analysis of new or updated local legislation and for ensuring in-time registration in the relevant countriesCreate a regulatory plan and a labelling plan

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Want to find out more about the role of Regulatory Affairs Specialist? Take a look at this article where we explore the key responsibilities in this role, the benefits of this career path, and share insights into how the role is evolving: https://phrmwb.com/3WLxYfF #regulatoryaffairs #regaffairs #regaffairsjobs #lifesciencejobs #jobfocus

#hiring Regional Regulatory Affairs Officer, Vifor Singapore, Singapore, fulltime #opentowork #jobs #jobseekers #careers #GovernmentDefence Apply: https://lnkd.in/gfAXQxMh Main AccountabilitiesRepresent Regulatory Affairs on various cross-functional teamsContribute to the development of project plans and other deliverablesDocument ControlCreate and revise procedures as neededReview and approve change orders and evaluate for submission requirementsInternal Audits coordination and supportKey Measures of SuccessAligned and compliant regulatory preparations and on time submission on assigned productsEffective monitoring and follow up on products submission progressProper and in time documentation and filing of regulatory records and data with efficient access to relevant stakeholdersClose collaboration with distributors to ensure up to date knowledge sharing and distributors' capabilities in regulation activitiesTasksPerform the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirementsCompile all dossiers required in submissions, license renewal and GMP clearance renewalMonitor and maintain database of registration and status - ensure proper filing and records of regulatory documentation are keptKeep abreast of regulatory procedures and changesRecommend strategies for earliest possible approvals of applicationsEffective communication between global, HQ RA to ensure implementation of all strategic plansLead and drive RA activities in accordance with local requirements to ensure the Company's products are registered on time or life cycle management in the markets are in scope of responsibility, and post marketing surveillance risks are minimizedResponsible for Regulatory monitoring and analysis of new or updated local legislation and for ensuring in-time registration in the relevant countriesCreate a regulatory plan and a labelling plan

#hiring Regional Regulatory Affairs Officer, Vifor Singapore, Singapore, fulltime #opentowork #jobs #jobseekers #careers #GovernmentDefence Apply: https://lnkd.in/gfAXQxMh Main AccountabilitiesRepresent Regulatory Affairs on various cross-functional teamsContribute to the development of project plans and other deliverablesDocument ControlCreate and revise procedures as neededReview and approve change orders and evaluate for submission requirementsInternal Audits coordination and supportKey Measures of SuccessAligned and compliant regulatory preparations and on time submission on assigned productsEffective monitoring and follow up on products submission progressProper and in time documentation and filing of regulatory records and data with efficient access to relevant stakeholdersClose collaboration with distributors to ensure up to date knowledge sharing and distributors' capabilities in regulation activitiesTasksPerform the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirementsCompile all dossiers required in submissions, license renewal and GMP clearance renewalMonitor and maintain database of registration and status - ensure proper filing and records of regulatory documentation are keptKeep abreast of regulatory procedures and changesRecommend strategies for earliest possible approvals of applicationsEffective communication between global, HQ RA to ensure implementation of all strategic plansLead and drive RA activities in accordance with local requirements to ensure the Company's products are registered on time or life cycle management in the markets are in scope of responsibility, and post marketing surveillance risks are minimizedResponsible for Regulatory monitoring and analysis of new or updated local legislation and for ensuring in-time registration in the relevant countriesCreate a regulatory plan and a labelling plan

📝🌐 The Vital Role of Regulatory Affairs in Life Sciences 🌐📝 Following my post on the "Vital Role of Quality Assurance" last week, I want to emphasize that I haven't forgotten about all of you in my Regulatory Affairs network! I can't stress enough how vital Regulatory Affairs professionals are to the success of companies and to the health and well-being of patients worldwide. 🌍💊 Regulatory Affairs experts are the anchor that ensures seamless compliance with the complex web of regulations governing pharmaceuticals, biotechnology, and medical devices. Here's why they're indispensable: Their contributions are: ✅ Patient Safety: Regulatory Affairs ensures that products are rigorously tested and meet stringent safety standards, safeguarding patient health. ✅ Innovation: They pave the way for groundbreaking discoveries by helping companies navigate regulatory hurdles, speeding up approvals, and fostering a culture of innovation. ✅ Market Access: Regulatory experts open global markets, facilitating the availability of life-saving treatments to a broader population. What are your thoughts on Regulatory Affairs? #RegulatoryAffairs #LifeSciences #Innovation #PatientSafety #Healthcare #Compliance #HealthcareRegulations

🌐 Exploring the World of Regulatory Affairs 🌐 Regulatory Affairs professionals are the unsung heroes of the healthcare and life sciences industry, ensuring that products meet the highest standards for safety and efficacy. Here are some fascinating facts about this dynamic field: 1️⃣ Global Impact: Regulatory Affairs is a truly international discipline. Professionals work across borders to navigate a complex web of regulations, ensuring that products can be distributed worldwide. 2️⃣ Diverse Industries: It's not just pharmaceuticals and medical devices! Regulatory Affairs experts play a pivotal role in industries ranging from cosmetics and food to technology and beyond. 3️⃣ Ever-Changing Landscape: Regulations are constantly evolving. Staying up-to-date with the latest changes is a challenging, yet essential aspect of this field. 4️⃣ Patient Safety: Above all, Regulatory Affairs focuses on ensuring the safety and well-being of patients and consumers. It's about making sure the products we use are as safe as they can be. 5️⃣ Interdisciplinary Skills: Regulatory Affairs professionals possess a diverse skill set, from scientific and legal knowledge to excellent communication and project management skills. 6️⃣ Innovation Enabler: Far from being a roadblock, Regulatory Affairs can actually foster innovation by providing a clear path to market for groundbreaking products. 7️⃣ Ethical Core: Ethics and integrity are at the heart of this profession. Regulatory Affairs experts are guardians of public trust and safety. 8️⃣ Global Collaboration: They collaborate closely with government agencies, industry stakeholders, and other experts to ensure compliance and best practices. 9️⃣ Career Opportunities: Regulatory Affairs offers a broad spectrum of career opportunities, from entry-level roles to executive leadership, making it a field with excellent growth potential. 10️⃣ Never a Dull Day: The constant evolution and challenges of this field make every day a new and exciting adventure. Regulatory Affairs professionals are the silent architects of a safer, more regulated world. Their dedication is often unseen but is vital for public health and safety. Let's take a moment to appreciate their hard work and commitment to making our lives better! 👏🌍💼 #RegulatoryAffairs #Healthcare #LifeSciences #Compliance #Innovation #PatientSafety #GlobalImpact #CareerOpportunities

Who ensures the safety and efficacy of the medical products we rely on daily? Dive into the basics of the regulatory affairs domain in healthcare with this insightful video! Discover who works in this critical field and what it encompasses. Ideal for those looking to explore the intricate details of how our healthcare system operates.

Dear All, 🚀 Ready to dive into regulatory affairs? It's a path filled with rewarding challenges and opportunities. Here's a breakdown of this field: 🔍 Understanding Regulatory Affairs: In life sciences, regulatory affairs ensures the safe development of healthcare products. Think pharmaceuticals and medical devices. 🤓 Role of a Regulatory Affairs Pro: They keep up with evolving laws, offer compliance guidance, and organize vital data. They prepare registration docs and handle market authorizations, even approving packaging and ads. 💥 In-Demand Career: Industries like pharmaceuticals and medical devices are always on the lookout for skilled regulatory professionals. Exciting opportunities await! 🌟 Your Path in Regulatory Affairs: Whether you're dreaming of entering this field or are a seasoned pro seeking new challenges, let's chat! Share your thoughts or questions below. #RegulatoryAffairs #RAjob #howtogetaRAjob #CareerAdvice #LifeSciences 📊🏥💼