Link Talent’s Post

🔍 Unlock Your Career Potential in Regulatory Affairs! 🔍 🌟 Regulatory Affairs of Drugs and Medical Devices Training Program (USA & Europe) 🌟 Are you ready to advance your career in the pharmaceutical and medical device industries? Join our comprehensive training program designed to equip you with the essential skills and knowledge to navigate the complex regulatory landscapes of the USA and Europe. 📅 Program Highlights: In-depth understanding of regulatory processes for drugs and medical devices. Insight into Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Quality Assurance (QA), and Quality Control (QC). Expert-led sessions by industry professionals with extensive regulatory experience. Case studies and real-world scenarios to enhance practical understanding. Networking opportunities with peers and industry leaders. 🌐 Why Choose Our Program? Expert Instructors: Learn from seasoned professionals who have successfully navigated regulatory environments. Comprehensive Curriculum: Covering all critical aspects of regulatory affairs, ensuring you are well-prepared for any challenge. Flexible Learning: Online modules that fit into your schedule, allowing you to learn at your own pace. International Focus: Gain insights into both USA and European regulations, making you a versatile candidate for global opportunities. 📈 Who Should Enroll? Aspiring regulatory affairs professionals Current industry professionals looking to update their knowledge Compliance officers and quality assurance personnel Medical and healthcare professionals aiming to transition into regulatory roles 💼 Career Benefits: Enhance your qualifications and stand out in the competitive job market. Increase your earning potential with specialized knowledge in regulatory affairs. Expand your professional network and open doors to new career opportunities. 🔗 Join Now! Don’t miss out on this opportunity to advance your career in the regulatory affairs of drugs and medical devices. Enroll today and take the first step towards becoming an industry expert with the 4th of July 20% off! 👉 Apply Here: https://lnkd.in/dRyfprsb 📞 Contact Us: For more information, reach out to our admissions team at Whatsapp +1 (954) 488-4372 email info@radexeducation.org Stay ahead in your career with our Regulatory Affairs of Drugs and Medical Devices Training Program (USA & Europe). Your path to success starts here! hashtag #RegulatoryAffairs hashtag #Pharmaceuticals hashtag #MedicalDevices hashtag #CareerDevelopment hashtag #TrainingProgram hashtag #USA hashtag #Europe hashtag #QualityAssurance hashtag #GoodManufacturingPractice hashtag #GoodClinicalPractice hashtag #ProfessionalDevelopment hashtag #OnlineLearning

Al Andalous Medical Company, 6th of october city, Egypt " Export Regulatory Affairs Specialist". - job Description: - Facilitate the company's entry into new and diverse markets by overseeing the registration process. - Develop and implement the regulatory procedures required for entering various export markets, both new and established, and ensure compliance with registration. - Compile and prepare Export Registration documentation for different countries, as well as re-registration dossiers for products. - Establish and uphold a strong registration track record in export markets, consistently meeting the necessary requirements for successful registrations. - Respond promptly to any necessary product modifications, such as changes in packaging, formula, or name, in order to streamline the registration process across different countries. - Cultivate and maintain positive relationships with both internal and external stakeholders. - Monitor and manage all stages of export registration, working closely with agents and the Ministry of Health in different countries. This includes conducting Stability Studies, Bioequivalence Studies, preparing inserts and packs, performing analyses, and pricing determination. -Ensure that all registration activities conducted by Al Andalous Pharmaceutical Company are in full compliance with both company policies and relevant national laws and regulations. -Maintain a strict level of confidentiality regarding the content of registration files. -Thoroughly review compiled registration files to verify their compliance with the applicable regulations of each market, paying close attention to content, quality, accuracy, and format. - Collaborate with members of the R&D, Quality Control, Production, and Marketing teams to address various registration-related matters. *Requirements: - Minimum two years experience as Export Regulatory Specialist in Well established Pharmaceutical company with successful record in export business. Interested candidate can send his/her C.V on: Career@alandalous.org Kindly mention the job title in the Subject, #manufacturing #vacancy #pharmaceutical #recruiting #jobvacancy #jobalert #vacancy #qualitycontrol #qualitycontrolanalyst #qualityanalyst #Otsukapharmaceutical #Obourcity #QC #QCanalyst #regulatoryaffairs #pharmaceuticalindustry #pharmaceutical #CTD #cmc #Regulatory #Pharma #pharmacy #science #Hiring #vacancy #pharmaceuticals #pharmacist #pharmaceuticalmanufacturing #hospital_pharmacist #hospitals #qualitycontrol #quality_control #veterinarymedicine #qualitysystems #qualityassurance #quality_control_professional #egypt #sciencejobs #sciencejobs #pharmaceutical #pharmaceuticalindustry #pharmaceuticalmanufacturing #pharma #pharmacy #pharmacists #sciencejobs #biochemistry #agriculture #agriculturelife #fresherjobs #freshers2024 #freshers2023 up, mention and share please follow to see more jobs #antonious_fares

Another day filled with excitement, learning, experience sharing, and networking. A new day brings new achievements and success. Visit us! #sopconsultancycenter #pharmacovigilance #training #trainingcourse #regulatoryaffairs #qualityassurance #quality #GCC #pharmaGCC #GCCPharmaSummit #dubai #auditing #consultation

#REGULATORYAFFAIRS hashtag#CRA hashtag#DataENTRY. hashtag#Freelance with full competence in: A) Regulatory affairs: -compilation of dossiers for marketing authorisation applications/application for or renewal of CE marking (french authorities) B) Clinical research hashtag#All specialities: -Drafting of documents: protocol, Crf , Information letter, study documents, Financial agreement... - Site selection, Implementation, Monitoring, Closure, Pharmacovigilance/ Matériovigilance.... C) From Data Entry hashtag#All specialities: -Help with inclusions, -Completion of crf, -Pharmacovigilance/ Materialovigilance... My commitments: -Quality in accordance with GCP/ICH & MDR 2017/745. -Respect for deadlines & experience of large sectors (time is money). - I can travel anywhere and/or remotely. -Competitive rates. See you soon

Are you steering your career through the complex web of Quality Assurance (QA) in pharma? It's more than just dots and crosses on technical sheets - it's about mastering the evolving regulatory maze🌐. Here's the kicker; with Ireland's rise as a pharma hub, the doors to opportunity are wide-flung open for QA pros.🍀 - 📜 EMA Guidelines: Know your European Medicines Agency inside out - stay on top of changes. - 🇬🇧 MHRA Rules: The Medicines and Healthcare products Regulatory Agency keeps Britain's standards tip-top - get clued in. - 🧪 ICH Q8 to Q12: The International Council for Harmonisation - it's all about quality, from pharmaceutical development to lifecycle management. - 👥 GxP Practices: Good anything Practices - Clinical, Manufacturing, Laboratory, Documentation - make these your daily mantras. - 🚀 ISO Standards: The global language of quality - keep your ISO knowledge as sharp as a needle. Embarking on this journey or elevating your QA career in the pharma sector demands more than a keen eye for detail - it's about grasping the essence of regulations that shape our industry. What if you had a recruitment partner who could translate the jargon into actionable insights?💡 Let's join forces to chart a crystal-clear course for your career in QA. #QualityAssurance #PharmaCareers #RegulatoryExpertise

**Title: Introduction to Regulatory Affairs: Roles, Responsibilities, and Career Pathways** Are you curious about the field of regulatory affairs? 🤔 Let's delve into the fundamentals together! **Introduction:**👇 Regulatory affairs play a crucial role in ensuring the safety, efficacy, and quality of pharmaceuticals, medical devices, biologics, and other healthcare products. From navigating complex regulations to facilitating product approvals, regulatory affairs professionals are at the forefront of ensuring compliance with regulatory requirements. **Roles and Responsibilities:**🌐 In regulatory affairs, professionals are responsible for a wide range of tasks, including: - Interpreting and implementing regulatory requirements - Preparing and submitting regulatory submissions to health authorities - Conducting regulatory intelligence to stay updated on changes in regulations - Collaborating with cross-functional teams to ensure regulatory compliance throughout the product lifecycle - Representing the company in interactions with regulatory agencies - Participating in regulatory inspections and audits **Career Pathways:**🚀 The field of regulatory affairs offers diverse career pathways, including: 1. Regulatory Affairs Officer /Specialist: Entry-level role focusing on assisting with regulatory submissions and compliance activities. 2. Regulatory Affairs Associate/Manager: Mid-level role responsible for managing regulatory projects, submissions, and interactions with regulatory agencies. 3. Regulatory Affairs Director/Manager: Senior-level role overseeing the regulatory strategy and compliance efforts for a company or product portfolio. 4. Regulatory Consultant: Independent consultant providing expertise and guidance on regulatory matters to companies in the healthcare industry. 5. Regulatory Affairs Trainer/Educator: Role focused on training and educating professionals on regulatory requirements and best practices. **Conclusion:**💐 As you can see, regulatory affairs is a dynamic and essential field within the healthcare industry. Whether you're just starting your career or looking to advance, there are numerous opportunities to make a meaningful impact in ensuring the safety and efficacy of healthcare products. Stay tuned for more insights into this exciting field! #RegulatoryAffairs #healthcarecareer #RegulatoryAffairs #Compliance #QualityAssurance #MedicalDevices #Pharmaceuticals #FDARegulations #HealthcareCompliance #RegulatoryCompliance #LifeSciences #GMP #ClinicalTrials #RegulatoryUpdates #DrugApproval #Biotechnology # #drap #nafdac #tga #ema #cdsco #sfda #sahpra #era #FDA #EMA #EMAnews #MHRA #TGA #CFDA #EMAupdates #FDAupdates #RegulatoryAgency #RegulatoryAuthorities #HealthCanada #HealthAuthority #EMAcompliance #FDAcompliance #RegulatoryStandards #RegulatoryGuidance #who #pics #drap #sfda #mhra #tga #nafdac #cdsco

Course Link : https://lnkd.in/dU3KWSA2 This Course is best suitable for Quality control, quality assurance and production department employees, who wants to enhance their knowledge & migrate to Regulatory affairs department. - It is best suitable for M.Pharmacy, B.Pharmacy & M.Sc. freshers who wants to pursue their career into Regulatory affairs department. Course duration: 30 days Timings: Evening 8 pm to 9 pm Mode of teaching: Online Medium of teaching: Through SG PHARMA TRAININGS application (It was like Zoom) Trainer: Varsha Kakkar -worked in both API and Formulation organizations -17+ years' experience in Regulatory affairs - worked in Industries like Dr. Reddy's, Cipla, Pfizer...etc. Syllabus: Drug regulatory affairs program. • Overview of all the dept in industry and their role in RA • Regulatory requirements for US, EU and ROW markets (in detail) • Types of submissions DMF / CEP etc.…. (In detail) • Annual Updates • health authorities • Indian submissions • ICH guidelines/ cGmp • Preparation of query responses • Preparation for interview • Study Material • Communication Skills Training Training in detail • Overview of all the dept in industry and their role in RA • Q.A • Q.C • R.A • Analytical • R&D • Production • Warehouse • Microbiology • Regulatory requirements for US, EU and ROW markets (in detail) • US submission • What is USFDA how it works? • Types of DMF (Drug master file) in detail • What is CTD format in detail • How to write DMF • How to represent • Annual updates • Deficiency responses • Queries USFDA • US inspections • EIR (Establishment of inspection report) • FDA 483 • Recall product • EU submissions • EMA (European medicine agency) • Types of submissions • Centralized • Decentralized • MRP (mutual recognition procedure) • How to write ASMF (Active substance master file) • How to represent • What is COS (certificate of suitability) • When can a product go for COS filing • How to submit COS to EDQM (European directorate for quality of medicines) • Its validity • Renewal of COS • Deficiency responses • Inspection • Health authorities • Discussion • Types of Health authorities • Their role in drug registration • How they differ • CTD format • Types of Modules • Module 1(M1) Administrative information • Module 2(M2) Quality overall summary • Module 3(M3) Manufacturers section (Drug product and Drug substance) • Module 4(M4) Nonclinical data • Module 5(M5) clinical data • eCTD • How to prepare Dossier /DMF in eCTD format • Indian submissions • The Drug Controller General of India • (DCGI) • Functions of DCGI • CDSCO (central drug standard control organization) • Functions of CDSCO • Regulatory Authorities in India; Roles & Responsibilities • Indian submission procedure • Overview of guidelines • Overview of validations (Process, Analytical) • What is validation • Types of validation • Analytical validation

🌟 A Day in the Life of a Regulatory Compliance Specialist 📜💻 👩💼 Meet Laura, a detail-oriented Regulatory Compliance Specialist in the pharmaceutical industry, ensuring adherence to regulatory requirements and maintaining product compliance 🌟 💻 Laura's day starts by reviewing and updating regulatory guidelines, monitoring changes in regulations, and communicating updates to internal stakeholders 📚🔍 😰 The challenge lies in navigating complex regulations, managing multiple projects simultaneously, and proactively identifying potential compliance issues 🌐🔒 🤝 Laura collaborates with cross-functional teams, including quality assurance, legal departments, and regulatory agencies, to ensure product compliance and address any non-compliance situations 📢🤝 💡 Together, they develop and implement compliance strategies, conduct internal audits, and create SOPs to maintain adherence to regulations throughout the entire product lifecycle 🗂️🔒 ✨ When Laura successfully guides a product through regulatory inspections and receives positive feedback from regulatory authorities, she feels a sense of accomplishment, knowing her work plays a crucial role in patient safety 👨⚕️✔️ 🌟 At the end of each day, Laura reflects on the importance of regulatory compliance in upholding the highest standards of quality, safety, and ethics in the pharmaceutical industry 🌟 #RegulatoryComplianceSpecialist #PharmaceuticalRegulations #ProductCompliance #PatientSafety ------------------- 🌟 A Day in the Life of a Pharmaceutical Manufacturing Technician 👩🔬🧪

🔷️How to Get an Entry Level Role in Regulatory Affairs?🔷️ Are you looking for a job in regulatory affairs? Let's discuss the steps you can take to help you get into regulatory affairs. • Research about what regulatory affairs is. The different areas. What regulatory affairs officers do. The skills and experience needed. • Think about what areas of regulatory affairs you find interesting. What you enjoy about the role. The transferrable skills and experience you have. • Tailor your CV towards a position in regulatory affairs focusing on the skills and experience that are important. • IMPORTANT: If you see any gaps between your CV and a role in regulatory affairs then fill these gaps by; • Taking up courses in regulatory affairs. We offer a 30 CPD hour introductory course in regulatory affairs (covering EU, UK and US regulations) • Applying for work experience / internships in regulatory affairs. We offer up to two months work experience for students of our introductory course. • You can also speak to regulatory affairs professionals to learn more about what they do and expand your network • Be open. Initially you may not get a role in regulatory affairs, or an area of regulatory affairs that you are interested in but take opportunities that will help you see how it is like working in the pharmaceutical industry or bring you closer to your desired position. As an entry level candidate be open to any experience in the pharmaceutical industry. • Apply for many different types of roles, in different types of companies. Entry level regulatory roles can be called: regulatory affairs administrator, submission coordinator, regulatory affairs associate, regulatory affairs officer, regulatory affairs executive or regulatory affairs advisor. Apply to both large pharma, smaller companies and consultancies. • Don't give up. • Follow me to get more advice on starting a career in regulatory affairs. 🔷️Introduction to Regulatory Affairs Course🔷️ If you are interested in becoming a regulatory affairs professional but have no experience, or if you have experience but would like to have a strong foundation in the basics of regulatory affairs, then this course is for you. This course provides you with: • A strong foundation in EU, UK and US regulatory affairs, regulatory medical writing and medical devices • Work experience assignments (4 weeks) • Work experience project (1 month, part time) • Real world case studies • Job search support • 30 CPD hours of lectures • Expert CV review and interview preparation • Exclusive supportive professional community • Certificate 🔷️Learn more and get free access to the first two lectures, sample case study and work assignment at:🔷️ https://lnkd.in/eiS5ft3m Next Cohort Date: 7th September 2024 (part time over a month) On-Demand Recordings with Live Support Limited Spaces. 15 spaces

🌟 A Day in the Life of a Regulatory Compliance Specialist 📜💻 👩💼 Meet Laura, a detail-oriented Regulatory Compliance Specialist in the pharmaceutical industry, ensuring adherence to regulatory requirements and maintaining product compliance 🌟 💻 Laura's day starts by reviewing and updating regulatory guidelines, monitoring changes in regulations, and communicating updates to internal stakeholders 📚🔍 😰 The challenge lies in navigating complex regulations, managing multiple projects simultaneously, and proactively identifying potential compliance issues 🌐🔒 🤝 Laura collaborates with cross-functional teams, including quality assurance, legal departments, and regulatory agencies, to ensure product compliance and address any non-compliance situations 📢🤝 💡 Together, they develop and implement compliance strategies, conduct internal audits, and create SOPs to maintain adherence to regulations throughout the entire product lifecycle 🗂️🔒 ✨ When Laura successfully guides a product through regulatory inspections and receives positive feedback from regulatory authorities, she feels a sense of accomplishment, knowing her work plays a crucial role in patient safety 👨⚕️✔️ 🌟 At the end of each day, Laura reflects on the importance of regulatory compliance in upholding the highest standards of quality, safety, and ethics in the pharmaceutical industry 🌟 #RegulatoryComplianceSpecialist #PharmaceuticalRegulations #ProductCompliance #PatientSafety ------------------- 🌟 A Day in the Life of a Pharmaceutical Manufacturing Technician 👩🔬🧪