Hire the best ProductDossier TouchBase specialists
Check out ProductDossier TouchBase specialists with the skills you need for your next job.
- $55 hourly
- 0.0/5
- (1 job)
I work as a Regulatory Affairs for Pharmaceutical and Medical Device with over 14 years of experience in the Southeast Asia and APAC regions. I am eager to expand my expertise in regulatory submissions with any regulatory agents. My strong project management skills and effective communication abilities enable me to collaborate seamlessly with clients and stakeholders. Key Skills: -Regulatory Affairs Expertise: Proficient in navigating regulatory frameworks and ensuring compliance across various markets, particularly in the pharmaceutical and healthcare sectors. - Language Proficiency: Native Chinese speaker with excellent written and spoken English, allowing for effective communication in diverse environments. - Research and Analysis: Adept at conducting thorough research and providing insights to facilitate informed decision-making in regulatory processes. - Project Management: Proven track record of managing multiple projects simultaneously, ensuring timely delivery and adherence to quality standards. Why Choose Me: I am passionate about helping organizations navigate the complexities of regulatory requirements. My commitment to excellence and attention to detail ensures that all documentation and submissions meet the highest standards. I look forward to contributing my skills to help your projects succeed.
ProductDossier TouchBase
Content WritingAcademic EditingProofreadingData EntryGeneral TranscriptionWritingEnglish to Chinese TranslationChinese to English TranslationDrug RegulationMedical DevicePharmaceutical IndustryPharmaceuticalsRegulatory ComplianceRegulatory Intelligence - $50 hourly
- 0.0/5
- (0 jobs)
More than 2 years experience in the regulatory compliance thought product regulatory life cycle and timely as well as qualitative submission of Dossiers in Global regulatory authority. To ensure compliance of regulatory requirements, in-house quality system and ICH guidelines in analytical development, FND and packaging. Specialities: • To review and compilation Technical data for dossier preparation and submission for various regions like Europe, Latin America, Africa & Asia Pacific etc., • Handling of queries after product filling in different markets. • Compilation of documents & prepare dossier like ACTD, CTD & eCTD as per country requirements and regulatory authority format. • Review of technical documents and manufacturing documents like COPP/PP/FSC/SMF etc. • Managing the development and maintenance of the product information for marketing authorization activity/artwork development/artwork issuance for commercialization in EU market. • Experience and knowledge of software used in regulatory department like eCTD submission software, MS Office, SAP & Artwork and change control software etc.
ProductDossier TouchBase
International BusinessProduct Lifecycle Management SoftwareCompliance ConsultationArtwork & Print SpecsProduct LabelRegulatory IntelligenceDrug RegulationRegulatory Compliance - $10 hourly
- 0.0/5
- (0 jobs)
Pharmacist specialist in regulatory strategist and project submission management for new registrations and lifecycle. I have extensive experience in different functions accros the organizations, working in Regulatory Regional Strategist Hub , Project Submission Management (operations), Local Regulatory and Quality Control ; which gives me a broad view and understanding of End to End regulatory process within large and complex organizations. I thrive challenges and continuous improvement.
ProductDossier TouchBase
Chemical AnalysisRegulatory IntelligenceRegulatory CompliancePharmaceuticalsPharmaceutical Industry - $15 hourly
- 0.0/5
- (2 jobs)
I am Amita Kajrolkar, a dedicated medical and regulatory writer with 5 years of experience creating clear, precise, and impactful content for the healthcare and pharmaceutical sectors. My expertise includes developing clinical trial documents, regulatory submissions, and scientific publications that meet stringent industry standards. With a strong background in medical writing, I ensure your documents are not only compliant but also compelling. Let’s work together to elevate your medical and regulatory writing needs with accuracy and professionalism! 🚀 Services I Offer 🔹 Regulatory writing for clinical trials, protocols, and submission documents 🔹 Medical writing for manuscripts, white papers, and scientific publications 🔹 Clinical study reports, patient narratives, and safety summaries 🔹 Standard Operating Procedures (SOPs) and training materials 🔹 Literature reviews, systematic reviews, and data analysis 🔍 Niche Expertise 🔹 Clinical trial protocols and regulatory submissions 🔹 Manuscript development and scientific publications 🔹 Medical communications and content strategy 🔹 Safety reporting and pharmacovigilance documents 🔹 Health economics and outcomes research (HEOR) 💡 Why Choose Me? ✔️ 5 years of focused experience in medical and regulatory writing ✔️ Knowledge of industry standards, including ICH, EMA, and FDA guidelines ✔️ Commitment to delivering high-quality, compliant, and timely documents ✔️ Strong attention to detail and clarity in complex writing ✔️ Excellent communication and collaborative work approach 📞 Let’s Get Started! Ready to enhance your medical and regulatory documents? Contact me today, and let’s discuss how I can help achieve your project goals!
ProductDossier TouchBase
BrochureProduct LabelTechnical ManualScience FictionPharmaceutical IndustryGhostwritingContent WritingScience & MedicineMedical WritingClinical TrialScientific WritingDrug RegulationPharmaceuticalsMedical Device - $20 hourly
- 0.0/5
- (0 jobs)
Perfil Profesional Ingeniera Electrónica Colegiada y Habilitada con experiencia en Infraestructura Hospitalaria, Mantenimiento de Equipos biomédicos, Telecomunicaciones, y Control de instrumentación. Hábil en liderazgo, trabajo en equipo, toma de decisiones bajo presión y gestión de personal. Profesional responsable, empática y adaptativa, enfocada en la creación de climas laborales agradables y en el cumplimiento de objetivos empresariales.
ProductDossier TouchBase
Excel FormulaSolidWorks - $15 hourly
- 0.0/5
- (0 jobs)
PROFILE An energetic, motivated and highly dynamic PHARMACEUTICAL SALES EXECUTIVE with excellent strategic, sales, marketing and extensive experience developing business and proven success leading strategy to achieve commercial goals and improve profits in the competitive pharmaceutical industry. KEY COMPETENCIES * Quick to identify potential problems, prioritize and respond. * Natural determination, drive, flair and readiness for a challenge. * Confidence, ability to take on challenging roles. * Friendly and confident with a natural ability to engage at all levels. * Calm and assured in busy and pressurized situations. * Creative thinking and providing innovative solutions. * Natural ability and pride in the provision of high standards of service.
ProductDossier TouchBase
Product Catalog Setup & OptimizationProduct AuditProduct DemonstrationProduct DesignProduct DescriptionProduct ConceptProduct Catalog UpdateProduct ArchitectureProduct BacklogProduct AnalyticsLive InterpretationSoftware LocalizationLocal OperationsTranslation - $25 hourly
- 0.0/5
- (0 jobs)
PROFILE Regulatory Affairs and Quality Assurance Specialist with more than 10 years of enterprise manufacturing,regulatory affairs and laboratory quality assurance experience including standard operating procedure planning implementation and execution. ASEAN Technical Dossier preparation and evaluation and Biowaiver are some of my expertise Competitive excellence in the field of microbiology and quality control testing of pharmaceutical and food products. Expose in the field of manufacturing process, internal and FDA inspections.
ProductDossier TouchBase
Regulatory CompliancePharmaceutical Industry - $30 hourly
- 0.0/5
- (0 jobs)
Profile Summary * Research & Development professional with nearly 14 years of rich product development and project management experience who excels at leading cross-functional teams and coordinating multiple projects * Strategic Planning: Proven competency in collaborating with the Senior Management and providing strategic direction on product development roadmap and initiatives in line with the core organizational goals and business & profit objectives of the company * Project Planning & Management: Leading evaluation of project, present cost/benefits analysis at project decision points; finalizing requirements & specifications and resource planning * Skilled in monitoring project status during periodic project review meetings; participating in project meetings for evaluating project progress including ensure adherence to quality and safety norms * Managed key client like UNICEF , IDA, Spiro Australia, Zoaetis, MSD, CEVA France
ProductDossier TouchBase
Product DesignArt & DesignRegulatory IntelligenceRegulatory ComplianceVendor ManagementProduct FormulationAudition Preparation - $50 hourly
- 0.0/5
- (0 jobs)
Career objective Seeking for suitable position in the esteemed organization while merging into a globally focused organization that will purposefully utilize my qualifications to integrate personal enrichment with professional and prestigious organization goals. Professional strengths: * Knowledge of USFDA guidance's, ICH guidance's, Global emerging market guidelines and regulatory requirements globally. * Able to build effective team work by co-ordination, effective communications and get work done from related stake holders for timely submission. * Detailed knowledge of analytical chemistry, manufacturing and controls processes of drug product. * Knowledge and understanding aspects of clinical trials, clinical endpoint study, bioequivalence study and pharmacovigilance. * Possess excellent presentation, critical thinking and communication skills both in verbal
ProductDossier TouchBase
Technical DocumentationPharmaceutical IndustryDrug Regulation - $25 hourly
- 0.0/5
- (0 jobs)
pharmaceutical, bulk drug, GMP,GLP, pollution control, environmental clearance, food, QA,QC, water system, AHU system, operation, vendor development, machine placement, licensing, product development
ProductDossier TouchBase
Financial AuditGood Manufacturing PracticeQA TestingLicensingWaterChemistryInternal AuditingChemicalsPharmaceutical IndustryFoodAPITestingFood PatternMachine Design - $11 hourly
- 0.0/5
- (0 jobs)
Preparation of Dossier CTD, ACTD & Country specific dossier. Module 1: Administrative and prescribing information (specific to the region where the submission is made, e.g., ROW & ASEAN). Module 2: Summary of quality, non-clinical, and clinical data. Module 3: Quality (Chemistry, Manufacturing, and Controls - CMC) information. Module 4: Non-clinical study reports (Pharmacology, Toxicology). Module 5: Clinical study reports (Efficacy and Safety data from human studies).
ProductDossier TouchBase
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