eCTD Regulatory Document Publisher

Technical Transfer Project ManagerThe ideal candidate for this role will possess a strong background in project management, with experience in technology transfer and formulation development. They should be well-versed in regulatory guidelines, such as ICH, ANVISA, USFDA, and EMA, as well as have knowledge of eCTD dossier modules and various regulatory...

Regulatory Affairs ProfessionalWe are seeking a highly skilled professional to lead and manage CMC regulatory activities for USFDA submissions, including ANDA preparation, review, and filing.This critical role requires a deep understanding of regulatory affairs and a proven track record of success.Key Responsibilities:Manage CMC regulatory activities for...

Regulatory Affairs SpecialistThis role is pivotal in ensuring adherence to global regulations and country-specific requirements.Screen documents for product registration as per country guidelines.Compile and review product dossiers meeting customer and regulatory needs.Key QualificationsGraduate degree in Pharmacy, Life Sciences, or a related field.Minimum 3...

As a seasoned professional, you will be responsible for developing and implementing efficient documentation processes and systems. Your key responsibilities include:Documentation DevelopmentDesign and implement error-free and fast documentation procedures.Ensure compliance with regulatory requirements for export/import documentation cycles.Import Manifest...

Job Title: Regulatory Affairs ExpertLocation: Remote Position Overview:We seek an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable...

Job Opportunity: Regulatory Affairs AssociateAbout the RoleWe are seeking a detail-oriented Regulatory Affairs (RA) professional to support end-to-end submissions for global markets.The ideal candidate will have experience in managing initial submissions, variations, and full lifecycle management deliverables.This is an excellent opportunity for someone who...

Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Associate to support end-to-end submissions for global markets.Key Responsibilities:Prepare variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.Contribute to Lifecycle Management (LCM) activities by helping to compile...

About the JobAs a Regulatory Intelligence Coordinator, you will play a critical role in monitoring and analyzing the global regulatory landscape within the life sciences industry.You will support our regulatory intelligence products and services by actively participating in global monitoring, surveillance, and data acquisition activities. You will work...

Key Clinical Trial Documents SpecialistAs a Key Clinical Trial Documents Specialist, you will be responsible for developing high-quality clinical trial documents. This includes protocols, Investigator's Brochures, Informed Consent Forms, Case Report Forms, and Clinical Study Reports.ResponsibilitiesTranslate complex scientific data into clear, regulatory...

Job Title: CSV Technical WriterWe are seeking a skilled professional to fill the role of a CSV Technical Writer.This position requires strong documentation capabilities, effective communication, and deep exposure to the pharmaceutical industry and CSV practices.About the RoleThe successful candidate will be responsible for developing comprehensive and...