Regulatory Document Specialist

We are seeking a medical professional to fill the role of Clinical Documentation Specialist in Nashik, India.The ideal candidate will have at least 1 year of experience in clinical documentation and coding, specifically in emergency medicine and operating rooms. They should be certified by AAPC or AHIMA with CPC/COC/CCS certifications.Key responsibilities...

Technical Documentation SpecialistJob Overview:This role involves creating and revising technical documentation that meets industry standards.

Document Author SpecialistThe Document Author Specialist is responsible for creating and maintaining user manuals, documentation, and technical guides for model libraries and tools methodologies.Key areas of focus include:Developing high-quality documentation in DITA XML using Oxygen Author, adhering to industry guidelines and building the doc package using...

Regulatory Affairs Position OverviewWe are seeking a detail-oriented regulatory affairs professional to support end-to-end submissions for global markets.Prepare variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.Contribute to lifecycle management activities by helping to compile and review CTD...

Key ResponsibilitiesObtain and renew mandatory licenses and approvals including PCPNDT (Pre-Conception and Pre-Natal Diagnostic Techniques) Act approvals, ART Registration, Bombay Nursing Home Registration, Fire NOC, Change of Usage Permissions, Bio-Medical Waste Management approvals, Pollution Control Board clearance, Trade license.Ensure timely renewal of...

Regulatory Affairs AssociateWe are seeking a detail-oriented professional to support end-to-end submissions for global markets.Key Responsibilities:Lifecycle Management (LCM): Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.CTD Dossier Modules Compilation: Contribute to Lifecycle...

Regulatory Intelligence AnalystWe are seeking an experienced Regulatory Intelligence Analyst to join our team. As a key member of our regulatory intelligence team, you will be responsible for monitoring and analyzing the global regulatory landscape within the life sciences industry.Responsibilities:Participate in global regulatory intelligence activities,...

Computer Validation EngineerWe are seeking a highly skilled and detail-oriented CSV Technical Writer to join our team.This role demands strong documentation capabilities, effective communication, and deep exposure to the pharmaceutical industry and CSV practices.The ideal candidate will be proficient in stakeholder management, user story writing, and...

Position Overview:We are seeking a detail-oriented RA-CMC Associate to support end-to-end submissions for global markets.Required exposure includes Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Key responsibilities:Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global...

Job Title:Technical Documentation SpecialistIn this role, you will be responsible for creating and maintaining technical documentation, specifically Service Bulletins, for aircraft systems. Your tasks will include analyzing source files, authoring technical content, and collaborating with cross-functional teams to ensure accurate and complete documentation.